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

Ferring

Status and phase: Completed; Phase 2

Conditions: Infertility

Treatments: Drug: GnRH iontophoretic transdermal Lutrepatch; Drug: placebo clomiphene citrate; Drug: clomiphene citrate; Drug: placebo GnRH patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT00796289

2008-03

Details and patient eligibility

About

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.

Enrollment: 350 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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350 participants in 5 patient groups, including a placebo group

GnRH High Target Delivery

Experimental group

Description:

10 mg GnRH iontophoretic transdermal Lutrepatch with a high target delivery of pulsatile GnRH (every 90 minutes) for 21 days and oral placebo clomiphene citrate for 5 days

Treatment:

Drug: placebo clomiphene citrate

Drug: GnRH iontophoretic transdermal Lutrepatch

Drug: GnRH iontophoretic transdermal Lutrepatch

Drug: GnRH iontophoretic transdermal Lutrepatch

GnRH Medium Target Delivery

Experimental group

Description:

10 mg GnRH iontophoretic transdermal Lutrepatch with a medium target delivery of pulsatile GnRH (every 90 minutes) for 21 days and oral placebo clomiphene citrate for 5 days

Treatment:

Drug: placebo clomiphene citrate

Drug: GnRH iontophoretic transdermal Lutrepatch

Drug: GnRH iontophoretic transdermal Lutrepatch

Drug: GnRH iontophoretic transdermal Lutrepatch

GnRH Low Target Delivery

Experimental group

Description:

10 mg GnRH iontophoretic transdermal Lutrepatch with a low target delivery of pulsatile GnRH (every 90 minutes) for 21 days and oral placebo clomiphene citrate for 5 days

Treatment:

Drug: placebo clomiphene citrate

Drug: GnRH iontophoretic transdermal Lutrepatch

Drug: GnRH iontophoretic transdermal Lutrepatch

Drug: GnRH iontophoretic transdermal Lutrepatch

Clomiphene Citrate

Active Comparator group

Description:

Placebo GnRH iontophoretic transdermal Lutrepatch with a high target delivery of pulsatile current (every 90 minutes) for 21 days and oral 50 mg clomiphene citrate for 5 days

Treatment:

Drug: placebo GnRH patch

Drug: clomiphene citrate

Placebo

Placebo Comparator group

Description:

Placebo GnRH iontophoretic transdermal Lutrepatch with a high target delivery of pulsatile current (every 90 minutes) for 21 days and oral placebo clomiphene citrate for 5 days

Treatment:

Drug: placebo clomiphene citrate

Drug: placebo GnRH patch