## Protocol Section
### Identification Module
**NCT ID:** NCT01070979

**Brief Title:** Hormone Replacement Therapy for Use in Postmenopausal Women for Relief of Hot Flushes and Urogenital Symptoms.

**Official Title:** A Multicenter, Double-Blind, Controlled, Randomized Study to Compare the Efficacy in Relief of Hot Flushes in Women Receiving Oral Estradiol Acetate Tablets, Oral Estradiol Tablets or Oral Conjugated Equine Estrogens

#### Organization Study ID Info
**ID:** PR-03602.1
#### Organization
**Class:** INDUSTRY
**Full Name:** Warner Chilcott
### Status Module
#### Completion Date
**Date:** 2003-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-04-22

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-04-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2003-09

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2011-04-08

**Type:** ESTIMATED

**Results First Submit Date:** 2011-02-14

**Results First Submit QC Date:** 2011-03-09

#### Start Date
**Date:** 2003-02

**Status Verified Date:** 2013-04

#### Study First Post Date
**Date:** 2010-02-18
**Type:** ESTIMATED
**Study First Submit Date:** 2010-02-17
**Study First Submit QC Date:** 2010-02-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Warner Chilcott

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Multicenter, double-blind, controlled, parallel group, randomized study to compare the clinical benefit of Estradiol acetate tablets, estradiol tablets and conjugated equine estrogen tablets, each administered orally, once daily, to postmenopausal women.

### Conditions Module

**Conditions:**

- Hormone Replacement Therapy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 249

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Estradiol acetate

**Label:** Estradiol acetate (E3A)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: Estradiol

**Label:** Estradiol

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Intervention Names:**

- Drug: Conjugated equine estrogens

**Label:** Conjugated equine estrogens (CEE):

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Estradiol acetate (E3A)

**Description:** Tablet containing 0.9 mg E3A, daily oral administration.

**Name:** Estradiol acetate

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Estradiol

**Description:** Tablet containing 1 mg estradiol, daily oral administration.

**Name:** Estradiol

**Other Names:**

- Estrace

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Conjugated equine estrogens (CEE):

**Description:** Tablet containing 0.625 mg CEE, daily oral administration.

**Name:** Conjugated equine estrogens

**Other Names:**

- Premarin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Severity of hot flush definitions: mild - sensation of heat without perspiration, moderate - sensation of heat with perspiration, able to continue activity, severe - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep

**Measure:** Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 4, ITT (Intention to Treat) Population

**Time Frame:** Baseline to Week 4

**Description:** Severity of hot flush definitions: mild - sensation of heat without perspiration, moderate - sensation of heat with perspiration, able to continue activity, severe - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep

**Measure:** Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 12, ITT Population

**Time Frame:** Baseline to Week 12

#### Secondary Outcomes

**Description:** Patient self-reported outcome. Severity of hot flush definitions: mild (1) - sensation of heat without perspiration, moderate (2) - sensation of heat with perspiration, able to continue activity, severe (3) - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep. Minimum 0/no hot flushes, Maximum 3/all severe hot flushes. Lower the score the greater the improvement in reducing hot flushes.

**Measure:** Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 4, ITT Population

**Time Frame:** Baseline to Week 4

**Description:** Patient self-reported outcome. Severity of hot flush definitions: mild (1) - sensation of heat without perspiration, moderate (2) - sensation of heat with perspiration, able to continue activity, severe (3) - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep. Minimum 0/no hot flushes, Maximum 3/all severe hot flushes. Lower the score the greater the improvement in reducing hot flushes.

**Measure:** Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 12, ITT Population

**Time Frame:** Baseline to Week 12

**Description:** Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.

**Measure:** Mean Change From Baseline in Total Urogenital Symptom Score, Week 4, ITT Population

**Time Frame:** Baseline to Week 4

**Description:** Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.

**Measure:** Change From Baseline in Total Urogenital Symptom Score, Week 8, ITT Population

**Time Frame:** Baseline to Week 8

**Description:** Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.

**Measure:** Change From Baseline in Total Urogenital Symptom Score, Week 12, ITT Population

**Time Frame:** Baseline to Week 12

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Age ≥ 40 years of age; bilateral oophorectomy ≥ 35 years of age.
2. Non-hysterectomized women:

   * Amenorrhea for ≥ 12 months or
   * Amenorrhea for ≤ 12 months, but longer than 6 months, and serum FSH (follicle stimulating hormone) levels \> 40 units/L and serum estradiol levels \< 20 pg /mL,

   Hysterectomized women:
   * Bilateral oophorectomy - subjects may enter the study 6 weeks after surgery or
   * History of removal of ovaries may be confirmed by - serum FSH levels \> 40 units/L and serum estradiol levels \< 20 pg/mL or via surgical report / ultrasound.
3. Seven or more moderate or severe hot flushes daily for 1 week or 60 or more moderate or severe flushes in 1 week during the 2 week screening period prior to study entry.

