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Summary

for females ages 18–40 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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

Official Title

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

Keywords

Primary Amenorrhea With Hypogonadotropic Hypogonadism Hypogonadism Amenorrhea

Eligibility

You can join if…

Open to females ages 18–40

  • 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

You CAN'T join if...

  • 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

Locations

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

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ferring Pharmaceuticals
ID
NCT01976728
Phase
Phase 3
Lead Scientist
Marcelle Cedars
Study Type
Interventional
Last Updated
February 5, 2018