Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ferring Pharmaceuticals
Age
18–40
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | LutrePulse Hypogonadotropic Hypogonadism
