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
NCT ID: NCT00796289
Last Updated: 2015-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
350 participants
INTERVENTIONAL
2009-02-28
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GnRH High Target Delivery
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 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
placebo clomiphene citrate
oral, taken for 5 days
GnRH Medium Target Delivery
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 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
placebo clomiphene citrate
oral, taken for 5 days
GnRH Low Target Delivery
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
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
placebo clomiphene citrate
oral, taken for 5 days
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
Oral, 50 mg daily 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.
Placebo
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 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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
38 Years
FEMALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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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
Institute for Reproductive Health
Cincinnati, Ohio, United States
Greater Cincinnati OB/GYN, Inc./Reproductive Medicine Research
Cincinnati, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Clinical Trials of America Inc
Eugene, Oregon, United States
Center for Health and Healing
Portland, Oregon, United States
Greenville Hospital System
Greenville, South Carolina, United States
Research Memphis Associates, LLC
Memphis, Tennessee, United States
Center for Assisted Reproduction
Bedford, Texas, United States
The Methodist Hospital
Houston, Texas, United States
Center of Reproductive Medicine
Webster, Texas, United States
Countries
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Other Identifiers
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2008-03
Identifier Type: -
Identifier Source: org_study_id
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