A Prospective, Multicenter, Randomized, Double-Blind Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With the Oral Contraceptive Regimen DR-1021
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Serum Estradiol Levels by Cycle Day
研究概览
简要总结
This is a multi-center study to evaluate hormone levels with the oral contraceptive regimen DR-1021.
详细描述
Female volunteers, aged 18-35 years old who met all Inclusion and no Exclusion Criteria, were enrolled in this study. All participants were current users of a standard 21/7 oral contraceptive regimen (21 days of combination progestin/estrogen followed by 7 days placebo) and had completed at least one 28-day cycle prior to beginning the Cycle 1 baseline cycle. After completing screening, all enrolled participants continued to receive the same regimen of 150 μg DSG /20 μg EE combination pills once daily for 21 days followed by placebo once daily for 7 days during Cycle 1 (the Run-In phase). Following completion of Cycle 1, participants were randomly assigned to receive either DR-1021 or Mircette during Cycle 2. All participants who completed Cycle 2 were to receive Kariva during Cycle 3; however, participants were only followed for the first 21 days of this 28-day regimen, after which they were considered study completers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Premenopausal
- •Weight <200 lbs
- •Currently taking or willing to be treated with an oral contraceptive with a standard 21/7 regimen for one cycle prior to starting Study Cycle 1
- •Others as dictated by protocol
排除标准
- •Any contraindication to the use of oral contraceptives
- •Breast feeding
- •Smoking > 10 cigarettes per day
- •Use of drugs that require simultaneous use of contraceptives (e.g., isotretinoin [Accutane])
- •Others as dictated by protocol
研究组 & 干预措施
DR-1021
After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
干预措施: DR-1021 (Drug)
DR-1021
After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
干预措施: Kariva® (Drug)
Mircette
After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
干预措施: Mircette® (Drug)
Mircette
After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
干预措施: Kariva® (Drug)
结局指标
主要结局
Serum Estradiol Levels by Cycle Day
时间窗: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.
Levels of estradiol were measured throughout the study from blood samples.
Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day
时间窗: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.
Levels of follicle stimulating hormone were measured throughout the study from blood samples.
Serum Inhibin-B Levels by Cycle Day
时间窗: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.
Levels of inhibin-B were measured throughout the study from blood samples.
次要结局
- Percentage of Follicles Greater Than 5 mm in Diameter(Cycle 1, Days 11, 19-20, 23, 25, 27, Cycle 2, Days 4, 11, 19-20, 23, 25, 27, Cycle 3, Day 4.)
- Change From Cycle 2 Days 1 - 20 to Cycle 2 Days 21 - 28 in Maximum Follicle Size(Cycle 2, Days 1-20 and Cycle 2, Days 21-28)
- Number of Days of Bleeding During Unscheduled and Scheduled Study Periods(Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21)
- Number of Days of Bleeding or Spotting During Unscheduled and Scheduled Study Periods(Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21)
- Percentage of Participants With Bleeding or Spotting During Unscheduled and Scheduled Study Periods(Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21)
- Percentage of Participants With Bleeding During Unscheduled and Scheduled Study Periods(Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21)