Phase 2 N=23 Randomized Triple-blind Treatment

Androgen Excess as a Cause for Adipogenic Dysfunction in PCOS Women

Polycystic Ovary Syndrome (PCOS)

Bottom Line

View on ClinicalTrials.gov: NCT01889199 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcome: Primary: Lipid Content of PCOS Subcutaneous (SC) Abdominal Adipocytes Matured in Vitro. — 2.0; 5.6; 1.37; 3.8 fluorescence units/cell number — p=0.004

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Flutamide (Drug); Placebo (Other)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: University of California, Los Angeles
Primary completion: Jul 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Lipid Content of PCOS Subcutaneous (SC) Abdominal Adipocytes Matured in Vitro.	2.0; 5.6; 1.37; 3.8; -0.6; -1.8	0.004 sig
SECONDARY Fasting Glucose Levels	85.6; 83.9; 85.8; 85.3; 88.6; -0.3	—
SECONDARY Depression as Assessed by Beck Depression Inventory (BDI)	0; 0	—
SECONDARY Percent Android Fat Mass	6.0; 6.1; 5.5; 6.4; 5.9; 0.4	0.040 sig
SECONDARY Fasting Serum Lipoprotein Levels	1.9; 1.7; 1.7; 1.9; 1.7; 0.0	0.034 sig
SECONDARY Fasting Serum Total Cholesterol	153.7; 184.0; 153.0; 155.3; 168.0; 1.7	—

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 the changes that take place in the body that result in PCOS. We anticipate that 32 women will take part in this study (16 without PCOS and 16 with PCOS). All patients will undergo a physical exam, blood tests, and ultrasound of their ovaries. If they meet the criteria for this study, they will then undergo additional blood tests, removal of a small amount of subcutaneous abdominal fat, measurement of regional body fat (i.e., DXA scan) and a modified frequently-sampled intravenous glucose tolerance test (FSIGTT). The women without PCOS will complete the study at this point. The women with PCOS will be randomized to receive the drug flutamide 125 mg/day or placebo. They will take the drug every day for six 28-day cycles. They will be asked to collect and store a urine sample once a week. They will also be asked to complete a pill diary and menstrual diary. Once a month while they are taking the flutamide/placebo, they will return to the clinic and bring their frozen urine samples. At that time they will undergo a physical exam, toxicity assessment, and blood draw. Quality of Life assessments will be done at the beginning of the study for all participants. Women with PCOS who are taking the flutamide or placebo will be asked to repeat the Quality of Life assessments during the study and at the end of the study. After the six 28-day cycles are completed they will then undergo additional blood tests, removal of a small amount of subcutaneous abdominal fat, measurement of regional body fat (i.e., DXA scan) and a modified frequently-sampled intravenous glucose tolerance test (FSIGTT). Six months following the completion of all study protocol procedures, participants who received flutamide/placebo will be contacted by phone to check on the status of their health. They will be asked if they have experienced any health problems or have become pregnant since they completed the study procedures.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01889199). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.