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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00442689 |
The purpose of this study is to determine whether lowering insulin levels using a medication called metformin, and blocking the action of male hormones with the medication flutamide wil decrease central body fat, improve cholesterol levels or affect sugar handling in women with PCOS (Polycystic ovary syndrome) The effects of these medications will be compared to the effects of the oral contraceptive pill (OCP), Yasmin.
Condition | Intervention |
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Polycystic Ovary Syndrome Metabolic Syndrome |
Drug: Metformin Drug: flutamide Drug: drospirenone Other: placebo |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Metabolic Syndrome in PCOS: Precursors and Interventions |
Estimated Enrollment: | 200 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
oral contraceptive (drospirenone) plus placebo
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Drug: drospirenone
one active pill per day for three weeks and then 1 sugar pill per day for one week
Other: placebo
1-3 per day for the first week and then 1-4 per day for the rest of the six month study period. Subjects may receive only placebo (arm 5) or placebo in addition to the drug(s) they receive.
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2: Experimental
Metformin plus placebo
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Drug: Metformin
850mg tablets, 1 tablet/day with food for one week. After one week, subjects will take 1 tablet twice a day with food for the rest of the sixth month study period.
Other: placebo
1-3 per day for the first week and then 1-4 per day for the rest of the six month study period. Subjects may receive only placebo (arm 5) or placebo in addition to the drug(s) they receive.
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3: Experimental
Flutamide plus placebo
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Drug: flutamide
250 mg twice daily
Other: placebo
1-3 per day for the first week and then 1-4 per day for the rest of the six month study period. Subjects may receive only placebo (arm 5) or placebo in addition to the drug(s) they receive.
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4: Experimental
Metformin and Flutamide plus placebo
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Drug: Metformin
850mg tablets, 1 tablet/day with food for one week. After one week, subjects will take 1 tablet twice a day with food for the rest of the sixth month study period.
Drug: flutamide
250 mg twice daily
Other: placebo
1-3 per day for the first week and then 1-4 per day for the rest of the six month study period. Subjects may receive only placebo (arm 5) or placebo in addition to the drug(s) they receive.
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5: Placebo Comparator
Placebo only
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Other: placebo
1-3 per day for the first week and then 1-4 per day for the rest of the six month study period. Subjects may receive only placebo (arm 5) or placebo in addition to the drug(s) they receive.
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Polycystic ovary syndrome (PCOS) is one of the most common conditions of young women, and it is frequently associated with insulin resistance or metabolic syndrome (MBS). In addition, affected women have significantly elevated mean LDL levels and an increased prevalence of at risk LDL levels, independent of obesity. There is a genetic susceptibility to PCOS and we have identified a major susceptibility gene or genetic element on chromosome 19p3.2 near the insulin receptor gene that is linked and associated with the reproductive phenotype of hyperandrogenemia. We have mapped the location of this variant (allele 8[A8]D19S884)to an allele a dinucleotide repeat in intron 55 of the fibrillin 3 gene. We are directly testing the role of androgens in the metabolic abnormalities in PCOS by examining the impact of androgen receptor blockade, alone and in combination with insulin sensitization, on visceral adiposity and circulating LDL levels. Further, we will determine whether A8 is associated with differential responses to this intervention. We will use the pure antiandrogen, flutamide, and the insulin-sensitizing agent, metformin. In short term studies, OCP(oral contraceptive pill) decreased insulin sensitivity in women with PCOS. We have included a standard therapy arm with diet and the OCP, Yasmin, order to assess its impact on metabolic endpoints concurrently with the othe interventions so that the data will be directly comparable.
Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Andrea Dunaif, MD | 312-503-2902 | a-dunaif@northwestern.edu |
Contact: Olga Cardenas, MD | 312-503-4385 | m-cardenas@md.northwestern.edu |
United States, Illinois | |
Northwestern Memorial Hospital | Recruiting |
Chicago, Illinois, United States, 60611 | |
Principal Investigator: Andrea Dunaif, MD |
Principal Investigator: | Andrea Dunaif, MD | Northwestern University |
Responsible Party: | Northwestern University ( Andrea Dunaif ) |
Study ID Numbers: | DK73411 |
Study First Received: | February 5, 2007 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00442689 |
Health Authority: | United States: Food and Drug Administration |
Polycystic Ovary Syndrome Metabolic Syndrome PCOS overweight |
infertility Insulin Resistance menstrual cycle |
Infertility Gonadal Disorders Metformin Endocrine System Diseases Overweight Ovarian Diseases Cysts Flutamide |
Insulin Genital Diseases, Female Polycystic Ovary Syndrome Drospirenone Insulin Resistance Endocrinopathy Ovarian Cysts |
Neoplasms Pathologic Processes Disease Aldosterone Antagonists Hormone Antagonists |
Syndrome Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions Adnexal Diseases |