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

NCT ID: NCT01901679

Last Updated: 2021-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-08-31

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

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Celebrex

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

Group Type: EXPERIMENTAL

Celebrex

Intervention Type: DRUG

200 mg PO BID

Interventions

Celebrex

200 mg PO BID

Intervention Type: DRUG

Other Intervention Names

Celecoxib

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Rockefeller University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Holt, MD

Role: PRINCIPAL_INVESTIGATOR

Rockefeller University

Locations

The Rockefeller University

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PHO-0807

Identifier Type: -

Identifier Source: org_study_id