LutrePulse Hypogonadotropic Hypogonadism

Ferring

Status and phase: Completed; Phase 3

Conditions: Primary Amenorrhea With Hypogonadotropic Hypogonadism

Treatments: Drug: Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump; Drug: Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pump; Drug: Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump; Drug: Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01976728

000070

Details and patient eligibility

About

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

Enrollment: 39 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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39 participants in 4 patient groups, including a placebo group

LutrePulse 10 µg/pulse

Experimental group

Description:

Gonadorelin acetate 10 µg/pulse

Treatment:

Drug: Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pump

LutrePulse 15 µg/pulse

Experimental group

Description:

Gonadorelin acetate 15 µg/pulse

Treatment:

Drug: Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump

LutrePulse 20 µg/pulse

Experimental group

Description:

Gonadorelin acetate 20 µg/pulse

Treatment:

Drug: Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)