LutrePulse Hypogonadotropic Hypogonadism

February 9, 2021 updated by: Ferring Pharmaceuticals

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Olive Fertility Centre
    • Quebec
      • Montreal, Quebec, Canada
        • Ovo
  • United States
    • Arizona
      • Tempe, Arizona, United States
        • Fertility Treatment Center
    • California
      • San Francisco, California, United States
        • Center for Reproductive Health UCSF
    • Colorado
      • Aurora, Colorado, United States
        • University of Colorado School of Medicine
    • Delaware
      • Newark, Delaware, United States
        • Reproductive Associates of Delaware
    • District of Columbia
      • Washington, District of Columbia, United States
        • Columbia Fertility Associates
    • Florida
      • Clearwater, Florida, United States
        • Women's Medical Research Group, LLC
      • Orlando, Florida, United States
        • Center for Reproductive Medicine
    • Georgia
      • Atlanta, Georgia, United States
        • Georgia Reproductive Specialists
    • Illinois
      • Chicago, Illinois, United States
        • Fertility Centers of Illinois
    • Kansas
      • Wichita, Kansas, United States
        • Cypress Medical Research Center
    • Kentucky
      • Louisville, Kentucky, United States
        • Bluegrass Clinical Research Inc.
    • Maine
      • Portland, Maine, United States
        • Maine Medical Center-REI
    • Massachusetts
      • Boston, Massachusetts, United States
        • Massachusetts General Hospital
    • Michigan
      • Southfield, Michigan, United States
        • Wayne State University Physicians Group
    • New York
      • New York, New York, United States
        • Weill Cornell Medical College
    • North Carolina
      • Charlotte, North Carolina, United States
        • Carolinas Healthcare System
      • Winston-Salem, North Carolina, United States
        • Wake Forest University Health Sciences
      • Winston-Salem, North Carolina, United States
        • Lyndhurst Clinical Research
    • Ohio
      • Cincinnati, Ohio, United States
        • Institute for Reproductive Health
      • Cincinnati, Ohio, United States
        • University of Cincinnati Physicians
      • Cleveland, Ohio, United States
        • UH Case Medical Center, MacDonald Clinical Trials
      • Columbus, Ohio, United States
        • Ohio Reproductive Medicine
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • University of Oklahoma Health Sciences Center, Abington IVF & Genetics, L.P.
    • Pennsylvania
      • Abington, Pennsylvania, United States
        • Abington Reproductive Medicine, PC
      • Bryn Mawr, Pennsylvania, United States
        • Main Line Fertility Center
      • Hershey, Pennsylvania, United States
        • Penn State MS Hershey Medical Center, Penn State College of Medicine
      • Pittsburgh, Pennsylvania, United States
        • University of Pittsburgh, Magee-Womens Hospital
    • Tennessee
      • Memphis, Tennessee, United States
        • Fertility Associates of Memphis PLLC
    • Texas
      • Bedford, Texas, United States
        • Center for Assisted Reproduction
      • Houston, Texas, United States
        • Houston Fertility Institute
      • Webster, Texas, United States
        • Center of Reproductive Medicine
    • Utah
      • Pleasant Grove, Utah, United States
        • Utah Fertility Center
    • Virginia
      • Norfolk, Virginia, United States
        • Jones Institute for Reproductive Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women 18-40 years old
  • Body mass index (BMI) between 18 and 38 kg/m2
  • Clinical history or recently diagnosed with primary amenorrhea with hypogonadotropic hypogonadism
  • Hormonal values in a centrally analyzed fasting blood sample: FSH <5 IU/L and mean LH <5 IU/L
  • Desire to become pregnant
  • Discontinued estrogen-progesterone replacement therapy at least 1 month before screening
  • Negative progestin challenge test performed during screening
  • PAP smear within 24 months of the initial visit
  • Normal or stable CT scan or MRI scan of the hypothalamic pituitary region
  • Prolactin and thyroid-stimulating hormone (TSH) within normal clinical laboratory limits
  • Male partner with normal semen analysis, including volume, liquefaction time, sperm count, and motility, according to the local laboratory normal criteria, within the past year
  • Normal transvaginal ultrasound at screening with respect to uterus and adnexa (presence of both ovaries and tubes, without evidence of clinically significant abnormality) and with normal uterine cavity and normal cervix
  • Tube patency on saline tubal perfusion, hysterosalpingography or laparoscopy on file within the past 2 years

Exclusion Criteria:

