LutrePulse Hypogonadotropic Hypogonadism
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| ClinicalTrials.gov Identifier: NCT01976728 |
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Recruitment Status :
Completed
First Posted : November 6, 2013
Results First Posted : March 3, 2021
Last Update Posted : March 3, 2021
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Sponsor:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Ferring Pharmaceuticals
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Primary Amenorrhea With Hypogonadotropic Hypogonadism | 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: Gonadorelin acetate SC 20 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) | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 39 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating Three Doses of Subcutaneous Pulsatile GnRH Administered Via OmniPod Pump for Ovulation Induction in Female Subjects With Primary Amenorrhea With Hypogonadotropic Hypogonadism |
| Actual Study Start Date : | April 1, 2014 |
| Actual Primary Completion Date : | February 23, 2018 |
| Actual Study Completion Date : | February 23, 2018 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: LutrePulse 10 µg/pulse
Gonadorelin acetate 10 µg/pulse
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Drug: Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pump
Other Name: LutrePulse |
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Experimental: LutrePulse 15 µg/pulse
Gonadorelin acetate 15 µg/pulse
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Drug: Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
Other Name: LutrePulse |
|
Experimental: LutrePulse 20 µg/pulse
Gonadorelin acetate 20 µg/pulse
|
Drug: Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
Other Name: LutrePulse |
|
Placebo Comparator: Placebo
Placebo
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Drug: Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump) |
Primary Outcome Measures :
- Ovulation Rate [ Time Frame: 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 :
- Progesterone (P4) Levels [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Treatment Days 1 and Day 10 ]Mean FSH and LH levels on Day 1 and Day 10.
- Estradiol (E2) Serum Levels [ Time Frame: At treatment Day 1 and Day 10 ]E2 serum levels on Day 1 and Day 10.
- Type, Intensity, and Frequency of Adverse Events (AEs) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: From treatment Day 1 to end-of-trial, approximately 10 weeks ]Proportion of subjects reporting OHSS classified as mild, moderate, or severe.
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| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01976728
Locations
Show 35 study locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
| Study Director: | Global Clinical Compliance | Ferring Pharmaceuticals |
Study Documents (Full-Text)
Documents provided by Ferring Pharmaceuticals:
Documents provided by Ferring Pharmaceuticals:
Study Protocol [PDF] December 6, 2017
Statistical Analysis Plan [PDF] December 7, 2017
| Responsible Party: | Ferring Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01976728 |
| Other Study ID Numbers: |
000070 |
| First Posted: | November 6, 2013 Key Record Dates |
| Results First Posted: | March 3, 2021 |
| Last Update Posted: | March 3, 2021 |
| Last Verified: | January 2021 |
Additional relevant MeSH terms:
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Hypogonadism Amenorrhea Gonadal Disorders Endocrine System Diseases Menstruation Disturbances |
Pathologic Processes Prolactin Release-Inhibiting Factors Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |