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NCT01976728 · ClinicalTrials.gov registry record · Phase 3
LutrePulse Hypogonadotropic Hypogonadism
A Phase 3 study of Primary Amenorrhea With Hypogonadotropic Hypogonadism, sponsored by Ferring Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 39
- Enrollment target
- 20
- Study locations
NCT01976728: Completed Phase 3 study of Primary Amenorrhea With Hypogonadotropic Hypogonadism, sponsored by Ferring Pharmaceuticals.
NCT01976728 is a Phase 3 study of Primary Amenorrhea With Hypogonadotropic Hypogonadism that has completed, run by Ferring Pharmaceuticals. The registered enrollment target is 39 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01976728, a Phase 3 study of Primary Amenorrhea With Hypogonadotropic Hypogonadism, has completed, sponsored by Ferring Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 39 participants
- Enrollment target
- 20
- Study locations
Study 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
Primary Outcome
Calculated as a proportion of subjects with at least 1 post-baseline progesterone level ≥ 6 ng/mL or subjects with confirmed positive serum β-human chorionic gonadotropin (β-hCG) (i.e., 2 positive results) or subjects with a gestational sac documented by transvaginal ultrasound (TVUS).
Conditions Studied
Interventions
- 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)
Study Locations (20)
North Carolina
- Carolinas HealthCare System - Charlotte
- Lyndhurst Clinical Research - Winston-Salem
- Wake Forest University Health Sciences - Winston-Salem
Florida
- Women's Medical Research Group, LLC - Clearwater
- Center for Reproductive Medicine - Orlando
Ohio
- Institute for Reproductive Health - Cincinnati
- University of Cincinnati Physicians - Cincinnati
Arizona
- Fertility Treatment Center - Tempe
California
- Center for Reproductive Health UCSF - San Francisco
Colorado
- University of Colorado School of Medicine - Aurora
Delaware
- Reproductive Associates of Delaware - Newark
District of Columbia
- Columbia Fertility Associates - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2014-04-01 |
| Est. Completion | 2018-02-23 |
| Phase | Phase 3 |
What the finished NCT01976728 record still lists
NCT01976728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Primary Amenorrhea With Hypogonadotropic Hypogonadism appearing as the primary indexed condition, and to 4 interventions - of which Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pump is the first listed.
NCT01976728 names 20 study sites across 16 states, led by North Carolina, Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT01976728 about?
NCT01976728 is a clinical study titled "LutrePulse Hypogonadotropic Hypogonadism". 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
What is the current status of trial NCT01976728?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 39 participants. The study started on 2014-04-01. Estimated completion is 2018-02-23.
What conditions does trial NCT01976728 study?
This clinical trial studies the following conditions: Primary Amenorrhea With Hypogonadotropic Hypogonadism.
What interventions are being tested in trial NCT01976728?
The interventions under investigation include: 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) (DRUG).
Who is sponsoring clinical trial NCT01976728?
This trial is sponsored by Ferring Pharmaceuticals, which has 83 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01976728 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Delaware, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01976728's enrollment target sits among peer trials
39 1898th of 2000 higher than 101 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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