NCT00456924已完成2 期
Prospective Randomized Multicenter Phase II Study of the Dose-Response Effects of Continuous Administration of Low-Dose VA2914 on Parameters of the Hypothalamic-Pituitary-Gonadal Axis and the Endometrium
HRA Pharma6 个研究点 分布在 2 个国家目标入组 48 人开始时间: 2004年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 6
- 主要终点
- ovarian hormones
研究概览
简要总结
The purpose of the present study is to evaluate continuous administration of low doses of VA2914 for potential contraceptive activity and effects on the menstrual cycle and steroid hormone parameters.
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
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women in good general health with regular, ovulatory menstrual cycles
- •age 18-35
- •not pregnant
- •not sexually active or reliably use barrier methods of contraception
- •normal liver and renal functions and normal laboratory exams
排除标准
- •pregnant or breastfeeding
- •oral contraception, IUD or other hormonal treatment
- •use of agents known to induce hepatic P450
- •cardiovascular disorder
- •hepatic, renal, or gastrointestinal disorder
- •metrorrhagia
- •abnormal transvaginal ultrasound (at baseline)
- •history of abnormal endometrial biopsy,
- •depression
- •mental illness
- •migraines
- •abnormal Pap Smear requiring further exploratory examination
- •anovulatory cycle before treatment
- •extreme overweight or underweight (body mass index < 16 ou >28)
- •subjects unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
- •use of narcotics
- •more than 10 cigarettes per day, more than 2 glasses of wine/beer per day
- •surgical procedures planned in the 6 months following screening visit
结局指标
主要结局
ovarian hormones
follicular development
endometrial histology
次要结局
- menstural bleeding patterns
- cervical mucus
- VA2914 concentration
- adverse events
- laboratory parameters
研究者
研究点 (6)
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