Conditions: Polycystic Ovary Syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 65
Healthy volunteers: yes

Brief summary:
The purpose is to investigate the effects of 2 different treatments (drospirenone/ethinyl estradiol versus rosiglitazone) on insulin sensitivity and androgen levels, inflammatory markers, vascular markers and bone development in overweight adolescent females with polycystic ovary syndrome (PCOS).

Detailed description:
The purpose of this study is to:

1\) to compare effects of treatment with drospirenone/ethinyl estradiol (Yasmin)versus rosiglitazone (Avandia) on hyperandrogenism, insulin resistance/hyperinsulinemia, adrenal hyperresponsiveness, body composition, chronic inflammation, bone mass and turnover.

OCPs are the first-line therapy for PCOS, however, they do not address the insulin resistance or the inflammation. Insulin sensitizers have been used successfully to treat PCOS but thiazolidinediones such as rosiglitazone have not been used in adolescents. Therefore we will investigate the effects of treatment with drospirenone/ethinyl estradiol versus rosiglitazone in overweight adolescents with PCOS. We will obtain comprehensive evaluations before and 6 months after randomization, to the respective treatment arms to determine the differences between the 2 treatment modalities.

Arms:
arm 1: Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone arm 2: Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol arm 3: Overweight adolescent females without PCOS to use as comparison of normal developmental changes. \*No participants were enrolled in this Arm. arm 4: Lean healthy girls without PCOS to serve as controls for the cardiovascular markers. \*No participants were enrolled in this Arm.

Interventions: intervention 1: rosiglitazone intervention 2: drospirenone/ethinyl estradiol
Intervention descriptions: intervention 1: 4 mg daily for 6 months intervention 2: 1 tab (3mg/30mcg) daily for 6 months

Protocol document: