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

Condition(s) targeted: Infertility

Intervention: GnRH iontophoretic transdermal Lutrepatch (Drug); GnRH iontophoretic transdermal Lutrepatch (Drug); GnRH iontophoretic transdermal Lutrepatch (Drug); clomiphene citrate (Drug); placebo clomiphene citrate (Drug); placebo GnRH patch (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Ferring Pharmaceuticals

Official(s) and/or principal investigator(s):
Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals

Overall contact:
Clinical Development Support, Email: DK0-Disclosure@ferring.com

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Ovulation rate

Secondary outcome:

Pregnancy rate

Incidence of Ovarian Hyperstimulation Syndrome (OHSS)

Incidence of skin irritation

Minimum age: 18 Years. Maximum age: 38 Years. Gender(s): Female.

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

Clinical Development Support, Email: DK0-Disclosure@ferring.com

Watching Over Mothers and Babies Foundation, Tucson, Arizona 85712, United States; Recruiting

NEA Women's Clinic, Jonesboro, Arkansas 72401, United States; Recruiting

North Coast Women's Care Medical Group, Vista, California 92083, United States; Recruiting

San Diego Fertility Center, San Diego, California 92130, United States; Recruiting

Huntington Reproductive Center, Westlake Village, California 91361, United States; Recruiting

Compass Clinical Research, San Ramon, California 94583, United States; Recruiting

Florida Fertility Institute, Clearwater, Florida 33759, United States; Recruiting

All Women's Healthcare of Wesy Broward, Inc., Plantation, Florida 33324, United States; Recruiting

Georgia Reproductive Specialists, Atlanta, Georgia 30342, United States; Recruiting

Atlanta Center for Reproductive Medicine, Atlanta, Georgia 30328, United States; Recruiting

Women's Health Practice, Champaign, Illinois 61820, United States; Recruiting

University of Kentucky, Lexington, Kentucky 40536-0293, United States; Recruiting

A Woman's Center for Reproductive Medicine, Baton Rouge, Louisiana 70815, United States; Recruiting

Maine Medical Center, Portland, Maine 04102, United States; Recruiting

Shady Grove Fertility Center, Rockville, Maryland 20850, United States; Recruiting

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting

Hutzel Women's Health Specialists, Detroit, Michigan 48201, United States; Recruiting

CAREM Canadian American Reproductive Medicine, Hamtramck, Michigan 48212, United States; Recruiting

Women's Clinic of Lincoln, P.C., Lincoln, Nebraska 68510, United States; Recruiting

The Medical Group of Northern Nevada, Reno, Nevada 89502, United States; Recruiting

Fertility Center of Las Vegas, Las Vegas, Nevada 89117, United States; Recruiting

Women's Health Research Center LLC, Lawrenceville, New Jersey 08648, United States; Recruiting

Albert Einstein College of Medicine, Bronx, New York 10461, United States; Recruiting

Columbia University, New York, New York 10032, United States; Recruiting

Lyndhurst Gynecologic Associates, Winston-Salem, North Carolina 27103, United States; Recruiting

University Hospitals of Cleveland, Cleveland, Ohio 44106, United States; Recruiting

Greater Cincinnati OB/GYN, Inc./Reproductive Medicine Research, Cincinnati, Ohio 45267-0457, United States; Recruiting

Institute for Reproductive Health, Cincinnati, Ohio 45209, United States; Recruiting

Center for Health and Healing, Portland, Oregon 97239, United States; Recruiting

Clinical Trials of America Inc, Eugene, Oregon 97401, United States; Recruiting

Greenville Hospital System, Greenville, South Carolina 29605, United States; Recruiting

Research Memphis Associates, LLC, Memphis, Tennessee 38119, United States; Recruiting

Center for Assisted Reproduction, Bedford, Texas 76022, United States; Recruiting

The Methodist Hospital, Houston, Texas 77030, United States; Recruiting

Center of Reproductive Medicine, Webster, Texas 77598, United States; Recruiting

Starting date: February 2009
Ending date: April 2010
Last updated: June 4, 2009