Clinical trial · Interventional
Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study
Obesity, Insulin Resistance, and Bone Metabolism in Adolescents With PCOS: Effects of Insulin Sensitizers Versus Oral Contraceptives
NCT00640224CI-TRIAL-00030421completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| drospirenone/ethinyl estradiol | Drug | — | UNRESOLVED |
| rosiglitazone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Rosiglitazone
- description
- Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone
- interventionNames
- Drug: rosiglitazone
- type
- ACTIVE_COMPARATOR
- label
- Drospirenone/ethinyl estradiol
- description
- Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol
- interventionNames
- Drug: drospirenone/ethinyl estradiol
- type
- NO_INTERVENTION
- label
- Overweight/Obese without PCOS
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 10 Years
- Maximum age
- 20 Years
Show eligibility criteria text
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)
References
Publications (1)
- RESULTTfayli H, Ulnach JW, Lee S, Sutton-Tyrrell K, Arslanian S. Drospirenone/ethinyl estradiol versus rosiglitazone treatment in overweight adolescents with polycystic ovary syndrome: comparison of metabolic, hormonal, and cardiovascular risk factors. J Clin Endocrinol Metab. 2011 May;96(5):1311-9. doi: 10.1210/jc.2010-2547. Epub 2011 Feb 16. PMID 21325466