drugset / Trial / NCT01976728
LutrePulse Hypogonadotropic Hypogonadism
RandomizedParallel-groupDouble-blindTreatment
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
Timeline
- Start
- 2014-04-01
- Primary completion
- 2018-02-23
- Completion
- 2018-02-23
Outcome
Met primary endpoint
registry analysis (superiority test); Lutrepulse 15 μg/Pulse and 20 μg/Pulse Pooled vs Placebo; p = 0.0120; Fisher Exact; NCT01976728 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gonadorelin | Protein / enzyme biologic | 10 ug | Subcutaneous |
| Subject | Gonadorelin | Protein / enzyme biologic | 15 ug | Subcutaneous |
| Subject | Gonadorelin | Protein / enzyme biologic | 20 ug | Subcutaneous |