NCT00673686已完成2 期
Single Center, Double-blind, Randomized Study to Compare the Effect of SH T 00186 D on Follicular Development in a 24-day Regimen Versus a 21-day Regimen in Healthy Female Volunteers
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
- 105
- 主要终点
- Hoogland scores in cycles 2 and 3
研究概览
简要总结
In this study a comparison was made on the influence of missing pills on follicular ripening. By missing a given number of pills, an effect on "contraceptive robustness" of the two investigated contraceptive pills was measured by ultrasound comparison of follicular size and other parameters which indicate how far ovulation might be.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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 aged 18 to 35 years inclusive (smokers aged up to 30 years inclusive)
- •No contraindications for combined oral contraceptive (COC) use
- •Follicular diameter of greater-equal than 15 mm on visit 6 (admission to treatment), or an observed ovulation during pretreatment cycle
排除标准
- •Pregnancy or lactation- Substantial overweight, i.e., body mass index (BMI) > 30,
- •Known hypersensitivity to any of the study drug ingredients
- •Any disease that may worsen under hormonal treatment or might interfere with the conduct of the study, or the interpretation of the results
研究组 & 干预措施
Arm 1
Experimental
干预措施: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300) (Drug)
Arm 2
Active Comparator
干预措施: Yasminelle (SH T 00186 D) (Drug)
结局指标
主要结局
Hoogland scores in cycles 2 and 3
时间窗: Treatment cycles 2 and 3 (treatment weeks 5-12)
次要结局
- Follicle size(Treatment cycles 2 and 3 (treatment weeks 5-12)
- Hormone levels of progesterone, estradiol, luteinizing hormone, follicle stimulating hormone(Treatment cycles 2 and 3 (treatment weeks 5-12)
- Endometrial thickness(Treatment cycles 2 and 3 (treatment weeks 5-12)
- Cervical mucus(Treatment cycles 2 and 3 (treatment weeks 5-12)
研究者
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