## Protocol Section
### Identification Module
**NCT ID:** NCT02237079

**Acronym:** BIM

**Brief Title:** Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM)

**Official Title:** Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM)

#### Organization Study ID Info
**ID:** WI190523
#### Organization
**Class:** OTHER
**Full Name:** Tulane University
### Status Module
#### Completion Date
**Date:** 2018-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-06-26

**Type:** ACTUAL

**Last Update Submit Date:** 2023-05-30

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-04

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2023-06-26

**Type:** ACTUAL

**Results First Submit Date:** 2023-02-28

**Results First Submit QC Date:** 2023-05-30

#### Start Date
**Date:** 2014-12

**Type:** ACTUAL

**Status Verified Date:** 2023-05

#### Study First Post Date
**Date:** 2014-09-11
**Type:** ESTIMATED
**Study First Submit Date:** 2014-08-26
**Study First Submit QC Date:** 2014-09-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Tulane University Health Sciences Center

#### Responsible Party

**Investigator Affiliation:** Tulane University Health Sciences Center

**Investigator Full Name:** Franck Mauvais-Jarvis

**Investigator Title:** Professor of Medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The goal of this pilot clinical study is to perform a randomized placebo-controlled study to assess the beneficial effect of a 3 month-treatment with Bazedoxifene/Conjugated Estrogens (BZA/CE) vs. placebo on glucose homeostasis and body composition in 20 post-menopausal women. The recruitment will be performed at Tulane Health Sciences Center.

### Conditions Module

**Conditions:**

- Obesity

- Glucose Homeostasis

- Postmenopausal Symptoms

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 17

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants assigned to BZA/CE will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg. BZA/CE (bazedoxifene/conjugated estrogens) tablets, 0.45 mg/20 mg are oval, biconvex, pink tablets, branded with "0.45/20" in black ink on one side. The recommended and only FDA approved dosage is one BZA/CE tablet daily, taken without regard to meals. Tablets should be swallowed whole. If a dose of BZA/CE is missed, participants will be instructed to take it as soon as remembered unless it is almost time for the next scheduled dose. They should not take two doses at the same time. The dose is one tablet per day independent of weight and fat mass. Participants will be provided with information about BZA/CE and its potential side effects and contraindications.

**Intervention Names:**

- Drug: Bazedoxifene/Conjugated Estrogens (BZA/CE)

**Label:** Bazedoxifene/Conjugated Estrogens (BZA/CE)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants assigned to placebo will receive a daily tablet that matches the BZA/CE to maintain the blind. Placebo tablets, 0.45 mg/20 mg are oval, biconvex, pink tablets, branded with "0.45/20" in black ink on one side. Also to assure the blind is maintain, participants in the placebo group will be given the same instructions for taking the study medication.Tablets should be swallowed whole. If a dose, participants will be instructed to take it as soon as remembered unless it is almost time for the next scheduled dose. They should not take two doses at the same time. The dose is one tablet per day independent of weight and fat mass. Participants will be provided with information about BZA/CE and its potential side effects and contraindications, again to maintain the blind.

**Intervention Names:**

- Drug: Placebo Oral Tablet

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Bazedoxifene/Conjugated Estrogens (BZA/CE)

**Description:** Daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.

**Name:** Bazedoxifene/Conjugated Estrogens (BZA/CE)

**Other Names:**

- DUAVEE

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Daily placebo tablet

**Name:** Placebo Oral Tablet

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Body composition will be assessed through change in body mass index at baseline and at 3 months post-treatment.

**Measure:** Change in Body Mass Index

**Time Frame:** Change at 3 months from baseline

**Description:** Body composition will be assessed through change in waist-to-hip ratio at baseline and at 3 months post-treatment.

**Measure:** Effect of CE/BZA on Body Composition Using Waist-to-hip Ratio

**Time Frame:** Change at 3 months from baseline

**Description:** Dual-Energy X-ray Absorptiometry was used to assess body composition. DXA uses an x-ray technique to look at the density of the body and can then estimate the amount of lean muscle mass and fat tissue. Body composition will be assessed through change in DXA body composition at baseline and at 3 months post-treatment.

**Measure:** Change in Body Composition Using Dual-energy X-ray Absorptiometry (DXA)

**Time Frame:** Change at 3 months from baseline

**Description:** This will be assessed through an IV Glucose Tolerance Test (IVGTT) conducted at baseline and 3 months to measure the change in acute insulin response to glucose. IVGTT data derived by MINMOD Millennium software. MINMOD: a computer program to calculate insulin sensitivity and pancreatic responsivity from the frequently sampled intravenous glucose tolerance test. Acute Insulin Response (AIRg) to Intravenous Glucose is based on glucose and insulin levels obtained during the frequently sampled intravenous glucose tolerance test and calculated using a mathematical model. AIRg is measured as the magnitude of the insulin response to an intravenous glucose injection following glucose administration. A low AIRg indicates decreased ability of the pancreas to secrete insulin.

