Clinical Pharmacological Study of NS75A for Healthy Adult Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Day of the LH surge
研究概览
简要总结
GnRH analogs are globally used for assisted reproduction in infertile patients. To date, in healthy female volunteers the pharmacokinetic and pharmacodynamic profiles of cetrorelix when administered in a single dose have been investigated in studies conducted using doses of 1, 3 and 5 mg. Studies performed in premenopausal female volunteers confirmed that cetrorelix rapidly suppresses luteinizing hormone (LH) and estradiol and shows dose-dependent prolongation of the duration of LH suppression. However, there have been few reports of studies of the relationship between the cetrorelix dosage and its effect on LH surge. In the present study, we investigated the effect of cetrorelix on LH surge when this drug was administered in single doses of 1, 2 and 3 mg.
详细描述
To evaluate that effect on LH surge, we investigated the efficacy of cetrorelix in delaying the start of the LH surge in comparison with the control menstrual cycle when saline was administered, and also examined the mode of disappearance of pulsatile LH secretion during the cetrorelix administration menstrual cycle.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •a BMI of 18 years old and <18 and 25 years old and >25
- •menstrual cycles was within the range of 25~31 days
排除标准
- •use of a drug (e.g., oral contraceptives, drugs for treatment of hyperprolactinemia, GnRH agonists, sex steroid hormones, psychoactive drugs, etc.)
- •serious disease of the endocrine system, liver, kidney, heart, lung, digestive system, etc.
- •a generalized drug allergy
研究组 & 干预措施
Cetrorelix 1 mg
干预措施: Cetrorelix (Drug)
Cetrorelix 2 mg
干预措施: Cetrorelix (Drug)
Cetrorelix 3 mg
干预措施: Cetrorelix (Drug)
结局指标
主要结局
Day of the LH surge
时间窗: Saline administration menstrual cycle, cetrorelix administration menstrual cycle
次要结局
- Serum LH concentrations(Saline administration menstrual cycle, cetrorelix administration menstrual cycle)