Overview

This trial is active, not recruiting.

Condition polycystic ovary syndrome
Treatments rosiglitazone, drospirenone/ethinyl estradiol
Phase phase 4
Sponsor Children's Hospital of Pittsburgh
Collaborator Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date March 2005
End date December 2015
Trial size 75 participants
Trial identifier NCT00640224, 0503013, 2K24HD001357

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone
rosiglitazone Avandia
4 mg daily for 6 months
(Active Comparator)
Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol
drospirenone/ethinyl estradiol Yasmin
1 tab (3mg/30mcg) daily for 6 months
(No Intervention)
Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
(No Intervention)
Lean healthy girls without PCOS to serve as controls for the cardiovascular markers

Primary Outcomes

Measure
To compare the effects of 6 months of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on insulin resistance.
time frame: 6 months

Secondary Outcomes

Measure
To compare the effects of 6 months of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on bone turnover
time frame: 6 months
To compare the effects of 6 months of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on hyperandrogenism
time frame: 6 months
To compare the effects of 6 months of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on cardiovascular health and inflammation
time frame: 6 months
To compare the markers of cardiovascular health and inflammation within the PCOS group to those in overweight females without PCOS and lean females without PCOS
time frame: Baseline

Eligibility Criteria

Female participants from 10 years up to 20 years old.

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)

Additional Information

Official title Obesity, Insulin Resistance, and Bone Metabolism in Adolescents With PCOS: Effects of Insulin Sensitizers Versus Oral Contraceptives
Principal investigator Silva Arslanian, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Children's Hospital of Pittsburgh.