NCT01976728已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 35
- 主要终点
- Ovulation Rate
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
LutrePulse 10 µg/pulse
Experimental
Gonadorelin acetate 10 µg/pulse
干预措施: Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pump (Drug)
LutrePulse 15 µg/pulse
Experimental
Gonadorelin acetate 15 µg/pulse
干预措施: Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump (Drug)
LutrePulse 20 µg/pulse
Experimental
Gonadorelin acetate 20 µg/pulse
干预措施: Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump) (Drug)
结局指标
主要结局
Ovulation Rate
时间窗: 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).
次要结局
- Biochemical Pregnancy Rate(Approximately 14 days after LH surge)
- Progesterone (P4) Levels(Treatment Days 19, 21, 23, 25, and 27)
- Clinical Pregnancy Rate(2 to 4 weeks after a second positive serum β-hCG test)
- LH Surge Detection(Daily from Day 11 until first positive LH surge or until Day 39)
- 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)
- Ovarian Follicular Development: Number of Dominant Follicles With a Mean Diameter of ≥18 mm(From treatment Day 10 to treatment Day 21)
- Luteal Phase Support: Maximum P4 Levels(Treatment Days 19, 21, 23, 25, and 27)
- Luteal Phase Support: Mean P4 Levels(Median post-dose P4 values across Treatment Days 19, 21, 23, 25, and 27)
- Change From Baseline in Follicle-stimulating Hormone (FSH)(Baseline (pre-dose), Treatment Day 1, Treatment Day 10)
- Change From Baseline in LH(Baseline (pre-dose), Treatment Day 1, Treatment Day 10)
- Mean Serum FSH and LH Levels(Treatment Days 1 and Day 10)
- Estradiol (E2) Serum Levels(At treatment Day 1 and Day 10)
- Type, Intensity, and Frequency of Adverse Events (AEs)(From treatment Day 1 to end-of-trial, approximately 10 weeks)
- Hematology, Clinical Chemistry, and Urinalysis(From treatment Day 1 to end-of-trial, approximately 10 weeks)
- Frequency and Severity of Ovarian Hyperstimulation Syndrome (OHSS)(From treatment Day 1 to end-of-trial, approximately 10 weeks)
研究者
研究点 (35)
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