NCT00296465 - A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH | Biotech Hunter

Enrollment

132

Participants

Timeline

Start Date

February 28, 2005

Primary Completion Date

November 30, 2005

Study Completion Date

November 30, 2005

Conditions

InFertility

Interventions

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

DRUG

Clomiphene Citrate

Oral clomiphene citrate (over encapsulated) 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

Trial Locations (1)

70002

Southern Fertility Center and Clinical Research, Metairie