Androgen Excess as a Cause for Adipogenic Dysfunction in PCOS Women
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ClinicalTrials.gov Identifier: NCT01889199 |
Recruitment Status :
Recruiting
First Posted : June 28, 2013
Last Update Posted : May 18, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
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Polycystic Ovary Syndrome (PCOS) | Drug: Flutamide Other: Placebo | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 32 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Androgen Excess as a Cause for Adipogenic Dysfunction in PCOS Women |
Study Start Date : | April 2013 |
Estimated Primary Completion Date : | April 1, 2023 |
Estimated Study Completion Date : | April 1, 2023 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Sugar pill
Placebo intervention
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Other: Placebo
Placebo orally each 28 day cycle for 6 cycles |
Experimental: Flutamide
Flutamide 125 mg orally daily for six 28-day cycles.
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Drug: Flutamide
Flutamide 125 mg orally each 28 day cycle for 6 cycles
Other Name: Euflex |
- Six-month flutamide (antiandrogen) administration to lean women with polycystic ovary syndrome (PCOS) will improve impaired glucose tolerance by glucose tolerance testing and normalize subcutaneous (SC) fat cells by fat biopsy. [ Time Frame: 6 months ]Women with PCOS exhibit impaired glucose tolerance that correlates with abnormal subcutaneous (SC) abdominal adipocytes. Since a common denominator to these abnormalities is hyperandrogenism, we hypothesize that 6-month flutamide (antiandrogen) administration to lean PCOS women will improve glucose tolerance by glucose tolerance testing and normalize subcutaneous (SC) abdominal adipocytes, as determined by SC abdominal fat biopsy.
- Quality of Life Questionnaires [ Time Frame: 6 months ]
- Liver transaminases (serum glutamic oxaloacetic transaminase [SGOT]; serum glutamic-pyruvic transaminase [SGPT]) [ Time Frame: 6 months ]This study carefully considers the safety of low-dose flutamide in examining how hyperandrogenism in PCOS affects ovarian function, subcutaneous fat storage and glucose metabolism. The 125 mg oral dose of flutamide has been specifically chosen because it has not been associated with liver enzyme abnormalities (0%, 62.5-125 mg/day), while being as effective as high dose flutamide in improving androgenic symptoms. Furthermore, in the rare event mild elevation of hepatic enzymes occurs with low-dose flutamide despite its dose-dependency, it is easily detected and reversible.

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Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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.

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): NCT01889199
Contact: Daniel A Dumesic, MD | (310) 794-5542 | DDumesic@mednet.ucla.edu | |
Contact: Andrea Rapkin, MD | (310) 825-6301 | ARapkin@mednet.ucla.edu |
United States, California | |
UCaliforniaLA | Recruiting |
Los Angeles, California, United States, 90095-1740 | |
Contact: Daniel A Dumesic, MD 310-794-5542 DDumesic@mednet.ucla.edu | |
Contact: Rapkin Andrea, MD (310) 825-6301 ARapkin@mednet.ucla.edu |
Principal Investigator: | Daniel Dumesic, MD | University of California, Los Angeles |
Responsible Party: | Daniel A. Dumesic, MD, Professor, Division of Reproductive Endocrinology and Infertility, University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT01889199 |
Other Study ID Numbers: |
UCLA IRB #12-001780 |
First Posted: | June 28, 2013 Key Record Dates |
Last Update Posted: | May 18, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
polycystic ovary syndrome hirsutism anovulation oligomenorrhea |
amenorrhea hyperandrogenism antiandrogen effect |
Polycystic Ovary Syndrome Hyperandrogenism Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases 46, XX Disorders of Sex Development Disorders of Sex Development |
Urogenital Abnormalities Adrenogenital Syndrome Congenital Abnormalities Flutamide Androgen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents |