NCT00915915已完成2 期
Multicenter, Open-label, Randomized Study to Evaluate Inhibition of Ovulation of Two Transdermal Patch Formulations Containing 0.55 mg Ethinylestradiol and Either 1.05 or 2.1 mg Gestodene 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
- 108
- 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
研究概览
简要总结
Investigation of two transdermal hormone patch formulations for contraception regarding inhibition of ovulation over a period of 3 treatment cycles in healthy young female volunteers
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
- •BMI: 18 BMI 30 kg/m²
- •Healthy female volunteers
- •Age 18-35 years (smoker not older than 30 years, inclusive)
- •Ovulatory pre-treatment cycle, at least 3 month since delivery
- •Abortion or lactation before the first screening examination
- •Willingness to use non-hormonal methods of contraception during entire study
排除标准
- •Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous/artial thromboembolic disease
- •Regular intake of medication other than OCs
- •Clinically relevant findings (blood pressure, physical and gynaecological examination, laboratory examination) anovulatory pre-treatment cycle
研究组 & 干预措施
Arm 1
Experimental
干预措施: Ethinylestradiol/Gestodene (BAY86-5016) (Drug)
Arm 2
Experimental
干预措施: Ethinylestradiol/Gestodene (BAY86-5016) (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
时间窗: 4 months
次要结局
- The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3(4 months)
- Pharmacokinetics of Ethinylestradiol (EE), Gestodene (GSD) and SHBG in treatment cycles 2 and 3(4 Months)
- Cervical effects (Insler Score) for determination of hormonal effects on the cervix and the cervical mucus during pre-treatment cycle and treatment cycle 3(4 Months)
- Course of gonadotropins (FSH, LH, P, E2)(4 months)
- Endometrial thickness and Follicle size(4 months)
研究者
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