Phase 3
N=39
LutrePulse Hypogonadotropic Hypogonadism
Primary Amenorrhea With Hypogonadotropic Hypogonadism
Bottom Line
View on ClinicalTrials.gov: NCT01976728 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Ovulation Rate — 1; 4; 5; 9 Participants — p=0.0120
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 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) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ovulation Rate |
1; 4; 5; 9; 0 | 0.0120 sig |
| SECONDARY Progesterone (P4) Levels |
1; 4; 3; 7; 0 | 0.0553 |
| SECONDARY Clinical Pregnancy Rate |
0; 2; 5; 7; 0 | 0.0383 sig |
| SECONDARY Biochemical Pregnancy Rate |
0; 3; 5; 8; 0 | 0.0246 sig |
| SECONDARY LH Surge Detection |
3; 7; 6; 13; 0 | 0.0011 sig |
| SECONDARY Ovarian Follicular Development: Number of Follicles With a Mean Diameter Greater Than or Equal to (≥)14 mm |
0.0; 0.0; 0.0; 0.0; 0.0; 0.5 | 0.1344 |
| SECONDARY Ovarian Follicular Development: Number of Dominant Follicles With a Mean Diameter of ≥18 mm |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | 0.4142 |
| SECONDARY Luteal Phase Support: Maximum P4 Levels |
0.40; 2.40; 8.00; 0.30 | 0.6732 |
| SECONDARY Luteal Phase Support: Mean P4 Levels |
0.313; 1.440; 3.920; 0.233 | 0.7355 |
| SECONDARY Change From Baseline in Follicle-stimulating Hormone (FSH) |
1.30; 5.40; 2.70; 0.10; 0.04; -0.04 | 0.8772 |
| SECONDARY Change From Baseline in LH |
1.85; 7.90; 5.15; 0.05; 0.00; 0.58 | 0.1520 |
| SECONDARY Mean Serum FSH and LH Levels |
1.59; 1.47; 2.48; 1.35; 3.64; 6.20 | — |
| SECONDARY Estradiol (E2) Serum Levels |
36.50; 88.00; 81.00; 122.50; 106.00; 202.00 | 0.3147 |
| SECONDARY Type, Intensity, and Frequency of Adverse Events (AEs) |
5; 3; 4; 4; 5; 3 | — |
| SECONDARY Hematology, Clinical Chemistry, and Urinalysis |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Frequency and Severity of Ovarian Hyperstimulation Syndrome (OHSS) |
0; 0; 0; 0 | — |
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
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01976728). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.