Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Children's Hospital of Pittsburgh; Silva Arslanian
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Drospirenone; Drospirenone and ethinyl estradiol combination; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Insulin; Polyestradiol phosphate; Rosiglitazone

Criteria

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)