drugset / Trial / NCT00796289

Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH Delivered From a Iontophoretic Patch Compared to Oral Treatment With Clomiphene or Placebo in Infertile Females

NCT00796289

Phase 2 Completed 350 enrolled Ferring Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of this study is to determine the safety and efficacy of pulsatile GnRH delivered from a iontophoretic patch (Lutrepatch) for induction of ovulation in women with anovulatory/ oligoovulatory infertility, compared to placebo and to a reference treatment with clomiphene citrate.

Timeline

Start
2009-02
Primary completion
2009-12
Completion
2010-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clomiphene Other / unclassified 50 mg Oral
Subject Gonadotropin-releasing hormone (GnRH) Unknown 10 mg Other

Indications