A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of a Combination Oral Contraceptive Regimen (DR-102) for the Prevention of Pregnancy in Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,858
- 试验地点
- 62
- 主要终点
- All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule
研究概览
简要总结
This is an open-label, single treatment study. All subjects will receive 12 months of oral contraceptive therapy with DR-102. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a daily diary.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Sexually active at risk for pregnancy
- •Agreement to use study oral contraceptive therapy as their only method of birth control during the study
- •History of regular spontaneous menstrual cycles or withdrawal bleeding episodes
- •Others as dictated by protocol
排除标准
- •Any contraindication to the use of oral contraceptives
- •Pregnancy or plans to become pregnant in the next 14 months
- •Smoker and age greater than or equal to 35 years
- •Others as dictated by protocol
研究组 & 干预措施
DR-102
desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
干预措施: DR-102 (Drug)
结局指标
主要结局
All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule
时间窗: thirteen 28-day cycles
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or \> 7 days after stopping the combination desogestrel/ethinyl estradiol (DSG/EE) or ethinyl estradiol (EE) treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)\*(total number of pregnancies)\*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.
Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule
时间窗: thirteen 28-day cycles
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or \> 7 days after stopping the combination DSG/EE or EE treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)\*(total number of pregnancies)\*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.
Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule
时间窗: thirteen 28-day cycles
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or \> 7 days after stopping the combination DSG/EE or EE treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)\*(total number of pregnancies)\*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.
次要结局
- All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight(thirteen 28-day cycles)
- Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight(thirteen 28-day cycles)
- Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule(thirteen 28-day cycles)
- Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule(thirteen 28-day cycles)
- Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule(thirteen 28-day cycles)
- Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule(thirteen 28-day cycles)
- Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule(thirteen 28-day cycles)
- Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule(thirteen 28-day cycles)