350
Participants
Start Date
February 28, 2009
Primary Completion Date
December 31, 2009
Study Completion Date
January 31, 2010
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.
Columbia University, New York
Albert Einstein College of Medicine, The Bronx
Shady Grove Fertility Center, Rockville
Lyndhurst Gynecologic Associates, Winston-Salem
Greenville Hospital System, Greenville
Atlanta Center for Reproductive Medicine, Atlanta
Georgia Reproductive Specialists, Atlanta
All Women's Healthcare of Wesy Broward, Inc., Plantation
Florida Fertility Institute, Clearwater
Research Memphis Associates, LLC, Memphis
University Hospitals of Cleveland, Cleveland
Institute for Reproductive Health, Cincinnati
Hutzel Women's Health Specialists, Detroit
CAREM Canadian American Reproductive Medicine, Hamtramck
Women's Health Practice, Champaign
Women's Clinic of Lincoln, P.C., Lincoln
A Woman's Center for Reproductive Medicine, Baton Rouge
NEA Women's Clinic, Jonesboro
Center for Assisted Reproduction, Bedford
The Methodist Hospital, Houston
Center of Reproductive Medicine, Webster
Watching Over Mothers and Babies Foundation, Tucson
Fertility Center of Las Vegas, Las Vegas
The Medical Group of Northern Nevada, Reno
Huntington Reproductive Center, Westlake Village
North Coast Women's Care Medical Group, Vista
San Diego Fertility Center, San Diego
Compass Clinical Research, San Ramon
Center for Health and Healing, Portland
Clinical Trials of America Inc, Eugene
University of Kentucky, Lexington
Maine Medical Center, Portland
Massachusetts General Hospital, Boston
Women's Health Research Center LLC, Lawrenceville
Greater Cincinnati OB/GYN, Inc./Reproductive Medicine Research, Cincinnati
Lead Sponsor
Ferring Pharmaceuticals
INDUSTRY