The Impact of Metformin, Oral Contraceptives and Lifestyle Modification, on Polycystic Ovary Syndrome in Obese Adolescent Women in Two Randomized, Placebo-Controlled Clinical Trials.

Author(s): Hoeger K, Davidson K, Kochman L, Cherry T, Kopin L, Guzick DS

Affiliation(s): Departments of Obstetrics and Gynecology (KMH, LK, DSG), Cardiology (TC, LK) and Psychiatry (KD), University of Rochester Medical Center, Rochester, NY 14642.

Publication date & source: 2008-08-26, J Clin Endocrinol Metab., [Epub ahead of print]

Publication type:

Context: Polycystic ovary syndrome (PCOS) presents in adolescence and obesity is a common finding. The benefits and risks of alternate approaches to the management of PCOS in obese adolescent women are not clear. Objective: We investigated the effects of metformin, oral contraceptive and/or lifestyle modification in obese adolescent women with PCOS. Design: Two randomized, placebo-controlled small clinical trials Patients and Participants: 79 obese adolescent women with PCOS Interventions: In the Single Treatment Trial, subjects were randomized to metformin, placebo, a lifestyle modification program or oral contraceptive. In the Combined Treatment Trial, all subjects received lifestyle modification and oral contraceptive (OC) and were randomized to metformin or placebo. Main outcome measures: Serum concentrations of androgens and lipids. Results: Lifestyle modification alone resulted in a 59% reduction in free androgen index (FAI) with a 122% increase in sex hormone binding globulin (SHBG). OC resulted in significant decrease in total testosterone (44%) and FAI (86%), but also resulted in an increase in C-reactive protein (CRP) (39.7%) and cholesterol (14%). The combination of lifestyle modification, OC and metformin resulted in a 55% decrease in total testosterone, as compared to 33% with combined treatment and placebo, a 4% reduction in waist circumference, and a significant increase in HDL (46%). Conclusions: In these preliminary trials both lifestyle modification and oral contraceptives significantly reduce androgens and increase SHBG in obese adolescents with PCOS. Metformin, in combination with lifestyle modification and oral contraceptive, reduces central adiposity, reduces total testosterone and increases HDL, but does not enhance overall weight reduction.