**Measure:** Change in Acute Insulin Response to Glucose (AIRg)

**Time Frame:** Change at 3 months from baseline

**Description:** This will be assessed through an IV Glucose Tolerance Test (IVGTT) conducted at baseline and 3 months to measure the change in basal glucose concentration. IVGTT data derived by MINMOD Millennium software.

**Measure:** Change in Basal Glucose Concentration (Gb)

**Time Frame:** Change at 3 months from baseline

**Description:** Disposition index (DI) is the product of insulin sensitivity times the amount of insulin secreted in response to blood glucose levels. DI is commonly used as a measure of β-cell function. This will be assessed through an IV Glucose Tolerance Test (IVGTT) conducted at baseline and 3 months to measure the change in disposition index (DI). IVGTT data derived by MINMOD Millennium software. DI is based on glucose and insulin levels obtained during the frequently sampled intravenous glucose tolerance test and calculated using a mathematical model. DI is the product of insulin sensitivity and the amount of insulin secreted in response to blood glucose levels. Disposition index is used as a measure of beta cell function and the ability of the body to dispose of a glucose load. A low DI is indicative of a higher risk of developing diabetes.

**Measure:** Change in Disposition Index (DI)

**Time Frame:** Change at 3 months from baseline

**Description:** SI indicates the net capacity for insulin to promote the disposal of glucose and to inhibit the endogenous production of glucose. This will be assessed through an IV Glucose Tolerance Test (IVGTT) conducted at baseline and 3 months to measure the change in insulin sensitivity (SI) index. IVGTT data derived by MINMOD Millennium software. SI is based on glucose and insulin levels obtained during the frequently sampled intravenous glucose tolerance test and calculated using a mathematical model. SI is a measure of tissue response to circulating insulin in the blood following glucose injection. A low SI signifies low insulin sensitivity and high SI represents high insulin sensitivity.

**Measure:** Change in Insulin Sensitivity (SI) Index

**Time Frame:** Change at 3 months from baseline

**Description:** The homeostasis model assessment of β-cell function (HOMA-β) is an index of insulin secretory function derived from fasting plasma glucose and insulin concentrations. This will be assessed at baseline and 3 months to measure the change in Homeostatic model assessment (HOMA) β-cell function. (HOMA) β-cell function is a method used to quantify beta-cell function from fasting blood samples of insulin and glucose. Normal levels for (HOMA) β-cell function is 107 or more. Lower numbers mean higher risk of developing diabetes.

**Measure:** Change in Homeostatic Model Assessment (HOMA) β-cell Function

**Time Frame:** Change at 3 months from baseline

**Description:** Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin or C-peptide concentrations. This will be assessed at baseline and 3 months to measure the change in Homeostatic model assessment (HOMA) insulin resistance. HOMA IR is a method used to quantify insulin resistance from fasting blood samples of insulin and glucose. Normal levels for HOMA-IR is less than 2.0. Higher levels mean higher risk for developing diabetes.

**Measure:** Change in Homeostatic Model Assessment (HOMA) Insulin Resistance (IR)

**Time Frame:** Change at 3 months from baseline

**Description:** This will be assessed at baseline and 3 months to measure the change in fasting insulin clearance (FIC). FIC derived from fasting C-peptide to insulin ratio.

**Measure:** Change in Fasting Insulin Clearance (FIC)

**Time Frame:** Change at 3 months from baseline

**Description:** This will be assessed through an IV Glucose Tolerance Test (IVGTT) conducted at baseline and 3 months to measure the change in glucose-stimulated insulin clearance (GSIC). GSIC derived from molar ratio of C-peptide to insulin area under curve (AUC) over first 20 min of IVGTT.

**Measure:** Change in Glucose-stimulated Insulin Clearance (GSIC)

**Time Frame:** Change at 3 months from baseline

#### Secondary Outcomes

**Description:** Systematic inflammation will be measured through change in serum biomarkers (Leptin, Lipocalin 2 (LCN2), plasminogen activator inhibitor-1 (PAI-1), Intact OCN) taken at baseline and 3 months.

**Measure:** Measure Change in Serum Biomarkers Panel 1

**Time Frame:** Change at 3 months from baseline

**Description:** Systematic inflammation will be measured through change in serum biomarkers (Adiponectin, RBP4) taken at baseline and 3 months.

**Measure:** Measure Change in Serum Biomarkers Panel 2

**Time Frame:** Change at 3 months from baseline

**Description:** Systematic inflammation will be measured through change in leptin:adiponectin ratio (LAR) taken at baseline and 3 months.

