drugset / Trial / NCT02341703

Ovulation Induction in Clomiphene Citrate Resistant PCO Women

NCT02341703

Phase 0 Completed 100 enrolled Cairo University
RandomizedParallel-groupOpen-labelTreatment

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 with that of combined letrozole-pioglitazone in ovulation induction in CC-resistant PCOS women

Timeline

Start
2015-02
Primary completion
2015-07
Completion
2015-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metformin Small molecule 500 mg
Comparator Metformin Small molecule 850 mg
Comparator Pioglitazone Small molecule 15 mg
Comparator Letrozole Other / unclassified 2.5 mg