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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

Primary Purpose

Infertility

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GnRH iontophoretic transdermal Lutrepatch
GnRH iontophoretic transdermal Lutrepatch
GnRH iontophoretic transdermal Lutrepatch
clomiphene citrate
placebo clomiphene citrate
placebo GnRH patch
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring anovulatory/oligoovulatory infertility

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Watching Over Mothers and Babies Foundation
  • NEA Women's Clinic
  • San Diego Fertility Center
  • Compass Clinical Research
  • North Coast Women's Care Medical Group
  • Huntington Reproductive Center
  • Florida Fertility Institute
  • All Women's Healthcare of Wesy Broward, Inc.
  • Atlanta Center for Reproductive Medicine
  • Georgia Reproductive Specialists
  • Women's Health Practice
  • University of Kentucky
  • A Woman's Center for Reproductive Medicine
  • Maine Medical Center
  • Shady Grove Fertility Center
  • Massachusetts General Hospital
  • Hutzel Women's Health Specialists
  • CAREM Canadian American Reproductive Medicine
  • Women's Clinic of Lincoln, P.C.
  • Fertility Center of Las Vegas
  • The Medical Group of Northern Nevada
  • Women's Health Research Center LLC
  • Albert Einstein College of Medicine
  • Columbia University
  • Lyndhurst Gynecologic Associates
  • Institute for Reproductive Health
  • Greater Cincinnati OB/GYN, Inc./Reproductive Medicine Research
  • University Hospitals of Cleveland
  • Clinical Trials of America Inc
  • Center for Health and Healing
  • Greenville Hospital System
  • Research Memphis Associates, LLC
  • Center for Assisted Reproduction
  • The Methodist Hospital
  • Center of Reproductive Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

GnRH High Target Delivery

GnRH Medium Target Delivery

GnRH Low Target Delivery

Clomiphene Citrate

Placebo

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

Ovulation rate

Secondary Outcome Measures

Pregnancy rate
Incidence of Ovarian Hyperstimulation Syndrome (OHSS)
Incidence of skin irritation

Full Information

First Posted
November 20, 2008
Last Updated
August 26, 2015
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00796289
Brief Title
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

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
anovulatory/oligoovulatory infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GnRH High Target Delivery
Arm Type
Experimental
Arm Description
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
Arm Title
GnRH Medium Target Delivery
Arm Type
Experimental
Arm Description
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
Arm Title
GnRH Low Target Delivery
Arm Type
Experimental
Arm Description
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
Arm Title
Clomiphene Citrate
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
GnRH iontophoretic transdermal Lutrepatch
Other Intervention Name(s)
Lutrepatch, Gonadotropin-releasing hormone (GnRH)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
GnRH iontophoretic transdermal Lutrepatch
Other Intervention Name(s)
Gonadotropin-releasing hormone (GnRH), Lutrepatch
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
GnRH iontophoretic transdermal Lutrepatch
Other Intervention Name(s)
Gonadotropin-releasing hormone (GnRH), Lutrepatch
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
clomiphene citrate
Other Intervention Name(s)
various tradenames
Intervention Description
Oral, 50 mg daily for 5 days
Intervention Type
Drug
Intervention Name(s)
placebo clomiphene citrate
Intervention Description
oral, taken for 5 days
Intervention Type
Drug
Intervention Name(s)
placebo GnRH patch
Intervention Description
Placebo transdermal patch with a high target delivery of placebo(every 90 minutes). New patch to be applied every 12 hours.
Primary Outcome Measure Information:
Title
Ovulation rate
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Pregnancy rate
Time Frame
30 days
Title
Incidence of Ovarian Hyperstimulation Syndrome (OHSS)
Time Frame
30 days
Title
Incidence of skin irritation
Time Frame
30 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Watching Over Mothers and Babies Foundation
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
NEA Women's Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
San Diego Fertility Center
City
San Diego
State/Province
California
ZIP/Postal Code
92130
Country
United States
Facility Name
Compass Clinical Research
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States
Facility Name
North Coast Women's Care Medical Group
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Huntington Reproductive Center
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Florida Fertility Institute
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
All Women's Healthcare of Wesy Broward, Inc.
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Atlanta Center for Reproductive Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Georgia Reproductive Specialists
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Women's Health Practice
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0293
Country
United States
Facility Name
A Woman's Center for Reproductive Medicine
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70815
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Shady Grove Fertility Center
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Hutzel Women's Health Specialists
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
CAREM Canadian American Reproductive Medicine
City
Hamtramck
State/Province
Michigan
ZIP/Postal Code
48212
Country
United States
Facility Name
Women's Clinic of Lincoln, P.C.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Fertility Center of Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89117
Country
United States
Facility Name
The Medical Group of Northern Nevada
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Women's Health Research Center LLC
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Lyndhurst Gynecologic Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Institute for Reproductive Health
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45209
Country
United States
Facility Name
Greater Cincinnati OB/GYN, Inc./Reproductive Medicine Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0457
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Clinical Trials of America Inc
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Center for Health and Healing
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Greenville Hospital System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Research Memphis Associates, LLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Center for Assisted Reproduction
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Center of Reproductive Medicine
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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