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

Rockefeller University

Status and phase

Completed

Early Phase 1

Conditions

Obesity

Treatments

Drug: Celebrex

Study type

Interventional

Funder types

Other

Identifiers

NCT01901679

PHO-0807

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

Female

Ages

40 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.