**Measure:** Measure Change in Leptin:Adiponectin Ratio (LAR)

**Time Frame:** Change at 3 months from baseline

**Description:** Systematic inflammation will be measured through change in Fibroblast growth factor-21 (FGF-21) taken at baseline and 3 months.

**Measure:** Measure Change in Fibroblast Growth Factor-21 (FGF-21)

**Time Frame:** Change at 3 months from baseline

**Description:** Systematic inflammation will be measured through change in C-Reactive Protein (CRP) taken at baseline and 3 months.

**Measure:** Measure Change in C-Reactive Protein (CRP)

**Time Frame:** Change at 3 months from baseline

**Description:** Systematic inflammation will be measured through change in Thiobarbituric acid reactive substance (TBARS) taken at baseline and 3 months.

**Measure:** Measure Change in Thiobarbituric Acid Reactive Substance (TBARS)

**Time Frame:** Change at 3 months from baseline

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Post-menopausal women (\<5y since final menstrual period) with age between 50-60y
* Symptomatic (hot flashes, vaginal dryness) or asymptomatic
* BMI 26-45 kg/m2 (Overweight, Obesity I and Obesity II)
* Fasting glucose \<125mg/dl
* Triglycerides \<200mg/dl
* Normal mammogram within past 12 months
* Physician clearance

Exclusion Criteria:

* Amenorrhea from other causes (Hyperandrogenemia and anovulation)
* type 2 and type 1 diabetes
* Medications: diabetes or diabetic drugs, dyslipidemia, estrogen/progestin therapy, antidepressants and antipsychotics, antiretroviral (HIV), oral steroids, weight loss drugs
* ≤ 3 month washout of birth control pill (often prescribed for postmenopausal symptoms)
* Hysterectomy (partial or complete)
* Contraindications to estrogen treatment (unusual vaginal bleeding, blot clots, hepatic disease, bleeding disorder, past/present history of breast or uterine cancer, pregnant, breastfeeding)

**Maximum Age:** 60 Years

**Minimum Age:** 50 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New Orleans

**Country:** United States

**Facility:** Tulane University Clinical Translational Unit

**State:** Louisiana

**Zip:** 70112

#### Overall Officials

**Official 1:**

**Affiliation:** Tulane University

**Name:** Franck Mauvais-Jarvis, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** At this time there is no plan to share individual participant data (IPD)

**IPD Sharing:** NO

## Document Section

### Large Document Module

#### Large Docs

- Date: 2017-07-26

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 515088

- Type Abbrev: Prot_SAP

- Upload Date: 2023-02-27T10:11

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000020845

- Term: Selective Estrogen Receptor Modulators

- ID: D000020847

- Term: Estrogen Receptor Modulators

- ID: D000006727

- Term: Hormone Antagonists

- ID: D000050071

- Term: Bone Density Conservation Agents

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M8116

- Name: Estrogens

- Relevance: HIGH

- As Found: Interviewing

- ID: M8115

- Name: Estrogens, Conjugated (USP)

- Relevance: HIGH

- As Found: Childhood Obesity

- ID: M4854

- Name: Benzocaine

- Relevance: LOW

- As Found: Unknown

- ID: M215342

- Name: Bazedoxifene

- Relevance: HIGH

- As Found: Former

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M22599

- Name: Estrogen Receptor Modulators

- Relevance: LOW

- As Found: Unknown

- ID: M22597

- Name: Selective Estrogen Receptor Modulators

- Relevance: LOW

- As Found: Unknown

- ID: T433

- Name: Tannic Acid

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000447119

- Term: Bazedoxifene

- ID: D000004967

- Term: Estrogens

- ID: D000004966

- Term: Estrogens, Conjugated (USP)

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Bazedoxifene/Conjugated Estrogens (CE/BZA)

**Deaths Num At Risk:** 7

**Description:** Participants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.

**ID:** EG000

**Other Num at Risk:** 7

**Serious Number At Risk:** 7

**Title:** Bazedoxifene/Conjugated Estrogens (CE/BZA)

**Group ID:** EG001

**Title:** Placebo

**Deaths Num At Risk:** 5

**Description:** Participants assigned to placebo will receive a daily tablet that matches the CE/BZA to maintain the blind.

**ID:** EG001

**Other Num Affected:** 1

**Other Num at Risk:** 5

**Serious Number At Risk:** 5

**Title:** Placebo

**Frequency Threshold:** 0

#### Other Events

**Term:** Lower Insulin dose given

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** During the preparations for IVGTT, incorrect (lower) weight of the subject was used to calculate insulin dose, therefore patient was given lower than recommended insulin dose during IVGTT. This event did not affect patient's wellbeing or health.

**Organ System:** Endocrine disorders

**Source Vocabulary:** 

**Time Frame:** The data were collected during baseline visit (during IVGTT for 3 hours) and then again they were collected at the 3 months visit (during IVGTT for 3 hours).

