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
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
1 other identifier
interventional
350
1 country
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2009
Shorter than P25 for phase_2
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2008
CompletedFirst Posted
Study publicly available on registry
November 24, 2008
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedSeptember 9, 2015
August 1, 2015
10 months
November 20, 2008
August 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ovulation rate
30 days
Secondary Outcomes (3)
Pregnancy rate
30 days
Incidence of Ovarian Hyperstimulation Syndrome (OHSS)
30 days
Incidence of skin irritation
30 days
Study Arms (5)
GnRH High Target Delivery
EXPERIMENTAL10 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
EXPERIMENTAL10 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
EXPERIMENTAL10 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
ACTIVE COMPARATORPlacebo 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 COMPARATORPlacebo 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
Interventions
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
Oral, 50 mg daily for 5 days
oral, taken for 5 days
Placebo transdermal patch with a high target delivery of placebo(every 90 minutes). New patch to be applied every 12 hours.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Watching Over Mothers and Babies Foundation
Tucson, Arizona, 85712, United States
NEA Women's Clinic
Jonesboro, Arkansas, 72401, United States
San Diego Fertility Center
San Diego, California, 92130, United States
Compass Clinical Research
San Ramon, California, 94583, United States
North Coast Women's Care Medical Group
Vista, California, 92083, United States
Huntington Reproductive Center
Westlake Village, California, 91361, United States
Florida Fertility Institute
Clearwater, Florida, 33759, United States
All Women's Healthcare of Wesy Broward, Inc.
Plantation, Florida, 33324, United States
Atlanta Center for Reproductive Medicine
Atlanta, Georgia, 30328, United States
Georgia Reproductive Specialists
Atlanta, Georgia, 30342, United States
Women's Health Practice
Champaign, Illinois, 61820, United States
University of Kentucky
Lexington, Kentucky, 40536-0293, United States
A Woman's Center for Reproductive Medicine
Baton Rouge, Louisiana, 70815, United States
Maine Medical Center
Portland, Maine, 04102, United States
Shady Grove Fertility Center
Rockville, Maryland, 20850, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Hutzel Women's Health Specialists
Detroit, Michigan, 48201, United States
CAREM Canadian American Reproductive Medicine
Hamtramck, Michigan, 48212, United States
Women's Clinic of Lincoln, P.C.
Lincoln, Nebraska, 68510, United States
Fertility Center of Las Vegas
Las Vegas, Nevada, 89117, United States
The Medical Group of Northern Nevada
Reno, Nevada, 89502, United States
Women's Health Research Center LLC
Lawrenceville, New Jersey, 08648, United States
Columbia University
New York, New York, 10032, United States
Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, 27103, United States
Institute for Reproductive Health
Cincinnati, Ohio, 45209, United States
Greater Cincinnati OB/GYN, Inc./Reproductive Medicine Research
Cincinnati, Ohio, 45267-0457, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Clinical Trials of America Inc
Eugene, Oregon, 97401, United States
Center for Health and Healing
Portland, Oregon, 97239, United States
Greenville Hospital System
Greenville, South Carolina, 29605, United States
Research Memphis Associates, LLC
Memphis, Tennessee, 38119, United States
Center for Assisted Reproduction
Bedford, Texas, 76022, United States
The Methodist Hospital
Houston, Texas, 77030, United States
Center of Reproductive Medicine
Webster, Texas, 77598, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2008
First Posted
November 24, 2008
Study Start
February 1, 2009
Primary Completion
December 1, 2009
Study Completion
January 1, 2010
Last Updated
September 9, 2015
Record last verified: 2015-08