NCT00805415已完成2 期
Multicenter, Open-label, Randomized, Comparative Study to Evaluate Ovulation Inhibition With Two 4-phasic Oral Contraceptive Regimens Containing Estradiol Valerate and Dienogest Applied Daily for Three Cycles to 200 Healthy Female Volunteer
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
- 209
- 试验地点
- 2
- 主要终点
- Proportion of subjects with a Hoogland score of 5-6 (luteinized unruptured follicle [LUF] or ovulation)
研究概览
简要总结
The aim of the study is to investigate the ovulation inhibition of two 4-phasic oral contraceptive regimens.
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
- None
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 women willing to use non-hormonal methods of contraception
排除标准
- •Women with any contraindication for oral contraceptive use, for example but not limited to: presence or history of venous or arterial thrombotic / thrombembolic events, hypertension, presence or history of severe hepatic disease
研究组 & 干预措施
Arm 1
Experimental
干预措施: EV/DNG (Qlaira, BAY86-5027, SH T00658K) (Drug)
Arm 2
Experimental
干预措施: EV/DNG (SH T00658L) (Drug)
结局指标
主要结局
Proportion of subjects with a Hoogland score of 5-6 (luteinized unruptured follicle [LUF] or ovulation)
时间窗: Treatment cycles 2 and 3
次要结局
- Proportion of subjects with a Hoogland score of 5-6 (LUF or ovulation)(Treatment cycles 2 or 3)
- Measurements of endometrial thickness(Treatment cycles 2 and 3)
- Visibility of cervical mucus(Treatment cycles 2 and 3)
- Ovarian activity (Hoogland score)(Posttreatment cycle (only subjects from center 2)Treatment cycles 2 and 3)
- Measurements of follicle size(Treatment cycles 2 and 3)
- Measurements of hormone levels (follicle-stimulating hormone [FSH], luteinizing hormone [LH], progesterone and estradiol)(Treatment cycles 2 and 3)
- Compliance(Throughout whole study)
- Medical, surgical and medication history, concomitant medication, general physical and gynecological examination, cervical smear, pregnancy test, adverse events, safety laboratory determinations, cycle control, vital signs(Various timepoint throughout the study)
研究者
研究点 (2)
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