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 7

**Group ID:** BG001

**Value:** 5

**Group ID:** BG002

**Value:** 12

**Units:** Participants

### Group

**ID:** BG000

**Title:** Conjugated Estrogens/Bazedoxifene (CE/BZA)

**Description:** Participants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.

### Group

**ID:** BG001

**Title:** Placebo

**Description:** Participants assigned to placebo will receive a daily tablet that matches the CE/BZA to maintain the blind.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 12

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 52

**Upper Limit:** 56

**Value:** 54

#### Measurement

**Group ID:** BG001

**Lower Limit:** 54

**Upper Limit:** 58

**Value:** 55

#### Measurement

**Group ID:** BG002

**Lower Limit:** 53

**Upper Limit:** 56.5

**Value:** 54.5

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 12

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 10

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 12

**Class Title:** United States

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 1.4

**Upper Limit:** 3.8

**Value:** 2

#### Measurement

**Group ID:** BG001

**Lower Limit:** 2.1

**Upper Limit:** 4.8

**Value:** 4.5

#### Measurement

**Group ID:** BG002

**Lower Limit:** 1.7

**Upper Limit:** 4.4

**Value:** 2.7

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 0.82

**Upper Limit:** 0.95

**Value:** 0.9

#### Measurement

**Group ID:** BG001

**Lower Limit:** 0.82

**Upper Limit:** 0.85

**Value:** 0.84

#### Measurement

**Group ID:** BG002

**Lower Limit:** 0.82

**Upper Limit:** 0.94

**Value:** 0.85

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 30.6

**Upper Limit:** 37

**Value:** 33

#### Measurement

**Group ID:** BG001

**Lower Limit:** 30.7

**Upper Limit:** 38.6

**Value:** 31.2

#### Measurement

**Group ID:** BG002

**Lower Limit:** 30.7

**Upper Limit:** 37.8

**Value:** 32.4

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 91.4

**Upper Limit:** 114.3

**Value:** 109.2

#### Measurement

**Group ID:** BG001

**Lower Limit:** 92

**Upper Limit:** 116.8

**Value:** 106.7

#### Measurement

**Group ID:** BG002

**Lower Limit:** 91.7

**Upper Limit:** 115.6

**Value:** 108

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 83

**Upper Limit:** 114

**Value:** 94

#### Measurement

**Group ID:** BG001

**Lower Limit:** 84

**Upper Limit:** 98

**Value:** 88

#### Measurement

**Group ID:** BG002

**Lower Limit:** 83.5

**Upper Limit:** 108

**Value:** 93.5

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 167

**Upper Limit:** 218

**Value:** 208

#### Measurement

**Group ID:** BG001

**Lower Limit:** 202

**Upper Limit:** 245

**Value:** 216

#### Measurement

**Group ID:** BG002

**Lower Limit:** 190.5

**Upper Limit:** 231.5

**Value:** 211.5

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 45

**Upper Limit:** 69

**Value:** 60

#### Measurement

**Group ID:** BG001

**Lower Limit:** 58

**Upper Limit:** 73

**Value:** 66

#### Measurement

**Group ID:** BG002

**Lower Limit:** 49.5

**Upper Limit:** 71

**Value:** 63

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 99

**Upper Limit:** 148

**Value:** 120

#### Measurement

**Group ID:** BG001

**Lower Limit:** 115

**Upper Limit:** 147

**Value:** 128

#### Measurement

**Group ID:** BG002

**Lower Limit:** 111.5

**Upper Limit:** 147.5

**Value:** 124

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 81

**Upper Limit:** 131

**Value:** 124

#### Measurement

**Group ID:** BG001

**Lower Limit:** 102

**Upper Limit:** 125

**Value:** 103

#### Measurement

**Group ID:** BG002

**Lower Limit:** 82.5

**Upper Limit:** 128.5

**Value:** 113.5

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Age, Continuous
**Unit of Measure:** Years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 6
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Years since last menstrual period (LMP)
**Unit of Measure:** Years
### Measure 7
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Waist-to-hip ratio
**Unit of Measure:** Ratio
### Measure 8
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Body Mass Index (BMI)
**Unit of Measure:** Kg/m^2
### Measure 9
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Waist circumference
**Unit of Measure:** Cm
### Measure 10
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Fasting glucose
**Unit of Measure:** mg/dL
### Measure 11
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Total cholesterol
**Unit of Measure:** mg/dL
### Measure 12
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** High-density lipoprotein (HDL)
**Unit of Measure:** mg/dL
### Measure 13
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Low-density lipoprotein (LDL)
**Unit of Measure:** mg/dL
### Measure 14
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Triglycerides
**Unit of Measure:** mg/dL
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** fmauvais@tulane.edu
**Organization:** Tulane University
**Phone:** 504-988-5990
**Title:** Dr. Franck Mauvais-Jarvis
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
### Outcome Measure 14
### Outcome Measure 15
### Outcome Measure 16
### Outcome Measure 17
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.5
- **Spread:** 
- **Upper Limit:** 0.3
- **Value:** -0.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.6
- **Spread:** 
- **Upper Limit:** -0.3
- **Value:** -0.5
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.06