Exclusion Criteria:

1. Hormone therapy administered via the following routes and during the specified timeframes: oral within 8 weeks, vaginal (rings, creams, gels) within 1 week, transdermal within 4 weeks, intramuscular within 6 weeks, progestational implants, estrogen or estrogen/progestational injectable drug therapy within 3 months, estrogen pellet or progestational injectable within 6 months.
2. Abnormal Pap smear suggestive of low grade squamous intraepithelial lesion (LGSIL) or worse. Enrollment of subjects with an ASCUS (atypical squamous cells of undetermined significance) interpretation must be discussed with the sponsor prior to randomization.
3. Urinary tract infection
4. Congestive heart failure
5. Uncontrolled hypertension; sitting systolic BP ≥ 160 mmHg or diastolic ≥ 95 mmHg
6. History of stroke or transient ischemic attacks
7. Treatment with anticoagulants (heparin or warfarin).
8. Uncontrolled thyroid disorders.
9. Insulin-dependent diabetes mellitus.
10. Increase frequency or severity of headaches including migraines during previous estrogen therapy.

**Minimum Age:** 35 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Phoenix

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Arizona

**Zip:** 85031

**Location 2:**

**City:** Carmichael

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** California

**Zip:** 95608

**Location 3:**

**City:** San Diego

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** California

**Zip:** 92108

**Location 4:**

**City:** San Diego

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** California

**Zip:** 92123

**Location 5:**

**City:** Aventura

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Florida

**Zip:** 33180

**Location 6:**

**City:** Boynton Beach

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Florida

**Zip:** 33437

**Location 7:**

**City:** Clearwater

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Florida

**Zip:** 33765

**Location 8:**

**City:** Daytona Beach

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Florida

**Zip:** 32114

**Location 9:**

**City:** Gainesville

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Florida

**Zip:** 32605

**Location 10:**

**City:** Longwood

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Florida

**Zip:** 32779

**Location 11:**

**City:** Melbourne

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Florida

**Zip:** 32935

**Location 12:**

**City:** Miami

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Florida

**Zip:** 33143

**Location 13:**

**City:** Palm Springs

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Florida

**Zip:** 33461

**Location 14:**

**City:** Pinellas Park

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Florida

**Zip:** 33781

**Location 15:**

**City:** Sarasota

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Florida

**Zip:** 34232

**Location 16:**

**City:** Venice

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Florida

**Zip:** 34285

**Location 17:**

**City:** Roswell

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Georgia

**Zip:** 30075

**Location 18:**

**City:** Chicago

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Illinois

**Zip:** 60612

**Location 19:**

**City:** Peoria

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Illinois

**Zip:** 61615

**Location 20:**

**City:** Laurel

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Maryland

**Zip:** 20707

**Location 21:**

**City:** Lincoln

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Nebraska

**Zip:** 68510

**Location 22:**

**City:** Raleigh

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** North Carolina

**Zip:** 27612

**Location 23:**

**City:** Winston Salem

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** North Carolina

**Zip:** 27103

**Location 24:**

**City:** Cleveland

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Ohio

**Zip:** 44122

**Location 25:**

**City:** Columbus

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Ohio

**Zip:** 43212

**Location 26:**

**City:** Mogadore

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Ohio

**Zip:** 44260

**Location 27:**

**City:** Portland

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Oregon

**Zip:** 97201

**Location 28:**

**City:** Pittsburgh

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Pennsylvania

