A Randomized, Open-Label, Controlled, Multi-Center Trial to Evaluate the Contraceptive Efficacy, Cycle Control, Safety and Acceptability of NuvaRing® (SCH 900702) in Chinese Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 983
- 主要终点
- Pearl Index, by Treatment Group
研究概览
简要总结
This is a study to assess the effectiveness of NuvaRing® (SCH 900702) for the prevention of pregnancy in fertile Chinese women. The acceptability and safety of NuvaRing® will also be assessed and compared with that of Yasmin.
详细描述
The purpose of this study is to assess the contraceptive efficacy of NuvaRing in fertile Chinese women; to assess vaginal bleeding pattern (cycle control), general safety, and acceptability of NuvaRing; and to evaluate the NuvaRing's effect on dysmenorrhea.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Sexually active Chinese women, at risk for pregnancy and not planning to use condoms during trial medication use
- •Women in need for contraception and willing to use a hormonal contraceptive method for 13 cycles
- •Body mass index ≥18 and ≤29 kg/m^2
排除标准
- •Contraindications for contraceptive steroids
- •Abnormal cervical smear corresponding to indeterminate changes at screening
- •Clinically relevant abnormal laboratory result at screening as judged by the investigator.
研究组 & 干预措施
ENG-EE (NuvaRing)
Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
干预措施: ENG 120 µg + EE 15 µg intravaginal ring (Drug)
DRSP-EE
Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
干预措施: DRSP 3 mg + EE 30 µg (Drug)
结局指标
主要结局
Pearl Index, by Treatment Group
时间窗: Up to 1 year
Primary Efficacy Outcome measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure (one woman-year defined as a period of 365.25 days).
次要结局
- Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle(Up to 1 year)
- Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle(Up to 1 year)