- **Spread:** 
- **Upper Limit:** 0.03
- **Value:** -0.05
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.02
- **Spread:** 
- **Upper Limit:** 0.00
- **Value:** 0.00
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -571
- **Spread:** 
- **Upper Limit:** 974
- **Value:** 273
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1932
- **Spread:** 
- **Upper Limit:** 467
- **Value:** -1408
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -226
- **Spread:** 
- **Upper Limit:** 611
- **Value:** 1.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -452
- **Spread:** 
- **Upper Limit:** -86
- **Value:** -131
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -550
- **Spread:** 
- **Upper Limit:** 279
- **Value:** -26
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -189
- **Spread:** 
- **Upper Limit:** -116
- **Value:** -178
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -63
- **Spread:** 
- **Upper Limit:** 118
- **Value:** 46
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -134
- **Spread:** 
- **Upper Limit:** -23
- **Value:** -47
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -31
- **Spread:** 
- **Upper Limit:** 444
- **Value:** 189
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -47
- **Spread:** 
- **Upper Limit:** -9
- **Value:** -25
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -9.2
- **Spread:** 
- **Upper Limit:** -1.7
- **Value:** -5.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.9
- **Spread:** 
- **Upper Limit:** 4.9
- **Value:** 2.7
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -19
- **Spread:** 
- **Upper Limit:** 841
- **Value:** 500
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 28
- **Spread:** 
- **Upper Limit:** 572
- **Value:** 267
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.50
- **Spread:** 
- **Upper Limit:** 0.19
- **Value:** -0.24
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.12
- **Spread:** 
- **Upper Limit:** 1.82
- **Value:** 1.35
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.9
- **Spread:** 
- **Upper Limit:** 320.6
- **Value:** 18.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -39.9
- **Spread:** 
- **Upper Limit:** 0.1
- **Value:** -25.5
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.18
- **Spread:** 
- **Upper Limit:** 0.34
- **Value:** 0.15
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.10
- **Spread:** 
- **Upper Limit:** 0.24
- **Value:** -0.01
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -11.56
- **Spread:** 
- **Upper Limit:** 0.78
- **Value:** -3.50
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.70
- **Spread:** 
- **Upper Limit:** -0.00
- **Value:** -0.25
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -123.6
- **Spread:** 
- **Upper Limit:** 6.9
- **Value:** -32.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -20.5
- **Spread:** 
- **Upper Limit:** 25.8
- **Value:** -1.85
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -7.2
- **Spread:** 
- **Upper Limit:** 9.5
- **Value:** -1.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.1
- **Spread:** 
- **Upper Limit:** 10.5
- **Value:** 0.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -3
- **Spread:** 
- **Upper Limit:** 3.5
- **Value:** -1.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -4.9
- **Spread:** 
- **Upper Limit:** 2.2
- **Value:** -3.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -5.2
- **Spread:** 
- **Upper Limit:** -1.4
- **Value:** -1.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.4
- **Spread:** 
- **Upper Limit:** 3.3
- **Value:** 1.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.7
- **Spread:** 
- **Upper Limit:** 3.1
- **Value:** 0.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.1
- **Spread:** 
- **Upper Limit:** 2.7
- **Value:** -0.9
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -5.6
- **Spread:** 
- **Upper Limit:** 14.5
- **Value:** -0.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -24.1
- **Spread:** 
- **Upper Limit:** 4.6
- **Value:** -4.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.8
- **Spread:** 
- **Upper Limit:** -0.5
- **Value:** -1.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -2.6
- **Spread:** 
- **Upper Limit:** -0.4
- **Value:** -2.5
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.04
- **Spread:** 
- **Upper Limit:** 4.96
- **Value:** 2.71
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.02
- **Spread:** 
- **Upper Limit:** 4.03
- **Value:** 1.55
**Title:** 
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -208
- **Spread:** 
- **Upper Limit:** 24
- **Value:** -134
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -226
- **Spread:** 
- **Upper Limit:** -48
- **Value:** -89
**Title:** 
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.66
- **Spread:** 
- **Upper Limit:** 0.45
- **Value:** -0.41
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.82
- **Spread:** 
- **Upper Limit:** -0.06
- **Value:** -0.39
**Title:** 
#### Outcome Measure 17
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -3.3
- **Spread:** 
- **Upper Limit:** -0.4
- **Value:** -1.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.2
- **Spread:** 
- **Upper Limit:** 0.0
- **Value:** -1.2
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Body composition will be assessed through change in body mass index at baseline and at 3 months post-treatment.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** Change at 3 months from baseline
