LutrePulse Hypogonadotropic Hypogonadism

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, hepa…