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

NCT01901679 | Completed Early Phase 1 Results

• 1 other identifier: PHO-0807
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; Post-menopausal

Outcome Measures

Primary Outcomes (1)

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

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

  10 days

Study Arms (1)

Celebrex

EXPERIMENTAL

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

Drug: Celebrex

Interventions

Celebrex DRUG

200 mg PO BID

Also known as: Celecoxib

Celebrex

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age
• Fluent in English

You may not qualify if:

• 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

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

The Rockefeller University

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Peter R Holt
• Organization: The Rockefeller University

holtp@rockefeller.edu

212-327-7706

Study Officials

• Peter Holt, MD

  Rockefeller University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2013
• First Posted: July 17, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 1, 2021
• Results First Posted: February 1, 2021

Record last verified: 2021-01

Locations

US (1)