**Title:** Change in Body Mass Index
**Type:** PRIMARY
**Unit of Measure:** Kg/m^2
##### Group
**Description:** Participants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.
**ID:** OG000
**Title:** Bazedoxifene/Conjugated Estrogens (CE/BZA)
##### Group
**Description:** Participants assigned to placebo will receive a daily tablet that matches the CE/BZA to maintain the blind.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 2
**Description:** Body composition will be assessed through change in waist-to-hip ratio at baseline and at 3 months post-treatment.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** Change at 3 months from baseline
**Title:** Effect of CE/BZA on Body Composition Using Waist-to-hip Ratio
**Type:** PRIMARY
**Unit of Measure:** Ratio
##### Group
**Description:** Participants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.
**ID:** OG000
**Title:** Bazedoxifene/Conjugated Estrogens (CE/BZA)
##### Group
**Description:** Participants assigned to placebo will receive a daily tablet that matches the CE/BZA to maintain the blind.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 3
**Description:** Dual-Energy X-ray Absorptiometry was used to assess body composition. DXA uses an x-ray technique to look at the density of the body and can then estimate the amount of lean muscle mass and fat tissue. Body composition will be assessed through change in DXA body composition at baseline and at 3 months post-treatment.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** Change at 3 months from baseline
**Title:** Change in Body Composition Using Dual-energy X-ray Absorptiometry (DXA)
**Type:** PRIMARY
**Unit of Measure:** g
##### Group
**Description:** Participants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.
**ID:** OG000
**Title:** Bazedoxifene/Conjugated Estrogens (CE/BZA)
##### Group
**Description:** Participants assigned to placebo will receive a daily tablet that matches the CE/BZA to maintain the blind.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 4
**Description:** This will be assessed through an IV Glucose Tolerance Test (IVGTT) conducted at baseline and 3 months to measure the change in acute insulin response to glucose. IVGTT data derived by MINMOD Millennium software. MINMOD: a computer program to calculate insulin sensitivity and pancreatic responsivity from the frequently sampled intravenous glucose tolerance test. Acute Insulin Response (AIRg) to Intravenous Glucose is based on glucose and insulin levels obtained during the frequently sampled intravenous glucose tolerance test and calculated using a mathematical model. AIRg is measured as the magnitude of the insulin response to an intravenous glucose injection following glucose administration. A low AIRg indicates decreased ability of the pancreas to secrete insulin.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** Note that for technical reasons, the IVGTT serum was processed in only 11 of 12 subjects (CE/BZA n = 6).
**Reporting Status:** POSTED
**Time Frame:** Change at 3 months from baseline
**Title:** Change in Acute Insulin Response to Glucose (AIRg)
**Type:** PRIMARY
**Unit of Measure:** uU/l^-1.min^-1
##### Group
**Description:** Participants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.
**ID:** OG000
**Title:** Bazedoxifene/Conjugated Estrogens (CE/BZA)
##### Group
**Description:** Participants assigned to placebo will receive a daily tablet that matches the CE/BZA to maintain the blind.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 5
**Description:** This will be assessed through an IV Glucose Tolerance Test (IVGTT) conducted at baseline and 3 months to measure the change in basal glucose concentration. IVGTT data derived by MINMOD Millennium software.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** Note that for technical reasons, the IVGTT serum was processed in only 11 of 12 subjects (CE/BZA n = 6).
**Reporting Status:** POSTED
**Time Frame:** Change at 3 months from baseline
**Title:** Change in Basal Glucose Concentration (Gb)
**Type:** PRIMARY
**Unit of Measure:** mg/dL
##### Group
**Description:** Participants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.
**ID:** OG000
**Title:** Bazedoxifene/Conjugated Estrogens (CE/BZA)
##### Group
**Description:** Participants assigned to placebo will receive a daily tablet that matches the CE/BZA to maintain the blind.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 6
**Description:** Disposition index (DI) is the product of insulin sensitivity times the amount of insulin secreted in response to blood glucose levels. DI is commonly used as a measure of β-cell function. This will be assessed through an IV Glucose Tolerance Test (IVGTT) conducted at baseline and 3 months to measure the change in disposition index (DI). IVGTT data derived by MINMOD Millennium software. DI is based on glucose and insulin levels obtained during the frequently sampled intravenous glucose tolerance test and calculated using a mathematical model. DI is the product of insulin sensitivity and the amount of insulin secreted in response to blood glucose levels. Disposition index is used as a measure of beta cell function and the ability of the body to dispose of a glucose load. A low DI is indicative of a higher risk of developing diabetes.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** Note that for technical reasons, the IVGTT serum was processed in only 11 of 12 subjects (CE/BZA n = 6).
**Reporting Status:** POSTED
**Time Frame:** Change at 3 months from baseline
**Title:** Change in Disposition Index (DI)
**Type:** PRIMARY
**Unit of Measure:** Index
##### Group
**Description:** Participants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.
**ID:** OG000
**Title:** Bazedoxifene/Conjugated Estrogens (CE/BZA)
##### Group
**Description:** Participants assigned to placebo will receive a daily tablet that matches the CE/BZA to maintain the blind.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 7
**Description:** SI indicates the net capacity for insulin to promote the disposal of glucose and to inhibit the endogenous production of glucose. This will be assessed through an IV Glucose Tolerance Test (IVGTT) conducted at baseline and 3 months to measure the change in insulin sensitivity (SI) index. IVGTT data derived by MINMOD Millennium software. SI is based on glucose and insulin levels obtained during the frequently sampled intravenous glucose tolerance test and calculated using a mathematical model. SI is a measure of tissue response to circulating insulin in the blood following glucose injection. A low SI signifies low insulin sensitivity and high SI represents high insulin sensitivity.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** Note that for technical reasons, the IVGTT serum was processed in only 11 of 12 subjects (CE/BZA n = 6).
**Reporting Status:** POSTED
**Time Frame:** Change at 3 months from baseline
**Title:** Change in Insulin Sensitivity (SI) Index
**Type:** PRIMARY
**Unit of Measure:** uU/L^-1.min^-1
##### Group
**Description:** Participants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.
**ID:** OG000
**Title:** Bazedoxifene/Conjugated Estrogens (CE/BZA)
##### Group
**Description:** Participants assigned to placebo will receive a daily tablet that matches the CE/BZA to maintain the blind.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 8
**Description:** The homeostasis model assessment of β-cell function (HOMA-β) is an index of insulin secretory function derived from fasting plasma glucose and insulin concentrations. This will be assessed at baseline and 3 months to measure the change in Homeostatic model assessment (HOMA) β-cell function. (HOMA) β-cell function is a method used to quantify beta-cell function from fasting blood samples of insulin and glucose. Normal levels for (HOMA) β-cell function is 107 or more. Lower numbers mean higher risk of developing diabetes.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** Note that for technical reasons, the IVGTT serum was processed in only 11 of 12 subjects (CE/BZA n = 6).
**Reporting Status:** POSTED
**Time Frame:** Change at 3 months from baseline
**Title:** Change in Homeostatic Model Assessment (HOMA) β-cell Function
**Type:** PRIMARY
**Unit of Measure:** uU/mM
##### Group
**Description:** Participants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.
**ID:** OG000
**Title:** Bazedoxifene/Conjugated Estrogens (CE/BZA)
##### Group
**Description:** Participants assigned to placebo will receive a daily tablet that matches the CE/BZA to maintain the blind.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 9
**Description:** Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin or C-peptide concentrations. This will be assessed at baseline and 3 months to measure the change in Homeostatic model assessment (HOMA) insulin resistance. HOMA IR is a method used to quantify insulin resistance from fasting blood samples of insulin and glucose. Normal levels for HOMA-IR is less than 2.0. Higher levels mean higher risk for developing diabetes.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** Note that for technical reasons, the IVGTT serum was processed in only 11 of 12 subjects (CE/BZA n = 6).
**Reporting Status:** POSTED
**Time Frame:** Change at 3 months from baseline
**Title:** Change in Homeostatic Model Assessment (HOMA) Insulin Resistance (IR)
**Type:** PRIMARY
**Unit of Measure:** mM.uU/L^-2
##### Group
**Description:** Participants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.
**ID:** OG000
**Title:** Bazedoxifene/Conjugated Estrogens (CE/BZA)
##### Group
**Description:** Participants assigned to placebo will receive a daily tablet that matches the CE/BZA to maintain the blind.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 10
**Description:** This will be assessed at baseline and 3 months to measure the change in fasting insulin clearance (FIC). FIC derived from fasting C-peptide to insulin ratio.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** Note that for technical reasons, the IVGTT serum was processed in only 11 of 12 subjects (CE/BZA n = 6).
**Reporting Status:** POSTED
**Time Frame:** Change at 3 months from baseline
**Title:** Change in Fasting Insulin Clearance (FIC)
**Type:** PRIMARY
**Unit of Measure:** Ratio
##### Group
**Description:** Participants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.
**ID:** OG000
**Title:** Bazedoxifene/Conjugated Estrogens (CE/BZA)
##### Group
**Description:** Participants assigned to placebo will receive a daily tablet that matches the CE/BZA to maintain the blind.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 11
**Description:** This will be assessed through an IV Glucose Tolerance Test (IVGTT) conducted at baseline and 3 months to measure the change in glucose-stimulated insulin clearance (GSIC). GSIC derived from molar ratio of C-peptide to insulin area under curve (AUC) over first 20 min of IVGTT.