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COMPLETED Phase 3

LutrePulse Hypogonadotropic Hypogonadism

NCT01976728 · View on ClinicalTrials.gov ↗

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

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

FieldValue
Enrollment Target 39 participants
Start Date 2014-04-01
Est. Completion 2018-02-23
Phase Phase 3

Sponsor

Ferring Pharmaceuticals

27 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01976728

The ClinicalTrials.gov registry entry for NCT01976728 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ferring Pharmaceuticals, which has 27 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01976728 reports 20 study locations spanning 16 distinct geographic areas — top geographies include North Carolina, Florida, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01976728?

This trial is sponsored by Ferring Pharmaceuticals, which has 27 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial