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

Completed · Phase 2 · Has a placebo group

Conditions studied: Infertility

In brief

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.

Key facts

Study ID

NCT00796289

Run by

Ferring Pharmaceuticals

People needed

350

Starts

2009-02-01

Expected to finish

2010-01-01

Last updated by the study team

2015-09-09

Who can join

Age: 18 and older, up to 38. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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
• Women's Health Practice — Champaign, Illinois, United States
• University of Kentucky — Lexington, Kentucky, United States
• A Woman's Center for Reproductive Medicine — Baton Rouge, Louisiana, United States
• Maine Medical Center — Portland, Maine, United States
• Shady Grove Fertility Center — Rockville, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Hutzel Women's Health Specialists — Detroit, Michigan, United States
• CAREM Canadian American Reproductive Medicine — Hamtramck, Michigan, United States
• Women's Clinic of Lincoln, P.C. — Lincoln, Nebraska, United States
• Fertility Center of Las Vegas — Las Vegas, Nevada, 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 — The Bronx, New York, United States
• Lyndhurst Gynecologic Associates — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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