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** Note that for technical reasons, the IVGTT serum was processed in only 11 of 12 subjects (CE/BZA n = 6).
**Reporting Status:** POSTED
**Time Frame:** Change at 3 months from baseline
**Title:** Change in Glucose-stimulated Insulin Clearance (GSIC)
**Type:** PRIMARY
**Unit of Measure:** Ratio
##### Group
**Description:** Participants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.
**ID:** OG000
**Title:** Bazedoxifene/Conjugated Estrogens (CE/BZA)
##### Group
**Description:** Participants assigned to placebo will receive a daily tablet that matches the CE/BZA to maintain the blind.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 12
**Description:** Systematic inflammation will be measured through change in serum biomarkers (Leptin, Lipocalin 2 (LCN2), plasminogen activator inhibitor-1 (PAI-1), Intact OCN) taken at baseline and 3 months.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** Change at 3 months from baseline
**Title:** Measure Change in Serum Biomarkers Panel 1
**Type:** SECONDARY
**Unit of Measure:** ng/mL
##### Group
**Description:** Participants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.
**ID:** OG000
**Title:** Bazedoxifene/Conjugated Estrogens (CE/BZA)
##### Group
**Description:** Participants assigned to placebo will receive a daily tablet that matches the CE/BZA to maintain the blind.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 13
**Description:** Systematic inflammation will be measured through change in serum biomarkers (Adiponectin, RBP4) taken at baseline and 3 months.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** Change at 3 months from baseline
**Title:** Measure Change in Serum Biomarkers Panel 2
**Type:** SECONDARY
**Unit of Measure:** ug/mL
##### Group
**Description:** Participants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.
**ID:** OG000
**Title:** Bazedoxifene/Conjugated Estrogens (CE/BZA)
##### Group
**Description:** Participants assigned to placebo will receive a daily tablet that matches the CE/BZA to maintain the blind.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 14
**Description:** Systematic inflammation will be measured through change in leptin:adiponectin ratio (LAR) taken at baseline and 3 months.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** Change at 3 months from baseline
**Title:** Measure Change in Leptin:Adiponectin Ratio (LAR)
**Type:** SECONDARY
**Unit of Measure:** Ratio
##### Group
**Description:** Participants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.
**ID:** OG000
**Title:** Bazedoxifene/Conjugated Estrogens (CE/BZA)
##### Group
**Description:** Participants assigned to placebo will receive a daily tablet that matches the CE/BZA to maintain the blind.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 15
**Description:** Systematic inflammation will be measured through change in Fibroblast growth factor-21 (FGF-21) taken at baseline and 3 months.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** Change at 3 months from baseline
**Title:** Measure Change in Fibroblast Growth Factor-21 (FGF-21)
**Type:** SECONDARY
**Unit of Measure:** pg/mL
##### Group
**Description:** Participants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.
**ID:** OG000
**Title:** Bazedoxifene/Conjugated Estrogens (CE/BZA)
##### Group
**Description:** Participants assigned to placebo will receive a daily tablet that matches the CE/BZA to maintain the blind.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 16
**Description:** Systematic inflammation will be measured through change in C-Reactive Protein (CRP) taken at baseline and 3 months.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** Change at 3 months from baseline
**Title:** Measure Change in C-Reactive Protein (CRP)
**Type:** SECONDARY
**Unit of Measure:** mg/mL
##### Group
**Description:** Participants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.
**ID:** OG000
**Title:** Bazedoxifene/Conjugated Estrogens (CE/BZA)
##### Group
**Description:** Participants assigned to placebo will receive a daily tablet that matches the CE/BZA to maintain the blind.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 17
**Description:** Systematic inflammation will be measured through change in Thiobarbituric acid reactive substance (TBARS) taken at baseline and 3 months.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** Change at 3 months from baseline
**Title:** Measure Change in Thiobarbituric Acid Reactive Substance (TBARS)
**Type:** SECONDARY
**Unit of Measure:** nmol/mL
##### Group
**Description:** Participants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.
**ID:** OG000
**Title:** Bazedoxifene/Conjugated Estrogens (CE/BZA)
##### Group
**Description:** Participants assigned to placebo will receive a daily tablet that matches the CE/BZA to maintain the blind.
**ID:** OG001
**Title:** Placebo
### Participant Flow Module
#### Group
**Description:** Participants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.
**ID:** FG000
**Title:** Bazedoxifene/Conjugated Estrogens (CE/BZA)
#### Group
**Description:** Participants assigned to placebo will receive a daily tablet that matches the CE/BZA to maintain the blind.
**ID:** FG001
**Title:** Placebo
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 7
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 7
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 5
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 2
**Has Results:** True