A Prospective, Multicenter, Double-Blinded, Randomized Study to Evaluate Bleeding Patterns in Women Using One of Three Different Doses of DR-1031 Oral Contraceptive Compared to Seasonale Oral Contraceptive Regimen
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 567
- 试验地点
- 1
- 主要终点
- Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84)
研究概览
简要总结
This is a 4-arm study to evaluate and compare bleeding patterns between three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary
详细描述
This Phase 2, prospective, multicenter, double-blinded, randomized study is designed to evaluate and compare bleeding patterns in women using one of three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive.
Patients who meet all study entrance criteria will be randomly assigned to one of four treatment groups,
The overall study duration will be approximately 9 months; this will include a screening period of approximately 4 weeks, a run-in period of 4 weeks, a treatment period of approximately 6 months (two,91-day cycles) and a final study visit occurring 14-21 days after completion of study drug.
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
- Double (Participant, Investigator)
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
- •Premenopausal
- •Not pregnant or breastfeeding
- •Agree to use back-up non-hormonal contraception for study period
排除标准
- •Any contraindication to the use of oral contraceptives
- •Pregnancy within the last 3 months
- •Smoking >10 cigarettes per day
研究组 & 干预措施
Low Dose DR-1031
42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
干预措施: DR-1031 (Drug)
Low Dose DR-1031
42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
干预措施: Portia® (Drug)
Midrange Dose DR-1031
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
干预措施: DR-1031 (Drug)
Midrange Dose DR-1031
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
干预措施: Portia® (Drug)
High Dose DR-1031
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
干预措施: DR-1031 (Drug)
High Dose DR-1031
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
干预措施: Portia® (Drug)
Seasonale
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
干预措施: Seasonale® (Drug)
Seasonale
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
干预措施: Portia® (Drug)
结局指标
主要结局
Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84)
时间窗: Day 1-84
Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.
Days With Bleeding and/or Spotting During Active Cycle 2 (Day 92-176)
时间窗: Day 92-176
Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.
次要结局
- Days With Bleeding During Active Cycle 1 (Day 1-84)(Day 1-84)
- Days With Bleeding During Active Cycle 2 (Day 92-176)(Day 92-176)
- Time to First Bleeding Day(Day 1-84)
- Maximum Bleeding Severity During Active Cycle 1 (Day 1-84)(Day 1-84)
- Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 1 (Day 85-91)(Day 85-91)
- Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 2 (Day 177-183)(Day 177-183)
- Participants Reporting Hormone-Related Symptoms During Active Cycle 1 (Day 1-84)(Day 1-84)
- Participants Reporting Hormone-Related Symptoms During Active Cycle 2 (Day 92-176)(Day 92-176)
- Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 1 (Day 85-91)(Day 85-91)
- Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 2 (Day 177-183)(Day 177-183)