Official Title: “Obesity, Insulin Resistance, and Bone Metabolism in Adolescents With PCOS: Effects of Insulin Sensitizers Versus Oral Contraceptives”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: April 2009

The purpose of this study is to:

1) to compare effects of treatment with drospirenone/ethinyl estradiol versus rosiglitazone 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.

Intervention(s) in this Clinical Trial

• Drug: rosiglitazone
  • 4 mg daily for 6 months
• Drug: drospirenone/ethinyl estradiol
  • 1 tab (3mg/30mcg) daily for 6 months

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone
• Active Comparator: 2
  • Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol
• No Intervention: 3
  • Overweight adolescent females without PCOS to use as comparison of normal developmental changes.

Primary Measures

• To compare the effects of 6 months of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on hyperandrogenism, insulin resistance, inflammation and bone turnover.
  • Time Frame: 6 months
    Safety Issue?: Yes

Secondary Measures

• To compare the changes within the PCOS group to normal developmental changes in overweight females without PCOS
  • Time Frame: 6 months
    Safety Issue?: Yes

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)

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 10 Years

Maximum Age for this Clinical Trial: 20 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Children's Hospital of Pittsburgh

Overall Clinical Trial Officials and Contacts

Silva Arslanian, M.D. Principal Investigator University of Pittsburgh  

Overall Contact: Marcia DeLeo, CRNP 412-692-5239 marcia.deleo@chp.edu

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00640224

Study ID Number: 0503013

ClinicalTrials.gov Identifier: NCT00640224

Health Authority: United States: Food and Drug Administration