Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
39 participants
INTERVENTIONAL
2014-04-01
2018-02-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LutrePulse 10 µg/pulse
Gonadorelin acetate 10 µg/pulse
Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pump
LutrePulse 15 µg/pulse
Gonadorelin acetate 15 µg/pulse
Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
LutrePulse 20 µg/pulse
Gonadorelin acetate 20 µg/pulse
Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
Placebo
Placebo
Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
Interventions
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Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pump
Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
FEMALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Compliance
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Fertility Treatment Center
Tempe, Arizona, United States
Center for Reproductive Health UCSF
San Francisco, California, United States
University of Colorado School of Medicine
Aurora, Colorado, United States
Reproductive Associates of Delaware
Newark, Delaware, United States
Columbia Fertility Associates
Washington D.C., District of Columbia, United States
Women's Medical Research Group, LLC
Clearwater, Florida, United States
Center for Reproductive Medicine
Orlando, Florida, United States
Georgia Reproductive Specialists
Atlanta, Georgia, United States
Fertility Centers of Illinois
Chicago, Illinois, United States
Cypress Medical Research Center
Wichita, Kansas, United States
Bluegrass Clinical Research Inc.
Louisville, Kentucky, United States
Maine Medical Center-REI
Portland, Maine, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Wayne State University Physicians Group
Southfield, Michigan, United States
Weill Cornell Medical College
New York, New York, United States
Carolinas HealthCare System
Charlotte, North Carolina, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Institute for Reproductive Health
Cincinnati, Ohio, United States
University of Cincinnati Physicians
Cincinnati, Ohio, United States
UH Case Medical Center, MacDonald Clinical Trials
Cleveland, Ohio, United States
Ohio Reproductive Medicine
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center, Abington IVF & Genetics, L.P.
Oklahoma City, Oklahoma, United States
Abington Reproductive Medicine, PC
Abington, Pennsylvania, United States
Main Line Fertility Center
Bryn Mawr, Pennsylvania, United States
Penn State MS Hershey Medical Center, Penn State College of Medicine
Hershey, Pennsylvania, United States
University of Pittsburgh, Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
Fertility Associates of Memphis PLLC
Memphis, Tennessee, United States
Center for Assisted Reproduction
Bedford, Texas, United States
Houston Fertility Institute
Houston, Texas, United States
Center of Reproductive Medicine
Webster, Texas, United States
Utah Fertility Center
Pleasant Grove, Utah, United States
Jones Institute for Reproductive Medicine
Norfolk, Virginia, United States
Olive Fertility Centre
Vancouver, British Columbia, Canada
Ovo
Montreal, Quebec, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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000070
Identifier Type: -
Identifier Source: org_study_id
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