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| Sponsor: | Ferring Pharmaceuticals |
|---|---|
| Information provided by: | Ferring Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00296465 |
Purpose
This study will be performed in approximately 132 women with anovulatory/oligoovulatory infertility.
| Condition | Intervention | Phase |
|---|---|---|
|
InFertility |
Drug: Pulsatile gonadotropin-releasing hormone (GnRH) Drug: Clomiphene Citrate Drug: Placebo Pulsatile GnRH Drug: Placebo Clomiphene Citrate |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH Administered Intravenously or Subcutaneously (Via Portable Infusion Pump) Compared to Oral Treatment With Clomiphene Citrate in Anovulatory or Oligoovulatory Infertile Females |
| Enrollment: | 132 |
| Study Start Date: | February 2005 |
| Study Completion Date: | November 2005 |
| Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lutrepulse® 5mcg IV
5.0 mcg Pulsatile GnRH (Lutrepulse®) administered intravenously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks and oral placebo clomiphene citrate for 5 days
|
Drug: Pulsatile gonadotropin-releasing hormone (GnRH)
Dosages as specified, administered either subcutaneously (SC) or intraveneously (IV) as specified, via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
Other Name: Lutrepulse®
Drug: Placebo Clomiphene Citrate
oral placebo clomiphene citrate for 5 days
|
|
Experimental: Lutrepulse® 10 mcg IV
10.0 mcg Pulsatile GnRH (Lutrepulse®) administered intravenously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks and oral placebo clomiphene citrate for 5 days
|
Drug: Pulsatile gonadotropin-releasing hormone (GnRH)
Dosages as specified, administered either subcutaneously (SC) or intraveneously (IV) as specified, via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
Other Name: Lutrepulse®
Drug: Placebo Clomiphene Citrate
oral placebo clomiphene citrate for 5 days
|
|
Experimental: Lutrepulse® 20 mcg SC
20.0 mcg Pulsatile GnRH (Lutrepulse®) administered subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks and oral placebo clomiphene citrate for 5 days
|
Drug: Pulsatile gonadotropin-releasing hormone (GnRH)
Dosages as specified, administered either subcutaneously (SC) or intraveneously (IV) as specified, via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
Other Name: Lutrepulse®
Drug: Placebo Clomiphene Citrate
oral placebo clomiphene citrate for 5 days
|
|
Placebo Comparator: Placebo IV
Placebo Pulsatile GnRH (Lutrepulse®) administered intravenously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks and oral placebo clomiphene citrate for 5 days
|
Drug: Placebo Pulsatile GnRH
Administered either intravenously or subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
Drug: Placebo Clomiphene Citrate
oral placebo clomiphene citrate for 5 days
|
|
Placebo Comparator: Placebo SC
Placebo Pulsatile GnRH (Lutrepulse®) administered subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks and oral placebo clomiphene citrate for 5 days
|
Drug: Placebo Pulsatile GnRH
Administered either intravenously or subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
Drug: Placebo Clomiphene Citrate
oral placebo clomiphene citrate for 5 days
|
|
Active Comparator: Clomiphene Citrate/Placebo IV
Oral clomiphene citrate (over encapsulated) for 5 days and Placebo Pulsatile GnRH (Lutrepulse®) administered intravenously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
|
Drug: Clomiphene Citrate
Oral clomiphene citrate (over encapsulated) for 5 days
Other Name: Clomid
Drug: Placebo Pulsatile GnRH
Administered either intravenously or subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
|
|
Active Comparator: Clomiphene Citrate / Placebo SC
Oral clomiphene citrate (over encapsulated) for 5 days and Placebo Pulsatile GnRH (Lutrepulse®) administered subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
|
Drug: Clomiphene Citrate
Oral clomiphene citrate (over encapsulated) for 5 days
Other Name: Clomid
Drug: Placebo Pulsatile GnRH
Administered either intravenously or subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
|
This multicenter, randomized, double-blind, placebo-controlled study will be performed in approximately 132 women with anovulatory/oligoovulatory infertility. The treatment duration will be approximately 4 weeks with pulsatile GnRH or placebo and 5 days with Clomiphene Citrate or placebo. All subjects will be screened based on inclusion/exclusion criteria, medical/infertility history and general safety assessments. Subjects that complete screening will be dispensed 100 mg of oral progesterone twice a day for 10 days to induce uterine bleeding. On Cycle Day 5 from the start of bleeding the subject will be randomly assigned to 1 of 7 treatment groups. All subjects will be monitored weekly throughout the 4 week treatment period for ovulation and intercourse will be timed. All subjects will be required to return to the study center for a total of 8 visits. In addition, all subjects with a confirmed clinical pregnancy will be monitored until fetal heartbeat is confirmed at approximately 5-6 weeks gestation
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations| United States, Louisiana | |
| Southern Fertility Center and Clinical Research | |
| Metairie, Louisiana, United States, 70002 | |
| Study Director: | Clinical Development Support | Ferring Pharmaceuticals |
More Information
| Responsible Party: | Clinical Development Support, Ferring Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00296465 History of Changes |
| Other Study ID Numbers: | 2004-05 |
| Study First Received: | February 23, 2006 |
| Last Updated: | May 18, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Infertility Genital Diseases, Male Genital Diseases, Female Citric Acid Clomiphene Hormones Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Chelating Agents |
Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Fertility Agents, Female Fertility Agents Reproductive Control Agents Selective Estrogen Receptor Modulators |