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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Citric Acid; Clomiphene; Enclomiphene; Hormones; Prolactin Release-Inhibiting Factors; Sodium Citrate; Zuclomiphene

Criteria

Inclusion Criteria:

1. Females between the ages of 18 and 38 years

2. Desire to become pregnant

3. Infertile due to ovulatory dysfunction as described below:

• Unable to conceive for at least 1 year and

• Anovulatory (defined as 4 or fewer menstrual cycles per year) or Oligo-ovulatory (defined as menstrual cycle frequency > 45 days)

Exclusion Criteria:

1. Requires donor oocytes or sperm

2. Two or more failed (defined as no biochemical pregnancy achieved) gonadotropin fertility treatment cycles - if previous gonadotropin success, no more than two failed subsequent cycles

3. Use of insulin-sensitizing drugs (e.g., Metformin) within 1 month prior to progesterone challenge