NCT00631124已完成2 期
A Double-blind, Randomized, Uncontrolled Study to Evaluate Inhibition of Ovulation of Two Oral Estradiol / Drospirenone Regimens in Healthy Young Female Volunteers Over a Period of 3 Treatment Cycles
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 103
- 主要终点
- The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3, based on the binary variable ovulation (i.e. Hoogland score 6) with the levels yes and no
研究概览
简要总结
Investigation of a new pill containing an estrogen and a progestin in order to monitor the inhibition of the ovulation in young healthy females over 3 treatment cycles
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •Healthy female volunteers,
- •Age 18 - 35 years
排除标准
- •Contraindications for use of a combined (estrogen/progestogen) contraceptive (e.g. history of venous/arterial thromboembolic disease)
- •Regular intake of medication
- •Clinically relevant findings (ECG, blood pressure, physical, gynecological examination, laboratory examination)
- •Anovulatory pre-treatment cycle
研究组 & 干预措施
Arm 1
Experimental
干预措施: BAY86-4891 (Estradiol / Drospirenone) (Drug)
Arm 2
Experimental
干预措施: BAY86-4891 (Estradiol / Drospirenone) (Drug)
结局指标
主要结局
The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3, based on the binary variable ovulation (i.e. Hoogland score 6) with the levels yes and no
时间窗: 12 months
次要结局
- Assessment of ovarian activity in treatment cycles 2 and 3(12 months)
- Endometrial growth(12 months)
- Pharmacokinetics of estrogen and progestin in treatment cycle 3(12 months)
- Course of gonadotropins (FSH, LH)(12 months)
研究者
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