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

A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH Delivered From a Iontophoretic Patch (Lutrepatch) Compared to Oral Treatment With Clomiphene Citrate or Placebo in Anovulatory or Oligoovulatory Infertile Females

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years – 38 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	GnRH iontophoretic transdermal Lutrepatch	10 mg GnRH iontopheretic transdermal patch. A new patch is applied two times each day (every 12 hours). Delivery current and membrane thickness adjusted to deliver the 'high target' study dose, which is estimated to be 800 picograms/ml
DRUG	GnRH iontophoretic transdermal Lutrepatch	10 mg GnRH iontopheretic transdermal patch. A new patch is applied two times each day(every 12 hours). Delivery current and membrane thickness adjusted to deliver the 'medium target' study dose, which is estimated to be 400-600 picograms/ml
DRUG	GnRH iontophoretic transdermal Lutrepatch	10 mg GnRH iontopheretic transdermal patch. A new patch is applied two times each day (every 12 hours). Delivery current and membrane thickness adjusted to deliver the 'low target' study dose, which is estimated to be 200 picograms/ml
DRUG	clomiphene citrate	Oral, 50 mg daily for 5 days
DRUG	placebo clomiphene citrate	oral, taken for 5 days
DRUG	placebo GnRH patch	Placebo transdermal patch with a high target delivery of placebo(every 90 minutes). New patch to be applied every 12 hours.

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-12-01
• Completion: 2010-01-01
• First posted: 2008-11-24
• Last updated: 2015-09-09

Locations

35 sites across 1 country: United States