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
- Conditions
- Infertility
- Interventions
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 350
-
Females between the ages of 18 and 38 years
-
Desire to become pregnant
-
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)
- Requires donor oocytes or sperm
- 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
- 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 Incidence of Ovarian Hyperstimulation Syndrome (OHSS) 30 days Incidence of skin irritation 30 days Pregnancy rate 30 days
Trial Locations
- Locations (35)
Florida Fertility Institute
🇺🇸Clearwater, Florida, United States
All Women's Healthcare of Wesy Broward, Inc.
🇺🇸Plantation, Florida, United States
A Woman's Center for Reproductive Medicine
🇺🇸Baton Rouge, Louisiana, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Georgia Reproductive Specialists
🇺🇸Atlanta, Georgia, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
San Diego Fertility Center
🇺🇸San Diego, California, United States
Hutzel Women's Health Specialists
🇺🇸Detroit, Michigan, United States
Fertility Center of Las Vegas
🇺🇸Las Vegas, Nevada, United States
Institute for Reproductive Health
🇺🇸Cincinnati, Ohio, United States
Greater Cincinnati OB/GYN, Inc./Reproductive Medicine Research
🇺🇸Cincinnati, Ohio, United States
Center for Health and Healing
🇺🇸Portland, Oregon, United States
Women's Clinic of Lincoln, P.C.
🇺🇸Lincoln, Nebraska, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
NEA Women's Clinic
🇺🇸Jonesboro, Arkansas, United States
Center for Assisted Reproduction
🇺🇸Bedford, Texas, United States
Research Memphis Associates, LLC
🇺🇸Memphis, Tennessee, United States
Watching Over Mothers and Babies Foundation
🇺🇸Tucson, Arizona, United States
Compass Clinical Research
🇺🇸San Ramon, California, United States
North Coast Women's Care Medical Group
🇺🇸Vista, California, United States
Atlanta Center for Reproductive Medicine
🇺🇸Atlanta, Georgia, United States
Huntington Reproductive Center
🇺🇸Westlake Village, California, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Women's Health Practice
🇺🇸Champaign, Illinois, United States
Shady Grove Fertility Center
🇺🇸Rockville, Maryland, United States
CAREM Canadian American Reproductive Medicine
🇺🇸Hamtramck, Michigan, United States
The Medical Group of Northern Nevada
🇺🇸Reno, Nevada, United States
Women's Health Research Center LLC
🇺🇸Lawrenceville, New Jersey, United States
Columbia University
🇺🇸New York, New York, United States
Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
Lyndhurst Gynecologic Associates
🇺🇸Winston-Salem, North Carolina, United States
Clinical Trials of America Inc
🇺🇸Eugene, Oregon, United States
Greenville Hospital System
🇺🇸Greenville, South Carolina, United States
Center of Reproductive Medicine
🇺🇸Webster, Texas, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States