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LutrePulse Hypogonadotropic Hypogonadism

NCT01976728 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2021-03-03

Study results available
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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

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)

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Global Clinical Compliance · Ferring Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-01
Primary Completion
2018-02-23
Completion
2018-02-23

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01976728 on ClinicalTrials.gov