At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 39 enrolled
Drug / intervention
Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pump +3 moredrug
Likely dose
Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pumpfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pump, Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump, and 2 other interventions for Primary Amenorrhea With Hypogonadotropic Hypogonadism. Completed, enrolled 39 participants across 35 sites in 2 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 2013
Enrollment StartApr 2014
Primary CompletionFeb 2018
TodayJul 2026
First PostedNov 6, 2013
Enrollment StartApr 1, 2014
Primary CompletionFeb 23, 2018
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 12.7 years ago
Interventions
Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pumpdrug
Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pumpdrug
Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pumpdrug
Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)drug