Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study

Silva Arslanian

Status and phase: Completed; Phase 4

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: rosiglitazone; Drug: drospirenone/ethinyl estradiol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00640224

0503013

2K24HD001357 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 65 patients

Sex: Female

Ages: 10 to 20 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 10 - 20 years
• Pubertal level of Tanner stage III-V and menarchal
• BMI percentile for age and sex greater than or equal to 85%ile

Exclusion criteria

• Oral medications for PCOS, or that have impact on bone (i.e. anti-epileptics)
• Presence of other diseases, systemic or psychiatric, or chronic medications which could interfere with endocrine function
• Established diagnosis of diabetes
• Prior bone surgery, prior osteoporotic fracture, or fracture in the past 12 months
• Prior thromboembolic event, such as a deep venous thrombosis or pulmonary embolism (PCOS subjects only)
• Vitamin D deficiency (<10ng/mL)
• Hyperkalemia (K>5.0 meq/L)
• Positive pregnancy test (serum)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 4 patient groups

Rosiglitazone

Active Comparator group

Description:

Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone

Treatment:

Drug: rosiglitazone

Drospirenone/ethinyl estradiol

Active Comparator group

Description:

Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol

Treatment:

Drug: drospirenone/ethinyl estradiol

Overweight/Obese without PCOS

No Intervention group

Description:

Overweight adolescent females without PCOS to use as comparison of normal developmental changes. \*No participants were enrolled in this Arm.

Lean without PCOS

No Intervention group

Description:

Lean healthy girls without PCOS to serve as controls for the cardiovascular markers. \*No participants were enrolled in this Arm.