Overview

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