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

Phase 2

Completed

• Conditions: Infertility
• Interventions: Drug: clomiphene citrate; Drug: GnRH iontophoretic transdermal Lutrepatch; Drug: placebo clomiphene citrate; Drug: placebo GnRH patch

• Registration Number: NCT00796289
• Lead Sponsor: Ferring Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-20
• Study First Submitted QC: 2008-11-21
• Study First Posted: 2008-11-24
• Study Start: 2009-02
• Primary Completion: 2009-12
• Study Completion: 2010-01
• Disposition First Submitted: 2010-12-16
• Disposition First Submitted QC: 2010-12-16
• Disposition First Posted: 2010-12-22
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-26
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GnRH High Target Delivery	placebo clomiphene citrate	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
GnRH Medium Target Delivery	placebo clomiphene citrate	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
GnRH Low Target Delivery	placebo clomiphene citrate	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
Clomiphene Citrate	clomiphene citrate	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
Clomiphene Citrate	placebo GnRH patch	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
Placebo	placebo clomiphene citrate	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
Placebo	placebo GnRH patch	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
GnRH High Target Delivery	GnRH iontophoretic transdermal Lutrepatch	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
GnRH Medium Target Delivery	GnRH iontophoretic transdermal Lutrepatch	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
GnRH Low Target Delivery	GnRH iontophoretic transdermal Lutrepatch	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

Primary Outcome Measures

Name	Time	Method
Ovulation rate	30 days

Secondary Outcome Measures

Name	Time	Method
Pregnancy rate	30 days
Incidence of Ovarian Hyperstimulation Syndrome (OHSS)	30 days
Incidence of skin irritation	30 days

Trial Locations

Locations (35)

Watching Over Mothers and Babies Foundation; 🇺🇸 Tucson, Arizona, United States

NEA Women's Clinic; 🇺🇸 Jonesboro, Arkansas, United States

San Diego Fertility Center; 🇺🇸 San Diego, California, United States

Compass Clinical Research; 🇺🇸 San Ramon, California, United States

North Coast Women's Care Medical Group; 🇺🇸 Vista, California, United States

Huntington Reproductive Center; 🇺🇸 Westlake Village, California, United States

Florida Fertility Institute; 🇺🇸 Clearwater, Florida, United States

All Women's Healthcare of Wesy Broward, Inc.; 🇺🇸 Plantation, Florida, United States

Atlanta Center for Reproductive Medicine; 🇺🇸 Atlanta, Georgia, United States

Georgia Reproductive Specialists; 🇺🇸 Atlanta, Georgia, United States

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