Metabolic Syndrome in PCOS: Precursors and Interventions

Northwestern University

Status: Completed

Conditions: Polycystic Ovary Syndrome; Metabolic Syndrome

Treatments: Drug: ethinyl estradiol 35 mcg and drospirenone 3 mg; Drug: flutamide; Other: placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00442689

R01DK073411 (U.S. NIH Grant/Contract)

DK73411

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 97 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

97 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

oral contraceptive (35 mg ethinyl estradiol)

Treatment:

Drug: ethinyl estradiol 35 mcg and drospirenone 3 mg

2

Experimental group

Description:

Flutamide 250 mg twice daily

Treatment:

Drug: flutamide

3

Placebo Comparator group

Description:

Placebo

Treatment:

Other: placebo