LutrePulse Hypogonadotropic Hypogonadism

Completed · Phase 3 · Has a placebo group

Conditions studied: Primary Amenorrhea With Hypogonadotropic Hypogonadism

In brief

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

Key facts

Study ID

NCT01976728

Run by

Ferring Pharmaceuticals

People needed

39

Starts

2014-04-01

Expected to finish

2018-02-23

Last updated by the study team

2021-03-03

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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