Clinical trial · Interventional
Combination Metformin and Oral Contraception for Polycystic Ovary Syndrome (PCOS)
NCT00682890CI-TRIAL-00015427terminatedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of recruitment
Summary
Brief summary (as posted)
The purpose of this research study is to determine if adding Metformin, a drug that reduces insulin resistance, to birth control pills will reduce the risk of developing type 2 diabetes, high blood pressure. high lipid levels and heart disease in women with PCOS
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Insulin Sensitivity | — | UNRESOLVED | — |
| PCOS | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| metformin | Drug | Metformin | ALIAS |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- 1
- description
- Placebo tablet and birth control pill daily
- interventionNames
- Drug: placebo
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- metformin 2000 mg and birth control pill daily
- interventionNames
- Drug: metformin
Primary outcomes (2)
- measure
- Change in Insulin Sensitivity Measures: Insulin Sensitivity Index (ISI)
- timeFrame
- baseline and 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Ages 18-45, , 8 menstrual cycles annually, elevated serum free testosterone, normal thyroid function test and serum prolactin, exclusion of late onset adrenal hyperplasia Exclusion Criteria: * Diabetes mellitus, pulmonary, cardiac, renal, hepatic, cholestatic, neurologic, psychiatric, infectious, malignant diseases,history of breast cancer, history of Deep Vein Thrombosis, pregnancy and lactation.
References
Publications (1)
- RESULTEssah PA, Arrowood JA, Cheang KI, Adawadkar SS, Stovall DW, Nestler JE. Effect of combined metformin and oral contraceptive therapy on metabolic factors and endothelial function in overweight and obese women with polycystic ovary syndrome. Fertil Steril. 2011 Aug;96(2):501-504.e2. doi: 10.1016/j.fertnstert.2011.05.091. Epub 2011 Jul 5. PMID 21733508