drugset / Trial / NCT02802865

Combined Letrozole and Clomid in Women With Infertility and PCOS

NCT02802865 ↗

Phase 4 Completed 70 enrolled Rachel Mejia
RandomizedParallel-groupOpen-labelTreatment

Summary

This study evaluates the addition of clomid to letrozole for the treatment of infertility in women with polycystic ovary syndrome. Half of the participants will receive letrozole and clomid in combination, while the other half will receive letrozole alone.

Timeline

Start
2016-08
Primary completion
2018-05
Completion
2019-02

Outcome

Met primary endpoint

registry analysis (superiority test); Letrozole vs Letrozole + Clomiphene; p = 0.007; Rate ratio 1.80 (95% CI 1.18 to 2.75); Chi-squared, Corrected NCT02802865 ↗

paper Women who received the combination of letrozole and CC had a statistically higher ovulation rate compared with those who received letrozole alone (27 of 35 women [77%] vs. 15 of 35 women [43%]). PMID 30683591 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Clomiphene Citrate Other / unclassified 50 mg Oral
Subject Letrozole Other / unclassified 2.5 mg Oral