LutrePulse Hypogonadotropic Hypogonadism
- Conditions
- Primary Amenorrhea With Hypogonadotropic Hypogonadism
- Interventions
- Drug: Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
- Registration Number
- NCT01976728
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 39
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LutrePulse 10 µg/pulse Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pump Gonadorelin acetate 10 µg/pulse LutrePulse 15 µg/pulse Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump Gonadorelin acetate 15 µg/pulse LutrePulse 20 µg/pulse Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump Gonadorelin acetate 20 µg/pulse Placebo Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump) Placebo
- Primary Outcome Measures
Name Time Method Ovulation Rate From treatment Day 1 up to 4 weeks after second positive β-hCG test, approximately 9 weeks Calculated as a proportion of subjects with at least 1 post-baseline progesterone level ≥ 6 ng/mL or subjects with confirmed positive serum β-human chorionic gonadotropin (β-hCG) (i.e., 2 positive results) or subjects with a gestational sac documented by transvaginal ultrasound (TVUS).
- Secondary Outcome Measures
Name Time Method Progesterone (P4) Levels Treatment Days 19, 21, 23, 25, and 27 Proportion of participants with at least 1 post-baseline P4 level ≥ 10 ng/mL.
Clinical Pregnancy Rate 2 to 4 weeks after a second positive serum β-hCG test Proportion of subjects with presence of gestational sac and fetal heart movement on TVUS after a second positive serum β-hCG test.
Biochemical Pregnancy Rate Approximately 14 days after LH surge Proportion of subjects with a confirmed positive serum β-hCG test after luteinizing hormone (LH) surge.
LH Surge Detection Daily from Day 11 until first positive LH surge or until Day 39 Proportion of subjects with a positive detection of LH surge, based on a Clearblue test which began when follicles with a mean diameter ≥14 mm were documented on TVUS.
Ovarian Follicular Development: Number of Follicles With a Mean Diameter Greater Than or Equal to (≥)14 mm From treatment Day 10 to treatment Day 21 Number of follicles with a mean diameter ≥14 mm collected from Days 10 or 11, until LH surge or Day 21.
Ovarian Follicular Development: Number of Dominant Follicles With a Mean Diameter of ≥18 mm From treatment Day 10 to treatment Day 21 Number of dominant follicles with a mean diameter ≥18 mm collected from Days 10 or 11, until LH surge or Day 21.
Luteal Phase Support: Maximum P4 Levels Treatment Days 19, 21, 23, 25, and 27 Maximum of post-dose P4 levels collected on treatment Days 19 to 27 are presented.
Luteal Phase Support: Mean P4 Levels Median post-dose P4 values across Treatment Days 19, 21, 23, 25, and 27 Mean of post-dose P4 levels collected on treatment Days 19 to 27 are presented.
Change From Baseline in Follicle-stimulating Hormone (FSH) Baseline (pre-dose), Treatment Day 1, Treatment Day 10 FSH change from baseline in relation to the first dose (pulse) on Day 1 and Day 10
Change From Baseline in LH Baseline (pre-dose), Treatment Day 1, Treatment Day 10 LH change from baseline in relation to first dose (pulse) on Day 1 and Day 10
Mean Serum FSH and LH Levels Treatment Days 1 and Day 10 Mean FSH and LH levels on Day 1 and Day 10.
Estradiol (E2) Serum Levels At treatment Day 1 and Day 10 E2 serum levels on Day 1 and Day 10.
Type, Intensity, and Frequency of Adverse Events (AEs) From treatment Day 1 to end-of-trial, approximately 10 weeks An AE was defined as any untoward medical occurrence in a subject taking part in a clinical trial. Proportion of subjects with any AE (serious or non-serious) and intensity of AEs (classified as mild, moderate or severe) are presented.
Hematology, Clinical Chemistry, and Urinalysis From treatment Day 1 to end-of-trial, approximately 10 weeks Proportion of subjects with markedly abnormal changes in hematology, clinical chemistry, and urinalysis.
Frequency and Severity of Ovarian Hyperstimulation Syndrome (OHSS) From treatment Day 1 to end-of-trial, approximately 10 weeks Proportion of subjects reporting OHSS classified as mild, moderate, or severe.
Trial Locations
- Locations (35)
Wayne State University Physicians Group
🇺🇸Southfield, Michigan, United States
Fertility Treatment Center
🇺🇸Tempe, Arizona, United States
Maine Medical Center-REI
🇺🇸Portland, Maine, United States
Jones Institute for Reproductive Medicine
🇺🇸Norfolk, Virginia, United States
Carolinas HealthCare System
🇺🇸Charlotte, North Carolina, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Main Line Fertility Center
🇺🇸Bryn Mawr, Pennsylvania, United States
Center for Assisted Reproduction
🇺🇸Bedford, Texas, United States
Center of Reproductive Medicine
🇺🇸Webster, Texas, United States
Cypress Medical Research Center
🇺🇸Wichita, Kansas, United States
Fertility Centers of Illinois
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, 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
Houston Fertility Institute
🇺🇸Houston, Texas, United States
Center for Reproductive Health UCSF
🇺🇸San Francisco, California, United States
Women's Medical Research Group, LLC
🇺🇸Clearwater, Florida, United States
UH Case Medical Center, MacDonald Clinical Trials
🇺🇸Cleveland, Ohio, United States
Reproductive Associates of Delaware
🇺🇸Newark, Delaware, United States
Ovo
🇨🇦Montreal, Quebec, Canada
Georgia Reproductive Specialists
🇺🇸Atlanta, Georgia, United States
University of Cincinnati Physicians
🇺🇸Cincinnati, Ohio, United States
Fertility Associates of Memphis PLLC
🇺🇸Memphis, Tennessee, United States
Columbia Fertility Associates
🇺🇸Washington, District of Columbia, United States
Abington Reproductive Medicine, PC
🇺🇸Abington, Pennsylvania, United States
Institute for Reproductive Health
🇺🇸Cincinnati, Ohio, United States
Utah Fertility Center
🇺🇸Pleasant Grove, Utah, United States
University of Pittsburgh, Magee-Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Penn State MS Hershey Medical Center, Penn State College of Medicine
🇺🇸Hershey, Pennsylvania, United States
Olive Fertility Centre
🇨🇦Vancouver, British Columbia, Canada
Center for Reproductive Medicine
🇺🇸Orlando, Florida, United States
Lyndhurst Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
University of Colorado School of Medicine
🇺🇸Aurora, Colorado, United States
Bluegrass Clinical Research Inc.
🇺🇸Louisville, Kentucky, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States