**Zip:** 15206

**Location 29:**

**City:** Nashville

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Tennessee

**Zip:** 37203

**Location 30:**

**City:** Salt Lake City

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Utah

**Zip:** 84124

**Location 31:**

**City:** Spokane

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Washington

**Zip:** 99201

**Location 32:**

**City:** Tacoma

**Country:** United States

**Facility:** Warner Chilcott Investigational Site

**State:** Washington

**Zip:** 98405

#### Overall Officials

**Official 1:**

**Affiliation:** Warner Chilcott

**Name:** Herman Ellman, MD

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M8610

- Name: Flushing

- Relevance: LOW

- As Found: Unknown

- ID: M21519

- Name: Hot Flashes

- Relevance: HIGH

- As Found: Hot Flushes

### Condition Browse Module - Meshes

- ID: D000019584

- Term: Hot Flashes

### 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: D000080066

- Term: Contraceptive Agents, Hormonal

- ID: D000003270

- Term: Contraceptive Agents

- ID: D000012102

- Term: Reproductive Control Agents

- ID: D000003271

- Term: Contraceptive Agents, Female

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Repr

- Name: Reproductive Control Agents

### Intervention Browse Module - Browse Leaves

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M8116

- Name: Estrogens

- Relevance: HIGH

- As Found: Interviewing

- ID: M266279

- Name: Estradiol 17 beta-cypionate

- Relevance: HIGH

- As Found: Cell lymphoma

- ID: M266280

- Name: Estradiol 3-benzoate

- Relevance: HIGH

- As Found: Cell lymphoma

- ID: M8108

- Name: Estradiol

- Relevance: HIGH

- As Found: Cell lymphoma

- ID: M234941

- Name: Polyestradiol phosphate

- Relevance: HIGH

- As Found: Cell lymphoma

- ID: M8115

- Name: Estrogens, Conjugated (USP)

- Relevance: HIGH

- As Found: Golytely

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M6494

- Name: Contraceptive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M2116

- Name: Contraceptive Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M6495

- Name: Contraceptive Agents, Female

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000007630

- Term: Estradiol 17 beta-cypionate

- ID: C000074283

- Term: Estradiol 3-benzoate

- ID: D000004958

- Term: Estradiol

- ID: C000008958

- Term: Polyestradiol phosphate

- ID: D000004967

- Term: Estrogens

- ID: D000004966

- Term: Estrogens, Conjugated (USP)

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.

#### Event Groups

**Group ID:** EG000

**Title:** Estradiol Acetate (E3A)

**Description:** 1 tablet daily containing 0.9 mg estradiol acetate

**ID:** EG000

**Other Num Affected:** 19

**Other Num at Risk:** 79

**Serious Number At Risk:** 79

**Title:** Estradiol Acetate (E3A)

**Group ID:** EG001

**Title:** Estradiol

**Description:** 1 tablet daily containing 1 mg estradiol

**ID:** EG001

**Other Num Affected:** 25

**Other Num at Risk:** 84

**Serious Number Affected:** 1

**Serious Number At Risk:** 84

**Title:** Estradiol

**Group ID:** EG002

**Title:** Conjugated Equine Estrogens (CEE)

**Description:** 1 tablet daily containing 0.625 mg conjugated equine estrogen

**ID:** EG002

**Other Num Affected:** 30

**Other Num at Risk:** 85

**Serious Number At Risk:** 85

**Title:** Conjugated Equine Estrogens (CEE)

**Frequency Threshold:** 3

#### Other Events

**Term:** Breast Tenderness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA (6.0)

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (6.0)

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (6.0)

**Term:** Metrorrhagia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA (6.0)

**Term:** Abdominal Distention

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (6.0)

**Term:** Vaginosis Fungal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (6.0)

**Term:** Weight Increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (6.0)

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (6.0)

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (6.0)

**Term:** Anxiety

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (6.0)

#### Serious Events

**Term:** metrorrhagia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA (6.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 79

