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Eligibility
for females ages 18 years to 40 years
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

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

Eligibility

You can join if…

Open to females ages 18 years to 40 years

  • 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

  • Fertility Treatment Center accepting new patients
    Tempe, Arizona, USA
  • Watching Over Mothers & Babies withdrawn
    Tucson, Arizona, USA
  • University of Colorado School of Medicine accepting new patients
    Aurora, Colorado, USA
  • Reproductive Associates of Delaware accepting new patients
    Newark, Delaware, USA
  • Columbia Fertility Associates accepting new patients
    Washington, District of Columbia, USA
  • Women's Medical Research Group, LLC accepting new patients
    Clearwater, Florida, USA
  • Center for Reproductive Medicine accepting new patients
    Orlando, Florida, USA
  • Georgia Reproductive Specialists accepting new patients
    Atlanta, Georgia, USA
  • Fertility Centers of Illinois accepting new patients
    Chicago, Illinois, USA
  • Cypress Medical Research Center accepting new patients
    Wichita, Kansas, USA
  • Bluegrass Clinical Research Inc. accepting new patients
    Louisville, Kentucky, USA
  • Maine Medical Center-REI accepting new patients
    Portland, Maine, USA
  • Massachusetts General Hospital terminated
    Boston, Massachusetts, USA
  • Wayne State University Physicians Group accepting new patients
    Southfield, Michigan, USA
  • Columbia University, Center for Menopause hormonal disorders and women's health withdrawn
    New York, New York, USA
  • Weill Cornell Medical College not yet accepting patients
    New York, New York, USA
  • Carolinas HealthCare System accepting new patients
    Charlotte, North Carolina, USA
  • Lyndhurst Clinical Research accepting new patients
    Winston Salem, North Carolina, USA
  • Wake Forest University Health Sciences accepting new patients
    Winston-Salem, North Carolina, USA
  • Institute for Reproductive Health accepting new patients
    Cincinnati, Ohio, USA
  • University of Cincinnati Physicians accepting new patients
    Cincinnati, Ohio, USA
  • UH Case Medical Center, MacDonald Clinical Trials accepting new patients
    Cleveland, Ohio, USA
  • Ohio Reproductive Medicine accepting new patients
    Columbus, Ohio, USA
  • University of Oklahoma Health Sciences Center, Abington IVF & Genetics, L.P. accepting new patients
    Oklahoma City, Oklahoma, USA
  • Abington Reproductive Medicine, PC accepting new patients
    Abington, Pennsylvania, USA
  • Main Line Fertility Center accepting new patients
    Bryn Mawr, Pennsylvania, USA
  • Penn State MS Hershey Medical Center, Penn State College of Medicine accepting new patients
    Hershey, Pennsylvania, USA
  • University of Pittsburgh, Magee-Womens Hospital not yet accepting patients
    Pittsburgh, Pennsylvania, USA
  • Fertility Associates of Memphis PLLC accepting new patients
    Memphis, Tennessee, USA
  • Center for Assisted Reproduction accepting new patients
    Bedford, Texas, USA
  • Houston Fertility Institute accepting new patients
    Houston, Texas, USA
  • Center of Reproductive Medicine accepting new patients
    Webster, Texas, USA
  • Utah Fertility Center accepting new patients
    Pleasant Grove, Utah, USA
  • Jones Institute for Reproductive Medicine accepting new patients
    Norfolk, Virginia, USA
  • Olive Fertility Centre accepting new patients
    Vancouver, British Columbia, Canada
  • Ovo accepting new patients
    Montreal, Quebec, Canada

Details

Status
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
October 2016
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