## Protocol Section
### Identification Module
**NCT ID:** NCT01901679

**Brief Title:** Celecoxib Inhibition of Aromatase Expression and Inflammation in Adipose Tissue of Obese Postmenopausal Women

**Official Title:** A Pilot Study: Celecoxib Inhibition of Aromatase Expression and Inflammation in Adipose Tissue of Obese Postmenopausal Women

#### Organization Study ID Info
**ID:** PHO-0807
#### Organization
**Class:** OTHER
**Full Name:** Rockefeller University
### Status Module
#### Completion Date
**Date:** 2014-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-02-01

**Type:** ACTUAL

**Last Update Submit Date:** 2021-01-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-08

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2021-02-01

**Type:** ACTUAL

**Results First Submit Date:** 2020-11-13

**Results First Submit QC Date:** 2021-01-28

#### Start Date
**Date:** 2013-07

**Status Verified Date:** 2021-01

#### Study First Post Date
**Date:** 2013-07-17
**Type:** ESTIMATED
**Study First Submit Date:** 2013-07-10
**Study First Submit QC Date:** 2013-07-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Rockefeller University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The study plans to find out whether Celebrex may be potentially useful to decrease inflammation in fat tissues and thereby lower the production of substances such as estrogens that may increase the risk of developing breast cancer and lead to a poor outcome of the disease.

**Detailed Description:** This study seeks to examine how effective the celebrex may be in reducing inflammation, crown-like structures in fat tissue, the enzyme aromatase, PGE-M in the urine and estrogen in blood and urine. Volunteer subjects will be expected to stay in the hospital for about 2 weeks taking Celebrex for approximately 10 days while eating a diet similar to what they consumed before coming into the hospital for the study.

### Conditions Module

**Conditions:**

- Obesity

**Keywords:**

- Obesity

- Post-menopausal

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 10

**Type:** ACTUAL

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 10 days treatment with Celebrex to evaluate reduction of PGE-M in urine

**Intervention Names:**

- Drug: Celebrex

**Label:** Celebrex

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Celebrex

**Description:** 200 mg PO BID

**Name:** Celebrex

**Other Names:**

- Celecoxib

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Study endpoint is a reduction in PGE-M in urine after treatment with celebrex

**Measure:** To Determine Whether Oral Administration of Celebrex to Obese Women Will Reduce the PGE-M in Urine

**Time Frame:** 10 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Postmenopausal woman defined as: 24 consecutive months without a menstrual period and currently not taking any medication known to induce amenorrhea.
* Serum estradiol \< 20 pg/mL
* Body Mass Index of 35-50
* Stable weight defined as (+/- 5 %) of body weight for at least three months
* 40-70 years of age
* Fluent in English

Exclusion Criteria:

* Known hypersensitivity to celecoxib or sulfonamides
* Known peptic ulcer disease
* Hypertension BP \> 150/90 (on 2 occasions after resting)
* Fasting blood glucose \> 165 mg/dL
* HIV positive
* Screening creatinine \> 2X upper limit of normal
* Screening LFT results \> 2x upper limit of normal
* Smokers (or stopped \< 3 months ago)
* Framingham risk score \> 15
* Evidence of active coronary disease by history and/or EKG
* Subjects who consume 25 grams of soy protein/day or more than 45 mg of isoflavones/day, for subjects who consume this amount of soy, they may stop for 14 days prior to admission
* Currently taking NSAIDS, aspirin, (if \> once a week, stopped \<30 days ago).
* Consuming \> 3 servings of fish or seafood/week
* Currently taking fish oil, omega-3 supplements or other herbal supplements that exceed GRAS (Generally Recognized as Safe) levels, (if currently taking fish oil/omega-3 supplements, there must be a 30 day washout period)
* Current use of anti-coagulants
* Currently taking any weight control medication
* Currently taking thioridazine
* Currently taking lithium
* Currently taking any estrogen/progesterone hormones including vaginal cream, e-string, or vaginal tablets
* Currently taking any medication that can alter fat stores as determined by the principal investigator
* History of Inflammatory Bowel Disease or other chronic inflammatory disorders
* History of any malignancy other than non-melanoma skin cancer in the past 5 years
* History of any bleeding disorder
* History of cardiovascular disease
* Diagnosis of asthma
* Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data.

**Healthy Volunteers:** True

**Maximum Age:** 70 Years

**Minimum Age:** 40 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New York

**Country:** United States

**Facility:** The Rockefeller University

**State:** New York

**Zip:** 10065

#### Overall Officials

**Official 1:**

**Affiliation:** Rockefeller University

**Name:** Peter Holt, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Document Section

### Large Document Module

#### Large Docs

- Date: 2017-12-12

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 5033702

- Type Abbrev: Prot_SAP

- Upload Date: 2020-09-29T15:17

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M10293

- Name: Inflammation

- Relevance: HIGH

- As Found: Inflammation

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: T6036

- Name: Menopause

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007249

- Term: Inflammation

### Intervention Browse Module - Ancestors

- ID: D000000894

- Term: Anti-Inflammatory Agents, Non-Steroidal

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000052246

- Term: Cyclooxygenase 2 Inhibitors

- ID: D000016861

- Term: Cyclooxygenase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M277

- Name: Celecoxib

- Relevance: HIGH

- As Found: Air

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4218

- Name: Anti-Inflammatory Agents, Non-Steroidal

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M27009

- Name: Cyclooxygenase 2 Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M19209

- Name: Cyclooxygenase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000068579

- Term: Celecoxib

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** AE's were reported when discovered. Reports were from investigator assessment, nursing assessment and patient complaints. All AE's were documented and submitted to the IRBand PI as per protocol.

