drugset / Trial / NCT01909141

Ovulation Induction in Women With Clomiphene Citrate Resistant PCOS

NCT01909141

Phase 0 Completed 100 enrolled Cairo University
RandomizedParallel-groupDouble-blindTreatment

Summary

Polycystic ovary syndrome (PCOS) affects 5-10% of women in childbearing age. Hyperinsulinemia contributes to chronic anovulation commonly encountered in women with PCOS. The first choice therapy is clomiphene citrate (CC). In CC resistant cases, the American College of Obstetrics and Gynecology (ACOG) recommends the use of insulin sensitizer metformin. Other insulin sensitizing agents include rosiglitazone and pioglitazone. Pioglitazone is said to improve fertility and ovulation in patients with PCOS.CC may be associated with poor endometrial thickening due to its antiestrogenic effect. Letrozole may improve this condition. In this study we will compare the effect of combined letrozole-metformin-pioglitazone with that of combined CC-metformin-pioglitazone in ovulation induction in CC-resistant PCOS women.

Timeline

Start
2013-08
Primary completion
2014-02
Completion
2014-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clomiphene Other / unclassified 100 mg
Comparator Letrozole Other / unclassified 2.5 mg
Comparator Metformin Small molecule 850 mg
Comparator Pioglitazone Small molecule 15 mg