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 - Full Text View

Sponsored by:	Ferring Pharmaceuticals
Information provided by:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00796289

Purpose

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	Intervention	Phase
Infertility	Drug: GnRH iontophoretic transdermal Lutrepatch Drug: oral 50 mg clomiphene citrate Drug: oral placebo clomiphene citrate	Phase II

MedlinePlus related topics: Infertility

Drug Information available for: Citric acid Sodium Citrate Clomiphene citrate Clomiphene Enclomiphene Zuclomiphene Gonadorelin Gonadorelin hydrochloride LH-RH

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind
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

Further study details as provided by Ferring Pharmaceuticals:

Estimated Enrollment:	500
Study Start Date:	November 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Placebo Comparator 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
Group 2: Placebo Comparator 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
Group 3: Placebo Comparator 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
Group 4: Active Comparator 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: oral 50 mg clomiphene citrate
Group 5: Active Comparator 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: oral placebo clomiphene citrate

Eligibility

Ages Eligible for Study:	18 Years to 38 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796289

Contacts

Contact: Keisha Moragne, B.A

973-796-1600

keisha.moragne@ferring.com

Locations

United States, Florida
Florida Fertility Institute	Recruiting
Clearwater, Florida, United States, 33759
Contact: Edward Zbella, M.D

Sponsors and Collaborators

Ferring Pharmaceuticals

More Information

Responsible Party:	Ferring Pharmaceuticals ( Emily Blake MD )
Study ID Numbers:	2008-03
Study First Received:	November 20, 2008
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00796289
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ferring Pharmaceuticals:

anovulatory/oligoovulatory infertility

Study placed in the following topic categories:

Genital Diseases, Female
Infertility
Citric Acid
Clomiphene
Genital Diseases, Male

Additional relevant MeSH terms:

Estrogen Receptor Modulators
Estrogen Antagonists
Therapeutic Uses
Fertility Agents, Female
Hormone Antagonists
Fertility Agents

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009