drugset / Trial / NCT00501839

Clomiphene Citrate in Infertile PCOS Patients

NCT00501839

Phase 4 Withdrawn University Magna Graecia
RandomizedParallel-groupOpen-labelTreatment

Summary

Anovulatory infertility is a common feature of the polycystic ovary syndrome (PCOS). Clomiphene citrate (CC) represents the first therapeutic option for treating the anovulatory infertility in PCOS patients because it is characterized by low costs, limited dose-dependent side effects, and simplicity of administration and management due to no need for ongoing monitoring. Excellent results in terms of ovulations have been obtained using CC. However, only 50% of patients who ovulates under CC will conceive. The exact explanation for the discrepancy between the ovulation and pregnancy rates is unknown, but several hypotheses on the anti-estrogenic effects that CC exerts on the ovary and uterus have been suggested. To date, few data are available on the optimal schedule for CC administration, and it is unknown how long patients who ovulate under CC should continue treatment before switching to second-line ovulation induction therapy. The aim of the study was to define the clinical benefits of CC administration according to its duration of administration.

Timeline

Start
2008-08
Primary completion
2010-09
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clomiphene Other / unclassified 150 mg