#### Event Groups

**Group ID:** EG000

**Title:** 1st Group: 3 Day run-in Period

**Deaths Num At Risk:** 5

**Description:** After 3 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge.

**ID:** EG000

**Other Num Affected:** 2

**Other Num at Risk:** 5

**Serious Number Affected:** 1

**Serious Number At Risk:** 5

**Title:** 1st Group: 3 Day run-in Period

**Group ID:** EG001

**Title:** 2nd Group: 14 Day run-in Period

**Deaths Num At Risk:** 5

**Description:** After 14 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge.

**ID:** EG001

**Other Num Affected:** 4

**Other Num at Risk:** 5

**Serious Number At Risk:** 5

**Title:** 2nd Group: 14 Day run-in Period

**Frequency Threshold:** 0

#### Other Events

**Term:** bruise at biopsy site

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Due to the pinching of abdominal fat during the fat biopsy, a resultant bruise medial to the incision is common and expected. It resolved within 3-4 days and well tolerated. The risk is addressed in the informed consent.

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** CTCAE (4.0)

**Term:** burn

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Participant spilled hot tea on her chest wall resulting in 1st degree scald burn of her upper chest.

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** atypical chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Subject complained of chest pain after burning her skin with hot tea.

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** elevated serum cholesterol

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Subjet had history of hypercholesteremia. She stopped taking statin medication prescribed by PMD. Cholesterol level increased. PMD was informed and given test results.

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (4.0)

**Term:** elevated ALT

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** After 10 days on celecoxib, subject had mild elevation in ALT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (4.0)

**Term:** GI Bloating and constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Subject complained of bloating and constipation.

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** sore throat and dry cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Subject complained of sore throat and dry cough after a group gathering. Afebrile.

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** CTCAE (4.0)

#### Serious Events

**Term:** hemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** During abdominal fat biopsy procedure, there was moderate bleeding from the site. Procedure was stopped, and the bleeding ceased. Subject was stable and recovered promptly, but was monitored for an additional day for safety.

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** CTCAE (4.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 5

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 5

**Time Frame:** Collected during inpatient phase of study, an average of 14 days for 3 day run-in period or 24 days for 14 day run-in period

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 5

**Group ID:** BG001

**Value:** 5

**Group ID:** BG002

**Value:** 10

**Units:** Participants

### Group

**ID:** BG000

**Title:** 3 Day run-in Period

**Description:** After 3 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge.

### Group

**ID:** BG001

**Title:** 14 Day run-in Period

**Description:** After 14 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 56

**Upper Limit:** 68

**Value:** 62

#### Measurement

**Group ID:** BG001

**Lower Limit:** 53

**Upper Limit:** 60

**Value:** 56

#### Measurement

**Group ID:** BG002

**Lower Limit:** 53

**Upper Limit:** 68

**Value:** 59

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 10

**Class Title:** Female

### 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:** 3

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 7

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 3

**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:** 5

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 10

**Class Title:** United States

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 38.2

**Upper Limit:** 43.1

**Value:** 40.2

#### Measurement

**Group ID:** BG001

**Lower Limit:** 36.7

**Upper Limit:** 45.1

**Value:** 39.7

#### Measurement

**Group ID:** BG002

**Lower Limit:** 36.7

**Upper Limit:** 45.1

**Value:** 40.0

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** NUMBER
**Title:** Sex/Gender, Customized
**Unit of Measure:** participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 5
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEAN
**Title:** BMI
**Unit of Measure:** kg/m^2
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** holtp@rockefeller.edu
**Organization:** The Rockefeller University
**Phone:** 212-327-7706
**Title:** Dr. Peter R Holt
## Results Section - Outcome Measures Module
### Outcome Measure 1
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Study endpoint is a reduction in PGE-M in urine after treatment with celebrex
**Population Description:** These samples were collected but not analyzed due to technical reasons. Investigator has retired and access to results was not available for this outcome. Best efforts were made to obtain the data; however, they were unsuccessful.
**Reporting Status:** POSTED
**Time Frame:** 10 days
**Title:** To Determine Whether Oral Administration of Celebrex to Obese Women Will Reduce the PGE-M in Urine
**Type:** PRIMARY
##### Group
**Description:** After 3 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge.
**ID:** OG000
**Title:** 1st Group: 3 Day run-in Period
##### Group
**Description:** After 14 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge.
**ID:** OG001
**Title:** 2nd Group: 14 Day run-in Period
### Participant Flow Module
#### Group
**Description:** After 3 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge.
**ID:** FG000
**Title:** 1st Group: 3 Day run-in Period
#### Group
**Description:** After 14 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge.
**ID:** FG001
**Title:** 2nd Group: 14 Day run-in Period
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 5
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 5
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Pre-Assignment Details:** All participants were screened for their usual dietary intake and instructed to continue to follow their usual diet during weeks prior to hospital admission and thoughout the entire study. .

First group underwent 3 day run-in period inpatient, the second group underwent 14 day run-in period prior to starting Celecoxib 200mg po BID X 10 days.
**Recruitment Details:** Recruitment was conducted during 2 outpatient visits at Rockefeller University Hospital outpatient clinic. Recruitment of subjects began on 6/10/13 and was completed on 6/30/14.
**Has Results:** True