Multicenter, Open-label, Uncontrolled Study to Investigate Suppression of Ovarian Activity of a Transdermal Contraceptive Patch Containing 0.55 mg Ethinyl Estradiol and 2.1 mg Gestodene in 80 Young Female Volunteers Over 3 Treatment Cycles
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 91
- 主要终点
- Suppression of ovulatory activity proved by progesterone and estradiol concentrations
研究概览
简要总结
The purpose of this study is to look into the effectiveness of a new investigational medication applied as a transdermal patch. The patch is applied on the skin with study medication that is absorbed through the skin suppressing ovarian activity and therefore preventing an egg from leaving an ovary (ovulation). The study will look into the study drug's safety and how well it is tolerated and its absorption, breakdown and elimination in the body. It describes how the body affects a specific drug after administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 subjects requesting contraception
- •Aged 18 to 35 years (inclusive); smokers must not be older than 30 years
- •Normal or clinically insignificant cervical smear not requiring further follow-up
- •History of regular cyclic menstrual periods
- •Willingness to use nonhormonal methods of contraception during the entire study
- •Proven ovulation upon completion of the pretreatment cycle
排除标准
- •Pregnancy or lactation
- •Obesity (body mass index [BMI] > 30.0 kg/m2)
- •Significant skin reaction to transdermal preparations or sensitivity to surgical/medical tape
- •Any disease or condition that may worsen under hormonal treatment
- •Use of hormonal contraception other than study medication during the study
研究组 & 干预措施
Gestodene/EE Patch
干预措施: Gestodene/EE Patch (BAY86-5016) (Drug)
结局指标
主要结局
Suppression of ovulatory activity proved by progesterone and estradiol concentrations
时间窗: Treatment day 29 to day 84
Estradiol levels \> 100pmol/L indicate some ovarian activity and progesterone levels \> 5nmol/L in subjects with estradiol levels \> 100pmol/L reflect ovulation or luteinized unruptured follicles.
次要结局
- Serum concentration, AUC (area under curve) of Gestodene(Multiple time points up to treatment day 84)
- Number of patients with abnormal safety laboratory(Up to 84 days)
- Number of patients with adverse events(Up to 84 days)
- Time course of luteinizing hormone(Day 27 of pretreatment cycle to treatment day 83)
- Serum concentration, AUC (area under curve) of ethinyl estradiol(Multiple time points up to treatment day 84)
- Serum concentration, AUC (area under curve) of Sexual hormone binding globulin(Multiple time points up to treatment day 84)
- Time course of follicle-stimulating hormone(Day 27 of pretreatment cycle to treatment day 83)