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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00796289
• Other study ID #: 2008-03
• Status: Completed
• Phase: Phase 2
• First received: November 20, 2008
• Last updated: August 26, 2015
• Start date: February 2009
• Est. completion date: January 2010

Study information

• Verified date: August 2015
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• GnRH iontophoretic transdermal Lutrepatch
10 mg GnRH iontopheretic transdermal patch. A new patch is applied two times each day (every 12 hours). Delivery current and membrane thickness adjusted to deliver the 'high target' study dose, which is estimated to be 800 picograms/ml
• GnRH iontophoretic transdermal Lutrepatch
10 mg GnRH iontopheretic transdermal patch. A new patch is applied two times each day(every 12 hours). Delivery current and membrane thickness adjusted to deliver the 'medium target' study dose, which is estimated to be 400-600 picograms/ml
• GnRH iontophoretic transdermal Lutrepatch
10 mg GnRH iontopheretic transdermal patch. A new patch is applied two times each day (every 12 hours). Delivery current and membrane thickness adjusted to deliver the 'low target' study dose, which is estimated to be 200 picograms/ml
• clomiphene citrate
Oral, 50 mg daily for 5 days
• placebo clomiphene citrate
oral, taken for 5 days
• placebo GnRH patch
Placebo transdermal patch with a high target delivery of placebo(every 90 minutes). New patch to be applied every 12 hours.

Locations

Country	Name	City	State
United States	Atlanta Center for Reproductive Medicine	Atlanta	Georgia
United States	Georgia Reproductive Specialists	Atlanta	Georgia
United States	A Woman's Center for Reproductive Medicine	Baton Rouge	Louisiana
United States	Center for Assisted Reproduction	Bedford	Texas
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Albert Einstein College of Medicine	Bronx	New York
United States	Women's Health Practice	Champaign	Illinois
United States	Greater Cincinnati OB/GYN, Inc./Reproductive Medicine Research	Cincinnati	Ohio
United States	Institute for Reproductive Health	Cincinnati	Ohio
United States	Florida Fertility Institute	Clearwater	Florida
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Hutzel Women's Health Specialists	Detroit	Michigan
United States	Clinical Trials of America Inc	Eugene	Oregon
United States	Greenville Hospital System	Greenville	South Carolina
United States	CAREM Canadian American Reproductive Medicine	Hamtramck	Michigan
United States	The Methodist Hospital	Houston	Texas
United States	NEA Women's Clinic	Jonesboro	Arkansas
United States	Fertility Center of Las Vegas	Las Vegas	Nevada
United States	Women's Health Research Center LLC	Lawrenceville	New Jersey
United States	University of Kentucky	Lexington	Kentucky
United States	Women's Clinic of Lincoln, P.C.	Lincoln	Nebraska
United States	Research Memphis Associates, LLC	Memphis	Tennessee
United States	Columbia University	New York	New York
United States	All Women's Healthcare of Wesy Broward, Inc.	Plantation	Florida
United States	Center for Health and Healing	Portland	Oregon
United States	Maine Medical Center	Portland	Maine
United States	The Medical Group of Northern Nevada	Reno	Nevada
United States	Shady Grove Fertility Center	Rockville	Maryland
United States	San Diego Fertility Center	San Diego	California
United States	Compass Clinical Research	San Ramon	California
United States	Watching Over Mothers and Babies Foundation	Tucson	Arizona
United States	North Coast Women's Care Medical Group	Vista	California
United States	Center of Reproductive Medicine	Webster	Texas
United States	Huntington Reproductive Center	Westlake Village	California
United States	Lyndhurst Gynecologic Associates	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovulation rate		30 days
Secondary	Pregnancy rate		30 days
Secondary	Incidence of Ovarian Hyperstimulation Syndrome (OHSS)		30 days
Secondary	Incidence of skin irritation		30 days