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 84

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 85

**Time Frame:** 7 months

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 79

**Group ID:** BG001

**Value:** 85

**Group ID:** BG002

**Value:** 85

**Group ID:** BG003

**Value:** 249

**Units:** Participants

### Group

**ID:** BG000

**Title:** Estradiol Acetate (E3A)

**Description:** 1 tablet daily containing 0.9 mg estradiol acetate

### Group

**ID:** BG001

**Title:** Estradiol

**Description:** 1 tablet daily containing 1 mg estradiol

### Group

**ID:** BG002

**Title:** Conjugated Equine Estrogens (CEE)

**Description:** 1 tablet daily containing 0.625 mg conjugated equine estrogen

### Group

**ID:** BG003

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 6.6

**Value:** 52.2

#### Measurement

**Group ID:** BG001

**Spread:** 7.0

**Value:** 52.3

#### Measurement

**Group ID:** BG002

**Spread:** 6.3

**Value:** 53.8

#### Measurement

**Group ID:** BG003

**Spread:** 6.7

**Value:** 52.8

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 79

#### Measurement

**Group ID:** BG001

**Value:** 85

#### Measurement

**Group ID:** BG002

**Value:** 85

#### Measurement

**Group ID:** BG003

**Value:** 249

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 79

#### Measurement

**Group ID:** BG001

**Value:** 85

#### Measurement

**Group ID:** BG002

**Value:** 85

#### Measurement

**Group ID:** BG003

**Value:** 249

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** LTE60
**Restrictive Agreement:** True
### Point of Contact
**Email:** gwulff@wcrx.com
**Organization:** Warner Chilcott
**Phone:** 973-442-3376
**Title:** Grexan Wulff, Manager Regulatory Affairs
## 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
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.5
- **Upper Limit:** 
- **Value:** -54.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.721
- **Spread:** 4.5
- **Upper Limit:** 1.048
- **Value:** -62.0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 0.833
- **Spread:** 4.3
- **Upper Limit:** 1.178
- **Value:** -54.5
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.106
- **Upper Limit:** 
- **Value:** -0.53
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.106
- **Upper Limit:** 
- **Value:** -0.51
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.102
- **Upper Limit:** 
- **Value:** -0.59
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.8
- **Upper Limit:** 
- **Value:** -63.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.7
- **Upper Limit:** 
- **Value:** -72.2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 4.6
- **Upper Limit:** 
- **Value:** -67.2
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.127
- **Upper Limit:** 
- **Value:** -1.05
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.125
- **Upper Limit:** 
- **Value:** -1.34
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.122
- **Upper Limit:** 
- **Value:** -1.17
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.413
- **Upper Limit:** 
- **Value:** -1.89
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.407
- **Upper Limit:** 
- **Value:** -2.26
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.398
- **Upper Limit:** 
- **Value:** -1.96
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.432
- **Upper Limit:** 
- **Value:** -1.96
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.425
- **Upper Limit:** 
- **Value:** -2.58
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.416
- **Upper Limit:** 
- **Value:** -2.42
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.437
- **Upper Limit:** 
- **Value:** -2.49
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.431
- **Upper Limit:** 
- **Value:** -2.59
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.422
- **Upper Limit:** 
- **Value:** -2.52
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Severity of hot flush definitions: mild - sensation of heat without perspiration, moderate - sensation of heat with perspiration, able to continue activity, severe - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)
**Reporting Status:** POSTED
**Time Frame:** Baseline to Week 4
**Title:** Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 4, ITT (Intention to Treat) Population
**Type:** PRIMARY
**Unit of Measure:** Change in Hot Flush Count
##### Group
**Description:** 1 tablet daily containing 0.9 mg estradiol acetate
**ID:** OG000
**Title:** Estradiol Acetate (E3A)
##### Group
**Description:** 1 tablet daily containing 1 mg estradiol
**ID:** OG001
**Title:** Estradiol
##### Group
**Description:** 1 tablet daily containing 0.625 mg conjugated equine estrogen
**ID:** OG002
**Title:** Conjugated Equine Estrogens (CEE)
#### Outcome Measure 2
**Description:** Patient self-reported outcome. Severity of hot flush definitions: mild (1) - sensation of heat without perspiration, moderate (2) - sensation of heat with perspiration, able to continue activity, severe (3) - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep. Minimum 0/no hot flushes, Maximum 3/all severe hot flushes. Lower the score the greater the improvement in reducing hot flushes.