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Sponsored by: |
Ferring Pharmaceuticals |
---|---|
Information provided by: | Ferring Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00796289 |
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 |
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 |
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 |
Ages Eligible for Study: | 18 Years to 38 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Infertile due to ovulatory dysfunction as described below:
Exclusion Criteria:
Contact: Keisha Moragne, B.A | 973-796-1600 | keisha.moragne@ferring.com |
United States, Florida | |
Florida Fertility Institute | Recruiting |
Clearwater, Florida, United States, 33759 | |
Contact: Edward Zbella, M.D |
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 |
anovulatory/oligoovulatory infertility |
Genital Diseases, Female Infertility Citric Acid Clomiphene Genital Diseases, Male |
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 |