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

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ClinicalTrials.gov Identifier: NCT01901679
Recruitment Status : Completed
First Posted : July 17, 2013
Last Update Posted : November 6, 2014
Sponsor:
Information provided by (Responsible Party):
Rockefeller University

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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Celebrex Early Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Pilot Study: Celecoxib Inhibition of Aromatase Expression and Inflammation in Adipose Tissue of Obese Postmenopausal Women
Study Start Date : July 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Arm Intervention/treatment
Experimental: Celebrex
10 days treatment with Celebrex to evaluate reduction of PGE-M in urine
Drug: Celebrex
200 mg PO BID
Other Name: Celecoxib




Primary Outcome Measures :
  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



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01901679


Locations
United States, New York
The Rockefeller University
New York, New York, United States, 10065
Sponsors and Collaborators
Rockefeller University
Investigators
Principal Investigator: Peter Holt, MD Rockefeller University

Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT01901679     History of Changes
Other Study ID Numbers: PHO-0807
First Posted: July 17, 2013    Key Record Dates
Last Update Posted: November 6, 2014
Last Verified: November 2014

Keywords provided by Rockefeller University:
Obesity
Post-menopausal

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents