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Celecoxib Inhibition of Aromatase Expression and Inflammation in Adipose Tissue of Obese Postmenopausal Women

Information source: Rockefeller University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obesity

Intervention: Celebrex (Drug)

Phase: Phase 0

Status: Completed

Sponsored by: Rockefeller University

Official(s) and/or principal investigator(s):
Peter Holt, MD, Principal Investigator, Affiliation: Rockefeller University


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.

Clinical Details

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

Study design: Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: To determine whether oral administration of Celebrex to obese women will reduce the PGE-M in urine

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.


Minimum age: 40 Years. Maximum age: 70 Years. Gender(s): Female.


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.

Locations and Contacts

The Rockefeller University, New York, New York 10065, United States
Additional Information

Starting date: July 2013
Last updated: November 4, 2014

Page last updated: August 20, 2015

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