Skip to main content
OpenTrials
Completed

NCT Number: NCT00442689

Metabolic Syndrome in PCOS: Precursors and Interventions

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Body Weight Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Infertility Insulin Resistance Metabolic Diseases Metabolic Syndrome Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

flutamide

Drug

250 mg twice daily

Other names: Eulexin

ethinyl estradiol 35 mcg and drospirenone 3 mg

Drug

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

Other names: Yasmin

Placebo

Other

Other names: sugar pill

Primary outcomes

  1. Change in Low-density Lipoprotein (LDL) Levels Over the Study Period

    Time frame: 6 months

    Change in low-density lipoprotein (LDL) levels over the study period (LDL level at study endpoint - baseline LDL level)

  2. Change in High-density Lipoprotein (HDL) Levels During Study Period

    Time frame: 6 months

    Change in high-density lipoprotein (HDL) levels during study period (HDL level at study endpoint - baseline HDL)

  3. Change in Visceral Adipose Tissue (VAT) Volume as Measured by MRI

    Time frame: 6 months

    Change in visceral adipose tissue (VAT) volume as measured by MRI (VAT at study endpoint - baseline VAT)

  4. Change in Fat Percentage as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan Over the Study Period

    Time frame: 6 months

    Change in fat percentage as measured by DEXA scan over the study period (Fat percentage at study endpoint - baseline fat percentage)

  5. Change in Disposition Index

    Time frame: 6 months

    Change in disposition index (DI, insulin secretion corrected for insulin secretion) as measured by frequently-sampled IV glucose tolerance test (DI at study endpoint - baseline DI)

  6. Change in Resting Energy Expenditure (REE) Over the Study Period

    Time frame: 6 months

    Change in resting energy expenditure (REE) over the study period (REE at study endpoint - baseline REE)

  7. Change in Maximal Aerobic Exercise Capacity (VO2 Max) Over the Study Period

    Time frame: 6 months

    Change in maximal aerobic exercise capacity (VO2 max) over the study period (VO2 max at study endpoint - baseline VO2 max)

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Mar 2, 2007
Registry last updated
Jun 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.