Status:
COMPLETED
Androgen Excess as a Cause for Adipogenic Dysfunction in PCOS Women
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Oregon Health and Science University
Conditions:
Polycystic Ovary Syndrome (PCOS)
Eligibility:
FEMALE
18-35 years
Phase:
PHASE2
Brief Summary
The purpose of this research study is to collect specimen samples and study medical information from women with Polycystic Ovary Syndrome (PCOS) and women without PCOS. The goal is to learn more about...
Detailed Description
Aim 1. Examine mechanisms of subcutaneous abdominal adipose (fat) development in normal-weight PCOS women vs. BMI- and age-matched normal (control) women. Subjects and clinical assessment: We will re...
Eligibility Criteria
Inclusion
- Women between the ages of 18 to 35 years.
- Groups will be: 16 lean controls and 16 age- and BMI-matched PCOS women randomized to flutamide vs. placebo for 6 months.
- i) Lean patients with PCOS: 16 subjects with PCOS (defined by 1990 NIH criteria \[all Aims\]), BMI 18.5-25 kg/m2. This BMI range is defined as normal and has been chosen to examine underlying mechanisms of PCOS-related androgen excess in the genesis of adipogenic and ovarian dysfunction, independent of obesity.
- ii) Lean control women: 16 healthy subjects, BMI 18.5-25 kg/m2. Controls will have regular menstrual cycles, and no evidence of hirsutism, acne, alopecia, polycystic ovaries, and/or endocrine dysfunction. This BMI range has been chosen to match that of the PCOS group.
Exclusion
- Exclusion criteria for study participation are: present or past history (\<1 years) of smoking, cancer, alcohol abuse, drug addiction, severe depression, or post traumatic stress; diabetes; uncontrolled hypertension (≥ 165/100); clinically significant hepatic or renal disease, or other major medical illness; recent (within 3 months) use of androgens, anabolic steroids or hormonal agents (including birth control pills or insulin sensitizers). These exclusion criteria are chosen to avoid effects from medical conditions, environmental factors or exogenous agents. Women taking the drug warfarin, CYP active medications, or herbs will be excluded.
- The screener will assess the participants response to establish if depression or drug use exclude participation in this study.
- Women taking beta blockers will be excluded.
- Women who have taken birth control pills or had a Mirena IUD or used Plan B contraception during the previous 3 months will be excluded.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2023
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01889199
Start Date
April 1 2013
End Date
July 6 2023
Last Update
January 10 2025
Active Locations (1)
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1
UCaliforniaLA
Los Angeles, California, United States, 90095-1740