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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Infertility

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GnRH High Target Delivery<br>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<br>* 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<br>* Other names: Gonadotropin-releasing hormone (GnRH);Drug: placebo clomiphene citrate<br>* oral, taken for 5 days<br>|
| Experimental: GnRH Medium Target Delivery<br>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<br>* 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<br>* Other names: Lutrepatch;Drug: placebo clomiphene citrate<br>* oral, taken for 5 days<br>|
| Experimental: GnRH Low Target Delivery<br>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<br>* 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<br>* Other names: Lutrepatch;Drug: placebo clomiphene citrate<br>* oral, taken for 5 days<br>|
| Active Comparator: Clomiphene Citrate<br>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<br>* Oral, 50 mg daily for 5 days<br>* Other names: various tradenames;Drug: placebo GnRH patch<br>* Placebo transdermal patch with a high target delivery of placebo(every 90 minutes). New patch to be applied every 12 hours.<br>|
| Placebo Comparator: Placebo<br>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<br>* oral, taken for 5 days<br>Drug: placebo GnRH patch<br>* Placebo transdermal patch with a high target delivery of placebo(every 90 minutes). New patch to be applied every 12 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovulation rate |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate |  | 30 days | 
| Incidence of Ovarian Hyperstimulation Syndrome (OHSS) |  | 30 days | 
| Incidence of skin irritation |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anovulatory/oligoovulatory infertility