Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Gland and Hormone Related Diseases

Overweight

Syndrome

Infertility

Polycystic Ovary Syndrome

Insulin Resistance

Metabolic Syndrome

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Natriuretic Agents

Reproductive Control Agents

Antineoplastic Agents

Insulin

Insulin, Globin Zinc

Drospirenone

Ethinyl Estradiol

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Estradiol

Polyestradiol phosphate

Contraceptive Agents

Drospirenone and ethinyl estradiol combination

Contraceptives, Oral

Flutamide

Estrogens

Hormones

Hormone Antagonists

Contraceptive Agents, Hormonal

Contraceptive Agents, Female

Contraceptives, Oral, Hormonal

Mineralocorticoid Receptor Antagonists

Mineralocorticoids

Diuretics

Diuretics, Potassium Sparing

Androgens

Androgen Antagonists

Antineoplastic Agents, Hormonal

oral contraceptive (35 mg ethinyl estradiol)

flutamide

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

ethinyl estradiol 35 mcg and drospirenone 3 mg

placebo

Andrea Dunaif, MD

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.

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.

Metabolic Syndrome in PCOS: Precursors and Interventions

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

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

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

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

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)

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

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

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

Northwestern University

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

Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)

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

Oral Contraceptive - 1

Flutamide - 2

Placebo - 3

Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)

Total

Age, Continuous

Sex: Female, Male

Body mass index (kg/m^2)

Please note there were 2 additional arms at the start of the study: Metformin alone (n=8) and Metformin+Flutamide (n=6), which were discontinued. These arms are therefore not included in these results data.

Dr. Laura Torchen

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

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

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

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

Change in Disposition Index

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

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

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Metabolic Syndrome in PCOS: Precursors and Interventions	NCT00442689	Polycystic Ovar... Metabolic Syndr...	flutamide ethinyl estradi... placebo	18 Years - 35 Years	Northwestern University
Metabolic Syndrome in PCOS: Precursors and Interventions	NCT00442689	Polycystic Ovar... Metabolic Syndr...	flutamide ethinyl estradi... placebo	18 Years - 35 Years	Northwestern University

Spots Global Cancer Trial Database for ethinyl estradiol 35 mcg and drospirenone 3 mg