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
Conditions:Women's Studies, Infertility
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 38
Updated:10/14/2017
Start Date:February 2009
End Date:January 2010

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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

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.


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
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