NCT01976728

LutrePulse Hypogonadotropic Hypogonadism

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating Three Doses of Subcutaneous Pulsatile GnRH Administered Via OmniPod Pump for Ovulation Induction in Female Subjects With Primary Amenorrhea With Hypogonadotropic Hypogonadism

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

To compare the ovulation rate in women with primary amenorrhea with hypogonadotropic hypogonadism following pulsatile gonadotropin-releasing hormone (GnRH) treatment using the OmniPod pump versus placebo

Conditions

• Primary Amenorrhea With Hypogonadotropic Hypogonadism

Interventions

Type	Name	Description
DRUG	Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pump
DRUG	Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
DRUG	Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
DRUG	Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)

Timeline

• Start date: 2014-04-01
• Primary completion: 2018-02-23
• Completion: 2018-02-23
• First posted: 2013-11-06
• Last updated: 2021-03-03
• Results posted: 2021-03-03

Locations

35 sites across 2 countries: United States, Canada