  • Any medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the drug
  • A history of, or currently diagnosed with clinically important cardiovascular, pulmonary (e.g. serious corticosteroid-dependent asthma), gastrointestinal, hepatic, metabolic, renal, endocrinological (e.g. insulin dependent diabetes mellitus), or neurological (e.g. epilepsy, serious migraine, central nervous system (CNS) lesions (in cases where hypogonadotropic hypogonadism is secondary to a CNS lesion or its treatment) abnormality
  • A history of adrenal or uncontrolled thyroid disorders, or hyperprolactinemia
  • Prior treatment cycle with gonadotropins or GnRH within the last 2 months
  • Known allergy to study drug or its components
  • Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C
  • Ovarian enlargement or cyst of unknown etiology
  • Abnormal gynecological bleeding of undetermined origin
  • Previous or current hormone-dependent tumor
  • Known active substance abuse
  • Planning to undergo in vitro fertilization procedure in the course of a study treatment cycle
  • Currently undergoing treatment with gonadotropin hormones (FSH and LH), psychotropic medication, sex hormones, or any other medication known to interfere with normal reproductive function or that can affect GnRH secretion (e.g. neuroleptics, dopamine antagonists, spironolactone, levodopa, phenothiazine, digoxin)
  • Ongoing pregnancy or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
Experimental: LutrePulse 10 µg/pulse
Gonadorelin acetate 10 µg/pulse
Drug: Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pump
Other Names:
  • LutrePulse
Experimental: LutrePulse 15 µg/pulse
Gonadorelin acetate 15 µg/pulse
Drug: Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
Other Names:
  • LutrePulse
Experimental: LutrePulse 20 µg/pulse
Gonadorelin acetate 20 µg/pulse
Drug: Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
Other Names:
  • LutrePulse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ovulation Rate
Time Frame: From treatment Day 1 up to 4 weeks after second positive β-hCG test, approximately 9 weeks
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).
From treatment Day 1 up to 4 weeks after second positive β-hCG test, approximately 9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progesterone (P4) Levels
Time Frame: Treatment Days 19, 21, 23, 25, and 27
Proportion of participants with at least 1 post-baseline P4 level ≥ 10 ng/mL.
Treatment Days 19, 21, 23, 25, and 27
Clinical Pregnancy Rate
Time Frame: 2 to 4 weeks after a second positive serum β-hCG test
Proportion of subjects with presence of gestational sac and fetal heart movement on TVUS after a second positive serum β-hCG test.
2 to 4 weeks after a second positive serum β-hCG test
Biochemical Pregnancy Rate
Time Frame: Approximately 14 days after LH surge
Proportion of subjects with a confirmed positive serum β-hCG test after luteinizing hormone (LH) surge.
Approximately 14 days after LH surge
LH Surge Detection
Time Frame: Daily from Day 11 until first positive LH surge or until Day 39
Proportion of subjects with a positive detection of LH surge, based on a Clearblue test which began when follicles with a mean diameter ≥14 mm were documented on TVUS.
Daily from Day 11 until first positive LH surge or until Day 39
Ovarian Follicular Development: Number of Follicles With a Mean Diameter Greater Than or Equal to (≥)14 mm
Time Frame: From treatment Day 10 to treatment Day 21
Number of follicles with a mean diameter ≥14 mm collected from Days 10 or 11, until LH surge or Day 21.
From treatment Day 10 to treatment Day 21
Ovarian Follicular Development: Number of Dominant Follicles With a Mean Diameter of ≥18 mm
Time Frame: From treatment Day 10 to treatment Day 21
Number of dominant follicles with a mean diameter ≥18 mm collected from Days 10 or 11, until LH surge or Day 21.
From treatment Day 10 to treatment Day 21
Luteal Phase Support: Maximum P4 Levels
Time Frame: Treatment Days 19, 21, 23, 25, and 27
Maximum of post-dose P4 levels collected on treatment Days 19 to 27 are presented.
Treatment Days 19, 21, 23, 25, and 27
Luteal Phase Support: Mean P4 Levels
Time Frame: Median post-dose P4 values across Treatment Days 19, 21, 23, 25, and 27
Mean of post-dose P4 levels collected on treatment Days 19 to 27 are presented.
Median post-dose P4 values across Treatment Days 19, 21, 23, 25, and 27
Change From Baseline in Follicle-stimulating Hormone (FSH)
Time Frame: Baseline (pre-dose), Treatment Day 1, Treatment Day 10
FSH change from baseline in relation to the first dose (pulse) on Day 1 and Day 10
Baseline (pre-dose), Treatment Day 1, Treatment Day 10
Change From Baseline in LH
Time Frame: Baseline (pre-dose), Treatment Day 1, Treatment Day 10
LH change from baseline in relation to first dose (pulse) on Day 1 and Day 10
Baseline (pre-dose), Treatment Day 1, Treatment Day 10
Mean Serum FSH and LH Levels
Time Frame: Treatment Days 1 and Day 10
Mean FSH and LH levels on Day 1 and Day 10.
Treatment Days 1 and Day 10
Estradiol (E2) Serum Levels
Time Frame: At treatment Day 1 and Day 10
E2 serum levels on Day 1 and Day 10.
At treatment Day 1 and Day 10
Type, Intensity, and Frequency of Adverse Events (AEs)
Time Frame: From treatment Day 1 to end-of-trial, approximately 10 weeks
An AE was defined as any untoward medical occurrence in a subject taking part in a clinical trial. Proportion of subjects with any AE (serious or non-serious) and intensity of AEs (classified as mild, moderate or severe) are presented.
From treatment Day 1 to end-of-trial, approximately 10 weeks
Hematology, Clinical Chemistry, and Urinalysis
Time Frame: From treatment Day 1 to end-of-trial, approximately 10 weeks
Proportion of subjects with markedly abnormal changes in hematology, clinical chemistry, and urinalysis.
From treatment Day 1 to end-of-trial, approximately 10 weeks
Frequency and Severity of Ovarian Hyperstimulation Syndrome (OHSS)
Time Frame: From treatment Day 1 to end-of-trial, approximately 10 weeks
Proportion of subjects reporting OHSS classified as mild, moderate, or severe.
From treatment Day 1 to end-of-trial, approximately 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

February 23, 2018

Study Completion (Actual)

February 23, 2018

Study Registration Dates

First Submitted

October 15, 2013

First Submitted That Met QC Criteria

October 30, 2013

First Posted (Estimate)

November 6, 2013

Study Record Updates

Last Update Posted (Actual)

March 3, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000070

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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