Metabolic Syndrome in PCOS: Precursors and Interventions

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2012-11-30

Brief Summary

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The purpose of this study is to investigate the metabolic effects of anti-androgens and oral contraceptive pills (OCPs), compared with placebo, in the treatment of women with PCOS. We hypothesized that controlling elevated androgen levels with either anti-androgens or OCPs would produce improvement in metabolic markers in PCOS women and would reduce their long term metabolic risk.

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Detailed Description

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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 low-density lipoprotein (LDL) levels and an increased prevalence of at risk LDL levels, independent of obesity. We are directly testing the role of androgens in the metabolic abnormalities in PCOS by examining the impact of direct androgen receptor blockade by anti-androgen medications and indirect suppression of androgen production through suppression of leutinizing hormone (LH) with oral contraceptive pills (OCPs), compared with placebo, on visceral adiposity, circulating LDL levels, insulin secretion and sensitivity as measured by frequently-sampled IV glucose tolerance tests (FSIGT) and oral glucose tolerance tests (OGTT), resting energy expenditure, and maximal aerobic capacity measurement.

Note: Originally there were 2 additional study arm, Metformin only and Metformin + Flutamide. These study arms were ultimately eliminated and were not included in analysis of baseline characteristics or endpoints.

Conditions

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Polycystic Ovary Syndrome Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

oral contraceptive (35 mg ethinyl estradiol)

Group Type EXPERIMENTAL

ethinyl estradiol 35 mcg and drospirenone 3 mg

Intervention Type DRUG

one active pill per day for three weeks and then 1 sugar pill per day for one week

2

Flutamide 250 mg twice daily

Group Type EXPERIMENTAL

flutamide

Intervention Type DRUG

250 mg twice daily

3

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Interventions

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flutamide

250 mg twice daily

Intervention Type DRUG

ethinyl estradiol 35 mcg and drospirenone 3 mg

one active pill per day for three weeks and then 1 sugar pill per day for one week

Intervention Type DRUG

placebo

Intervention Type OTHER

Other Intervention Names

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Eulexin Yasmin sugar pill

Eligibility Criteria

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Inclusion Criteria

* 6 periods or fewer per year
* Overweight
* All ethnicities

Exclusion Criteria

* Diabetes
* Heart Disease
* Chronic illness
* Regular Smokers
* Current use of Birth Control Pills, Patch, Ring, Depo

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Andrea Dunaif

Charles F Kettering Professor of Endocrinology & Metabolism Vice Chair for Research, Department of Medicine Northwestern University, Feinberg School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR