A Multicenter, Open, Randomized, Parallel Group Comparison to Assess the Safety and Efficacy of the Oral Contraceptive SH T00186D (0.02 mg Ethinylestradiol as Betadex Clathrate and 3 mg Drospirenone) in Two Variations of an Extended Regimen vs. a Standard Regimen (24 + 4 Days) in 1122 Healthy Female Volunteers for One Year, Followed by a One Year Safety Extension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,166
- 主要终点
- Number of Unintended Pregnancies in Yaz Flexible Arm
研究概览
简要总结
The purpose of the study is to determine safety and efficacy of long-cycle regimens of an oral contraceptive.
详细描述
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG (BSP AG), Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
The previously posted secondary Outcome Measure "Parameters of safety and tolerability" has been removed from result posting as it is covered by the Adverse Event section.
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 women who desire contraception
- •smokers ≤ 30 Years old
排除标准
- •Contraindication against use of hormonal contraceptives
研究组 & 干预措施
Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300)
3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
干预措施: Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300) (Drug)
Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300)
3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
干预措施: Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300) (Drug)
Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300)
13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
干预措施: Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300) (Drug)
结局指标
主要结局
Number of Unintended Pregnancies in Yaz Flexible Arm
时间窗: up to 2 years
Pregnancies with conception date within 4 days after end of study medication were regarded as during treatment.
Adjusted Pearl Index
时间窗: Up to 2 years
The adjusted Pearl Index was based on pregnancies due to method failures and compliant treatment cycles, i.e. cycle length between 24 and 124 day, pill break not longer than 7 days, and number of pills taken not smaller than 90% of the number of days in that cycle minus 7 days.
Pearl Index
时间窗: Up to 2 years
The Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 2-year PI was obtained by dividing the number of pregnancies that occurred during the two years of treatment by the time (in 100 women years) that the women were under risk of getting pregnant. 95% confidence interval according to European Medicine Agency Note for guidance on clinical investigation of steroid contraceptives in women.
Number of Days With Bleeding Including Spotting
时间窗: up to 1 year
The number of bleeding days per volunteer was calculated by summing up all days with bleeding intensity spotting or worse. The primary evaluation was the comparison of the flexible extended vs the standard regimen for this primary target variable, which was done for data within the first year of treatment only. As no further comparison or testing was done, no multiplicity issue arose.
Number of Unintended Pregnancies Due to Method Failure
时间窗: Up to 2 years
Not included in this analysis are pregnancies due to subject failure eg. non-compliance with tablet intake rules.
次要结局
- Number of Days With Bleeding Excluding Spotting(up to 1 year)
- Number of Bleeding Days During One Year of Treatment in Subjects With at Least 248 Days of Exposure Normalized to 372 Days(up to 1 year)
- Number of Bleeding / Spotting Episodes in 90 Day Reference Period(Up to one year)
- Days With Scheduled Versus Unscheduled Bleeding(Up to one year)
- Number of Bleeding / Spotting Days by 90-day Reference Period(up to 1 year)