A Phase II, Randomized, Double-blind, Placebo-controlled, Comparative Trial to Investigate the Optimal Dose of a Single Administration of Org 36286 (Corifollitropin Alfa) to Induce Monofollicular Ovulation in Women With WHO Group II Anovulatory Infertility
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 主要终点
- Participant Ovulation Rate in Monofollicular Cycles
研究概览
简要总结
The objectives of this trial were to investigate the feasibility and the optimal dose of a single administration of Org 36286 to induce monofollicular ovulation in women with WHO Group II anovulatory infertility and to assess the safety (including the absence of antibody formation) of Org 36286.
详细描述
This was a phase II, randomized, double-blind, placebo controlled, comparative trial to investigate the optimal dose of a single administration of Org 36286 to induce monofollicular ovulation in women with WHO Group II anovulatory infertility.
Treatment injection was given on Day 1-3 after the onset of a spontaneous or progestagen induced withdrawal bleeding. After injection, ultrasound monitoring and sampling for serum hormones were done on treatment Days 3, 5, and daily from Day 7 to 21 or until a urinary luteinizing hormone (LH) peak was detected. From treatment Day 7 the urinary LH response was assessed to detect the preovulatory LH peak. In case of hyperstimulation, production of endogenous gonadotropins could be suppressed by giving daily injections of GnRH antagonist.
Post-treatment assessments were done in the third week after the urinary LH peak. If no LH peak was detected, posttreatment assessments were performed four to five weeks after Org 36286 or placebo injection.
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 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Wish to conceive;
- •Oligomenorrhea (cycle length >=41 days) or amenorrhea (no menstrual cycle for >6 months);
- •Body Mass Index (BMI) >=18 and <=32 kg/m^2;
- •Serum FSH levels within normal limits (1-10 IU/L);
- •Normal serum prolactin and thyroid stimulating hormone (TSH) levels;
- •Progestagen induced withdrawal bleeding or spontaneous menstrual bleeding;
排除标准
- •Tumours of the ovary, breast, uterus, pituitary or hypothalamus;
- •Pregnancy or lactation;
- •Undiagnosed vaginal bleeding;
- •Ovarian cysts or enlarged ovaries not related to polycystic ovarian disease (PCOD);
- •Any ovarian and/or abdominal abnormality interfering with ultrasound examination;
- •Malformations of the sexual organs incompatible with pregnancy;
- •Clomiphene resistance with documented anovulation (treated with 150 mg clomiphene for five days and no ovulation);
- •Treatment with metformin, gonadotropins, or GnRH analogs within 90 days prior to the start of Org 36286 treatment;
- •Treatment with clomiphene citrate within 42 days prior to the start of Org 36286 treatment;
- •Alcohol or drug abuse within the 12 months preceding signing of informed consent;
- •Any clinically relevant abnormal laboratory value;
- •Hypersensitivity to any of the substances in Org 36286;
- •Hypersensitivity to Orgalutran® or any of its components;
- •Use of any investigational drugs during 90 days before screening or previous participation in this trial.
研究组 & 干预措施
Org 36286 7.5 µg
Org 36286 7.5 µg administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later.
干预措施: Org 36286 (Drug)
Org 36286 15 µg
Org 36286 15 µg administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later.
干预措施: Org 36286 (Drug)
Org 36286 30 µg
Org 36286 30 µg administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later.
干预措施: Org 36286 (Drug)
Org 36286 60 µg
Org 36286 60 µg administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later.
干预措施: Org 36286 (Drug)
Placebo
Placebo to Org 36286 administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later.
干预措施: Placebo (Drug)
结局指标
主要结局
Participant Ovulation Rate in Monofollicular Cycles
时间窗: Up to 2 Weeks Following LH Peak
次要结局
- Participant Overall Ovulation Rate(Up to 2 Weeks Following LH Pek)
- Number of Participants With Cancellation of Menstrual Cycle(Up to Day 21)
- Participant Follicle Size(Up to Day 21)
- Number of Participants With Miscarriages, Biochemical, Ectopic, Clinical, Vital, Single, or Multiple Ongoing Pregnancies(Up to 10 Weeks Following Ovulation)
- Number of Participants Experiencing Serious Adverse Events (SAEs)(Up to 10 Weeks Following Ovulation)
- Number of Participants With Antibodies to Org 36286(Up to 3 Weeks Following Ovulation)
- Participant Serum Follicle Stimulating Hormone (FSH) Level(Up to Day 21)
- Participant Serum LH Level(Up to Day 21)
- Number of Participants With Clinically Significant Laboratory Abnormalities(Up to 3 Weeks Following Ovulation)
- Number of Participants With Clinically Significant Changes in Vital Signs(Up to 3 Weeks Followiing Ovulation)
- Participant Inhibin-B, E2, and P Serum Concentration(Up to Day 21)
- Number of Participants with Ovarian Hyperstimulation Syndrome (OHSS)(Up to 2 Weeks Following LH Peak)