A Multicenter, Open-label, Three-arm, Active-controlled Study to Assess the Efficacy and Safety of the Oral Contraceptive SH T00186D (0.02 mg Ethinyl Estradiol as Betadex Clathrate and 3 mg Drospirenone) in Two Flexible Extended Regimens and a Conventional Regimen of YAZ in 1756 Healthy Females for 1 Year
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,887
- 主要终点
- Pearl Index
研究概览
简要总结
The purpose of this study is to determine whether the study drug is safe and effective.
详细描述
The primary efficacy parameter is the number of observed unintended pregnancy during 1 year of treatment. Secondary efficacy parameter include bleeding parameters and menstrual related symptoms Safety parameters included assessment of adverse events, laboratory evaluations.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women between 18 and 45 requesting oral contraception. Smokers may not exceed 35 years of age.
排除标准
- •The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study.
研究组 & 干预措施
Flexible (extended) regimen no. 2 of EE20/DRSP (BAY86-5300)
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle 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: EE20/DRSP (BAY86-5300) (Drug)
Flexible (extended) regimen no. 1 of EE20/DRSP (BAY86-5300)
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, 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 124-day intended treatment cycle 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: EE20/DRSP (BAY86-5300) (Drug)
Conventional regimen 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 of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of tablets without active substance (together resulting in one cycle of 24+4 standard treatment). 13 withdrawal bleeding episodes during one year of treatment were expected.
干预措施: EE20/DRSP (YAZ, BAY86-5300) (Drug)
结局指标
主要结局
Pearl Index
时间窗: Up to 1 year
The Pearl Index (PI) is the number of pregnancies per 100 woman years. The PI is obtained by dividing the number of pregnancies during treatment (conception date on/after the 1st day of treatment and not later than last day of treatment +14 days) by the treatment exposure time (in 100 women years) that the women were under risk of getting pregnant. The Pearl Index was not calculated individually for either the Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) treatment arm, nor for the Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) treatment arm, because the low sample size in these treatment arms (approximately. 200 subjects per group) did not allow a reliable PI calculation of these groups alone.
次要结局
- Number of Bleeding Days (Including Spotting Days)(Up to 1 year)
- Number of Bleeding Days (Excluding Spotting Days)(Up to 1 year)
- Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 1.(Day 1 to Day 90)
- Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 2.(Day 91 to Day 180)
- Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 3(Day 181 to Day 270)
- Number of Days With Bleeding/ (Including and Excluding Spotting) Within 90-day Reference Period 4(Day 271 to Day 360)
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 1(Up to 1 year)
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 2(Up to 1 year)
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 3(Up to 1 year)
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 4(Up to 1 year)
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 5(Up to 1 year)
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 6(Up to 1 year)
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 7(Up to 1 year)
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 8(Up to 1 year)
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 9(Up to 1 year)
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 10(Up to 1 year)
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 11(Up to 1 year)
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 12(Up to 1 year)
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 13(Up to 1 year)
- Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 14(Up to 1 year)
- Number of Intracyclic Bleeding Days(Up to 1 year)
- Number of Scheduled and Unscheduled Bleeding Days(Up to 1 year)
- Length of Cycles(Up to 1 year)