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

Sponsor

Ferring Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00796289

Collaborator

(none)

350

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: GnRH iontophoretic transdermal Lutrepatch Drug: GnRH iontophoretic transdermal Lutrepatch Drug: GnRH iontophoretic transdermal Lutrepatch Drug: clomiphene citrate Drug: placebo clomiphene citrate Drug: placebo GnRH patch	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

350 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: 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 Other Names: Lutrepatch Gonadotropin-releasing hormone (GnRH) Drug: placebo clomiphene citrate oral, taken for 5 days
Experimental: 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	Drug: 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 Other Names: Gonadotropin-releasing hormone (GnRH) Lutrepatch Drug: placebo clomiphene citrate oral, taken for 5 days
Experimental: 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	Drug: 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 Other Names: Gonadotropin-releasing hormone (GnRH) Lutrepatch Drug: placebo clomiphene citrate oral, taken for 5 days
Active Comparator: 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	Drug: clomiphene citrate Oral, 50 mg daily for 5 days Other Names: various tradenames Drug: 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 Comparator: 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	Drug: placebo clomiphene citrate oral, taken for 5 days Drug: placebo GnRH patch Placebo transdermal patch with a high target delivery of placebo(every 90 minutes). New patch to be applied every 12 hours.

Outcome Measures

Primary Outcome Measures

Ovulation rate [30 days]

Secondary Outcome Measures

Pregnancy rate [30 days]
Incidence of Ovarian Hyperstimulation Syndrome (OHSS) [30 days]
Incidence of skin irritation [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 38 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Watching Over Mothers and Babies Foundation	Tucson	Arizona	United States	85712
2	NEA Women's Clinic	Jonesboro	Arkansas	United States	72401
3	San Diego Fertility Center	San Diego	California	United States	92130
4	Compass Clinical Research	San Ramon	California	United States	94583
5	North Coast Women's Care Medical Group	Vista	California	United States	92083
6	Huntington Reproductive Center	Westlake Village	California	United States	91361
7	Florida Fertility Institute	Clearwater	Florida	United States	33759
8	All Women's Healthcare of Wesy Broward, Inc.	Plantation	Florida	United States	33324
9	Atlanta Center for Reproductive Medicine	Atlanta	Georgia	United States	30328
10	Georgia Reproductive Specialists	Atlanta	Georgia	United States	30342
11	Women's Health Practice	Champaign	Illinois	United States	61820
12	University of Kentucky	Lexington	Kentucky	United States	40536-0293
13	A Woman's Center for Reproductive Medicine	Baton Rouge	Louisiana	United States	70815
14	Maine Medical Center	Portland	Maine	United States	04102
15	Shady Grove Fertility Center	Rockville	Maryland	United States	20850
16	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
17	Hutzel Women's Health Specialists	Detroit	Michigan	United States	48201
18	CAREM Canadian American Reproductive Medicine	Hamtramck	Michigan	United States	48212
19	Women's Clinic of Lincoln, P.C.	Lincoln	Nebraska	United States	68510
20	Fertility Center of Las Vegas	Las Vegas	Nevada	United States	89117
21	The Medical Group of Northern Nevada	Reno	Nevada	United States	89502
22	Women's Health Research Center LLC	Lawrenceville	New Jersey	United States	08648
23	Albert Einstein College of Medicine	Bronx	New York	United States	10461
24	Columbia University	New York	New York	United States	10032
25	Lyndhurst Gynecologic Associates	Winston-Salem	North Carolina	United States	27103
26	Institute for Reproductive Health	Cincinnati	Ohio	United States	45209
27	Greater Cincinnati OB/GYN, Inc./Reproductive Medicine Research	Cincinnati	Ohio	United States	45267-0457
28	University Hospitals of Cleveland	Cleveland	Ohio	United States	44106
29	Clinical Trials of America Inc	Eugene	Oregon	United States	97401
30	Center for Health and Healing	Portland	Oregon	United States	97239
31	Greenville Hospital System	Greenville	South Carolina	United States	29605
32	Research Memphis Associates, LLC	Memphis	Tennessee	United States	38119
33	Center for Assisted Reproduction	Bedford	Texas	United States	76022
34	The Methodist Hospital	Houston	Texas	United States	77030
35	Center of Reproductive Medicine	Webster	Texas	United States	77598