LutrePulse Hypogonadotropic Hypogonadism
Condition: Primary Amenorrhea With Hypogonadotropic Hypogonadism
MeSH terms: Hypogonadism; Amenorrhea
Intervention: 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)
Intervention MeSH terms: Prolactin Release-Inhibiting Factors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 39.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No

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
    

Eligibility criteria:

        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