Clinical trial NCT00796289: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infertility
Keywords: anovulatory/oligoovulatory infertility
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-11-24
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Females between the ages of 18 and 38 years
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:

1. Requires donor oocytes or sperm
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

Primary outcomes:
measure: Ovulation rate
timeFrame: 30 days
Secondary outcomes:
measure: Pregnancy rate
timeFrame: 30 days
measure: Incidence of Ovarian Hyperstimulation Syndrome (OHSS)
timeFrame: 30 days
measure: Incidence of skin irritation
timeFrame: 30 days
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Watching Over Mothers and Babies Foundation
state: Arizona
city: Jonesboro
country: United States
facility: NEA Women's Clinic
state: Arkansas
city: San Diego
country: United States
facility: San Diego Fertility Center
state: California
city: San Ramon
country: United States
facility: Compass Clinical Research
state: California
city: Vista
country: United States
facility: North Coast Women's Care Medical Group
state: California
city: Westlake Village
country: United States
facility: Huntington Reproductive Center
state: California
city: Clearwater
country: United States
facility: Florida Fertility Institute
state: Florida
city: Plantation
country: United States
facility: All Women's Healthcare of Wesy Broward, Inc.
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Reproductive Medicine
state: Georgia
city: Atlanta
country: United States
facility: Georgia Reproductive Specialists
state: Georgia
city: Champaign
country: United States
facility: Women's Health Practice
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Baton Rouge
country: United States
facility: A Woman's Center for Reproductive Medicine
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Rockville
country: United States
facility: Shady Grove Fertility Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Hutzel Women's Health Specialists
state: Michigan
city: Hamtramck
country: United States
facility: CAREM Canadian American Reproductive Medicine
state: Michigan
city: Lincoln
country: United States
facility: Women's Clinic of Lincoln, P.C.
state: Nebraska
city: Las Vegas
country: United States
facility: Fertility Center of Las Vegas
state: Nevada
city: Reno
country: United States
facility: The Medical Group of Northern Nevada
state: Nevada
city: Lawrenceville
country: United States
facility: Women's Health Research Center LLC
state: New Jersey
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Winston-Salem
country: United States
facility: Lyndhurst Gynecologic Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Institute for Reproductive Health
state: Ohio
city: Cincinnati
country: United States
facility: Greater Cincinnati OB/GYN, Inc./Reproductive Medicine Research
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Eugene
country: United States
facility: Clinical Trials of America Inc
state: Oregon
city: Portland
country: United States
facility: Center for Health and Healing
state: Oregon
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Memphis
country: United States
facility: Research Memphis Associates, LLC
state: Tennessee
city: Bedford
country: United States
facility: Center for Assisted Reproduction
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Webster
country: United States
facility: Center of Reproductive Medicine
state: Texas
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: