NCT00461305已完成2 期
A Multicenter, Single-blind, Randomized Study, to Investigate Efficacy of Ethinylestradiol for Intracyclic Bleeding Profile During 24 Weeks (6 Cycles) by Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg and Drospirenone 3 mg/ Ethinylestradiol 30 µg in Patients With Dysmenorrheal and to Investigate the Long Term Safety Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg Administered for 52 Weeks (13 Cycles)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 420
- 主要终点
- Number of Participants With Intracyclic Bleeding at Cycle 6
研究概览
简要总结
The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic bleeding profile in patients with dysmenorrhea and to investigate the long term safety
详细描述
The "drospirenone 3 mg/ethinylestradiol 20 μg (13 cycles)" group is to be treated by oral administration for 52 weeks, 13 cycles. The "drospirenone 3 mg/ethinylestradiol 30 μg (6 cycles)" group is to be treated by oral administration for 24 weeks, 6 cycles.
The trial is sponsored by Bayer Yakuhin, Ltd.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20 years or older at obtaining informed consent
- •Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before the final enrollment
- •Patients having a total dysmenorrheal score of at least 3 points in twice of the latest menstruation before the final enrollment
排除标准
- •Patients with ovarian chocolate cysts
- •Patients with fibroid needed to be treated
- •Patients with estrogen-dependent tumors and patients with cervical cancer or suspected cervical cancer
- •Patients with undiagnosed abnormal vaginal bleeding
- •Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease, or coronary artery disease or a history of those diseases
- •Patients aged 35 years or older who smoke at least 15 cigarettes per day
- •Patients with migraine accompanied by prodromata
- •Patients with pulmonary hypertension or valvular heart disease
- •Patients who are regularly taking nutritional products that contain St. John's Wort
- •Patients who underwent surgical treatment for endometriosis within 2 months prior to screening
- •Patients who may need to regularly use analgesics for therapeutic objectives other than relief from the pain of dysmenorrhea during this study (occasional use permitted)
研究组 & 干预措施
DRSP 3 mg/EE 20 µg (13 cycles)
Experimental
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
干预措施: DRSP 3 mg/EE 20 µg (13 cycles) (Drug)
DRSP 3 mg/EE 30 µg (6 cycles)
Experimental
1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
干预措施: DRSP 3 mg/EE 30 µg (6 cycles) (Drug)
结局指标
主要结局
Number of Participants With Intracyclic Bleeding at Cycle 6
时间窗: Up to Cycle 6 (168 days) with 28 days per cycle
Intracyclic bleedings were defined as bleedings while a participant takes active tablets.
次要结局
- Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6(From baseline up to Cycle 6 (168 days) with 28 days per cycle)
- Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13(From baseline up to Cycle 13 (364 days) with 28 days per cycle)
- Distribution of Total Dysmenorrhea Score at Cycle 6(Up to Cycle 6 (168 days) with 28 days per cycle)
- Distribution of Total Dysmenorrhea Score at Cycle 13(Up to Cycle 13 (364 days) with 28 days per cycle)
- Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6(Up to Cycle 6 (168 days) with 28 days per cycle)
- Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13(Up to Cycle 13 (364 days) with 28 days per cycle)
- Distribution of Severity of Lumbago During Menstruation at Cycle 6(Up to Cycle 6 (168 days) with 28 days per cycle)
- Distribution of Severity of Lumbago During Menstruation at Cycle 13(Up to Cycle 13 (364 days) with 28 days per cycle)
- Distribution of Severity of Headache During Menstruation at Cycle 6(Up to Cycle 6 (168 days) with 28 days per cycle)
- Distribution of Severity of Headache During Menstruation at Cycle 13(Up to Cycle 13 (364 days) with 28 days per cycle)
- Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6(Up to Cycle 6 (168 days) with 28 days per cycle)
- Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13(Up to Cycle 13 (364 days) with 28 days per cycle)
- Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6(Up to Cycle 6 (168 days) with 28 days per cycle)
- Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13(Up to Cycle 13 (364 days) with 28 days per cycle)
- Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 6(From baseline up to Cycle 6 (168 days) with 28 days per cycle)
- Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 13(From baseline up to Cycle 13 (364 days) with 28 days per cycle)
- Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 6(From baseline up to Cycle 6 (168 days) with 28 days per cycle)
- Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 13(From baseline up to Cycle 13 (364 days) with 28 days per cycle)
- Number of Any Bleeding Episodes From Cycle 1 to Cycle 6(Up to Cycle 6 (168 days) with 28 days per cycle)
- Number of Any Bleeding Episodes From Cycle 1 to Cycle 13(Up to Cycle 13 (364 days) with 28 days per cycle)
- Number of Any Bleeding Days From Cycle 1 to Cycle 6(Up to Cycle 6 (168 days) with 28 days per cycle)
- Number of Any Bleeding Days From Cycle 1 to Cycle 13(Up to Cycle 13 (364 days) with 28 days per cycle)
- Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6(Up to Cycle 6 (168 days) with 28 days per cycle)
- Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13(Up to Cycle 13 (364 days) with 28 days per cycle)
- Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6(Up to Cycle 6 (168 days) with 28 days per cycle)
- Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13(Up to Cycle 13 (364 days) with 28 days per cycle)
- Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6(Up to Cycle 6 (168 days) with 28 days per cycle)
- Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13(Up to Cycle 13 (364 days) with 28 days per cycle)
- Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6(Up to Cycle 6 (168 days) with 28 days per cycle)
- Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13(Up to Cycle 13 (364 days) with 28 days per cycle)
- Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to Cycle 6(From baseline up to Cycle 6 (168 days) with 28 days per cycle)
- Change in Serum CA-125 From Baseline to Cycle 13(From baseline up to Cycle 13 (364 days) with 28 days per cycle)
- Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6(From baseline up to Cycle 6 (168 days) with 28 days per cycle)
- Change in Serum CRP From Baseline to Cycle 13(From baseline up to Cycle 13 (364 days) with 28 days per cycle)
研究者
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