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)
**Reporting Status:** POSTED
**Time Frame:** Baseline to Week 4
**Title:** Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 4, ITT Population
**Type:** SECONDARY
**Unit of Measure:** Change in Score
##### Group
**Description:** 1 tablet daily containing 0.9 mg estradiol acetate
**ID:** OG000
**Title:** Estradiol Acetate (E3A)
##### Group
**Description:** 1 tablet daily containing 1 mg estradiol
**ID:** OG001
**Title:** Estradiol
##### Group
**Description:** 1 tablet daily containing 0.625 mg conjugated equine estrogen
**ID:** OG002
**Title:** Conjugated Equine Estrogens (CEE)
#### Outcome Measure 3
**Description:** Severity of hot flush definitions: mild - sensation of heat without perspiration, moderate - sensation of heat with perspiration, able to continue activity, severe - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)
**Reporting Status:** POSTED
**Time Frame:** Baseline to Week 12
**Title:** Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 12, ITT Population
**Type:** PRIMARY
**Unit of Measure:** Change in Hot Flush Count
##### Group
**Description:** 1 tablet daily containing 0.9 mg estradiol acetate
**ID:** OG000
**Title:** Estradiol Acetate (E3A)
##### Group
**Description:** 1 tablet daily containing 1 mg estradiol
**ID:** OG001
**Title:** Estradiol
##### Group
**Description:** 1 tablet daily containing 0.625 mg conjugated equine estrogen
**ID:** OG002
**Title:** Conjugated Equine Estrogens (CEE)
#### Outcome Measure 4
**Description:** Patient self-reported outcome. Severity of hot flush definitions: mild (1) - sensation of heat without perspiration, moderate (2) - sensation of heat with perspiration, able to continue activity, severe (3) - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep. Minimum 0/no hot flushes, Maximum 3/all severe hot flushes. Lower the score the greater the improvement in reducing hot flushes.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)
**Reporting Status:** POSTED
**Time Frame:** Baseline to Week 12
**Title:** Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 12, ITT Population
**Type:** SECONDARY
**Unit of Measure:** Change in Score
##### Group
**Description:** 1 tablet daily containing 0.9 mg estradiol acetate
**ID:** OG000
**Title:** Estradiol Acetate (E3A)
##### Group
**Description:** 1 tablet daily containing 1 mg estradiol
**ID:** OG001
**Title:** Estradiol
##### Group
**Description:** 1 tablet daily containing 0.625 mg conjugated equine estrogen
**ID:** OG002
**Title:** Conjugated Equine Estrogens (CEE)
#### Outcome Measure 5
**Description:** Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)
**Reporting Status:** POSTED
**Time Frame:** Baseline to Week 4
**Title:** Mean Change From Baseline in Total Urogenital Symptom Score, Week 4, ITT Population
**Type:** SECONDARY
**Unit of Measure:** Change in Score
##### Group
**Description:** 1 tablet daily containing 0.9 mg estradiol acetate
**ID:** OG000
**Title:** Estradiol Acetate (E3A)
##### Group
**Description:** 1 tablet daily containing 1 mg estradiol
**ID:** OG001
**Title:** Estradiol
##### Group
**Description:** 1 tablet daily containing 0.625 mg conjugated equine estrogen
**ID:** OG002
**Title:** Conjugated Equine Estrogens (CEE)
#### Outcome Measure 6
**Description:** Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)
**Reporting Status:** POSTED
**Time Frame:** Baseline to Week 8
**Title:** Change From Baseline in Total Urogenital Symptom Score, Week 8, ITT Population
**Type:** SECONDARY
**Unit of Measure:** Change in Score
##### Group
**Description:** 1 tablet daily containing 0.9 mg estradiol acetate
**ID:** OG000
**Title:** Estradiol Acetate (E3A)
##### Group
**Description:** 1 tablet daily containing 1 mg estradiol
**ID:** OG001
**Title:** Estradiol
##### Group
**Description:** 1 tablet daily containing 0.625 mg conjugated equine estrogen
**ID:** OG002
**Title:** Conjugated Equine Estrogens (CEE)
#### Outcome Measure 7
**Description:** Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)
**Reporting Status:** POSTED
**Time Frame:** Baseline to Week 12
**Title:** Change From Baseline in Total Urogenital Symptom Score, Week 12, ITT Population
**Type:** SECONDARY
**Unit of Measure:** Change in Score
##### Group
**Description:** 1 tablet daily containing 0.9 mg estradiol acetate
**ID:** OG000
**Title:** Estradiol Acetate (E3A)
##### Group
**Description:** 1 tablet daily containing 1 mg estradiol
**ID:** OG001
**Title:** Estradiol
##### Group
**Description:** 1 tablet daily containing 0.625 mg conjugated equine estrogen
**ID:** OG002
**Title:** Conjugated Equine Estrogens (CEE)
### Participant Flow Module
#### Group
**Description:** 1 tablet daily containing 0.9 mg estradiol acetate
**ID:** FG000
**Title:** Estradiol Acetate (E3A)
#### Group
**Description:** 1 tablet daily containing 1 mg estradiol
**ID:** FG001
**Title:** Estradiol
#### Group
**Description:** 1 tablet daily containing 0.625 mg conjugated equine estrogen
**ID:** FG002
**Title:** Conjugated Equine Estrogens (CEE)
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
###### Reason
**Group ID:** FG002
**Number of Subjects:** 3
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
###### Reason
**Group ID:** FG002
**Number of Subjects:** 6
##### Withdraw
**Type:** Surgery, moving, personal, abn. labs
###### Reason
**Group ID:** FG000
**Number of Subjects:** 4
###### Reason
**Group ID:** FG001
**Number of Subjects:** 4
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
##### Withdraw
**Type:** No study drug taken
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 79
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 85
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 85
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 68
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 73
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 72
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 11
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 12
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 13
**Pre-Assignment Details:** Discontinue estrogen/hormone therapy prior to enrollment
**Recruitment Details:** Enrollment of postmenopausal women for relief of hot flushes and urogenital symptoms beginning Feb '03 at 33 sites in the US.
**Has Results:** True