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OpenTrials
Completed

NCT Number: NCT01901679

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

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.

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Key information

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

The Rockefeller University

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Celebrex

Drug

200 mg PO BID

Other names: Celecoxib

Primary outcomes

  1. To Determine Whether Oral Administration of Celebrex to Obese Women Will Reduce the PGE-M in Urine

    Time frame: 10 days

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

Sponsors and collaborators

Lead sponsor

Rockefeller University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 17, 2013
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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