Multicenter, Open-label, Randomized Study to Evaluate Inhibition of Ovulation During Treatment With Three Transdermal Patch Formulations Containing 0.55 mg Ethinylestradiol (EE) and 2.10 mg Gestodene (GSD) or 0.35 mg EE and 0.67 mg GSD or 0.275 mg EE and 1.05 mg GSD in Healthy Young Female Volunteers Over a Period of 3 Treatment Cycles
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 173
- 主要终点
- Hoogland score to evaluate the inhibition of ovulation
研究概览
简要总结
The primary objective of this trial is to examine whether ovulation is suppressed after use of hormone patches containing different dosages of ethinyl estradiol (EE) and gestodene (GSD) for 3 treatment cycles. To this end, the blood levels of endogenous hormones (hormones produced by your body) will be measured and transvaginal ultrasound examinations will be conducted at regular intervals. In addition, the concentrations of the administered hormones EE and GSD in blood will be determined in regular intervals.
With regard to the tolerability of the hormone patches subjects will be asked regularly how they feel and blood pressure, pulse and body weight will be determined. In addition, blood and urine safety examinations will be conducted at defined timepoints.
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
- 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 female volunteers
- •age 18 - 35 years (smoker not older than 30 years, inclusive)
- •ovulatory pre-treatment cycle
排除标准
- •Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous or arterial thromboembolic disease)
- •Regular intake of medication other than Oral Contraception
- •Clinically relevant findings (blood pressure, physical and gynecological examination, laboratory examination)
研究组 & 干预措施
Arm 1
干预措施: Gestodene/EE Patch (BAY86-5016) (Drug)
Arm 2
干预措施: Gestodene/EE Patch (BAY86-5016) (Drug)
Arm 3
干预措施: Gestodene/EE Patch (BAY86-5016) (Drug)
结局指标
主要结局
Hoogland score to evaluate the inhibition of ovulation
时间窗: After 2 months
次要结局
- Blood level time course of gonadotropins i.e. follicle stimulating hormone (FSH) and luteinizing formone (LH) as well as steroid hormones estradiol and progesterone(After 2 months)
- Follicle size measured by transvaginal ultrasound examination(After 2 months)
- Pharmacokinetics of ethinyl estradiol (EE), gestodene (GSD) and sex hormone binding globuline (SHBG)(After 2 months)
