NCT00909857已完成3 期
A Multi-center, Double-blind, Double-dummy, Randomized, Controlled, Parallel-group Study to Assess Efficacy and Safety of SH T00658ID Compared to SH D593B in the Treatment of Primary Dysmenorrhea
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 507
- 主要终点
- Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain
研究概览
简要总结
To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 14 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Otherwise healthy female subjects requesting contraception and suffering from primary dysmenorrhea with a sum score for dysmenorrheic pain intensity of >/= 8 over 2 baseline cycles documented by a prospective self-rated sum pain score
- •Age: 14 - 50 years (inclusive; smokers must not be older than 30 years) at the time point of informed consent
- •Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at the screening visit, or a normal result has to be available that was documented within the last 6 months before the screening visit)
- •Women with cyclic menstrual bleeding, defined by a cycle length between 25 and 35 days and no amenorrheic cycles or cycles without withdrawal bleeding during the last 3 months prior to visit
- •Able to tolerate ibuprofen and willing to use only Ibuprofen supplied for the study.
排除标准
- •Pregnancy or lactation (delivery, abortion, or lactation within three cycles before the start of treatment)
- •Obesity: body mass index (BMI) > 32 kg/m2
- •Hypersensitivity to any of the study drug ingredients
- •Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
- •Presence or a history of venous or arterial thrombotic / thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (e.g. transient ischemic attack, angina pectoris), and conditions that could increase the risk of suffering from any of the above mentioned disorders, e.g. a family history indicating a hereditary predispositionUndiagnosed abnormal genital bleeding
- •Abuse of alcohol, drugs, or medicines (e.g. laxatives)
- •Other contraceptive methods:
- •Sterilization
- •Oral, vaginal or transdermal hormonal contraception during treatment
- •Intra-uterine devices (IUD) with or without hormone release still in place within 30 days of visit 1
- •Simultaneous participation in another clinical trial or participation in another clinical trial prior to study entry that might have an impact on the study objectives at the discretion of the investigator
- •Major surgery scheduled for the study period
研究组 & 干预措施
Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
Experimental
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
干预措施: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) (Drug)
Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
Experimental
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
干预措施: Placebo Match to SH T00658ID (Drug)
Ethinyl estradiol, Levonorgestrel (Miranova)
Active Comparator
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
干预措施: Ethinyl estradiol, Levonorgestrel (Miranova) (Drug)
Ethinyl estradiol, Levonorgestrel (Miranova)
Active Comparator
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
干预措施: Placebo Match to SH D593B (Drug)
结局指标
主要结局
Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain
时间窗: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Dysmenorrheic pain was defined as pelvic pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
次要结局
- Number of Episodes With Bleeding or Spotting(From day 1 to day 90)
- Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain(baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days))
- Number of Episodes With Spotting-only(From day 1 to day 90)
- Mean Length of Spotting Only Episodes(From day 1 to day 90)
- Maximum Length of Spotting Only Episodes(From day 1 to day 90)
- Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding(baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days))
- Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding(baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days))
- Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode)(baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days))
- Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used)(baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days))
- Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before)(baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days))
- Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used)(baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days))
- Percentage of Participants Satisfied With Study Treatment(From cycle 1 to cycle 3 (28 days per cycle))
- Percentage of Participants With Withdrawal Bleeding at Cycle 3(At cycle 3 (28 days per cycle))
- Mean Length of Bleeding or Spotting Episodes(From day 1 to day 90)
- Maximum Length of Bleeding or Spotting Episodes(From day 1 to day 90)
- Onset of Withdrawal Bleeding Episodes at Cycle 3(At cycle 3 (28 days per cycle))
- Participants With Improvement in Participants' Assessment in the Clinical Global Impression(At cycle 2 (28 days per cycle))
- Number of Days With Bleeding or Spotting(From day 1 to day 90)
- Number of Days With Spotting-only(From day 1 to day 90)
- Length of Withdrawal Bleeding Episodes at Cycle 1(At cycle 1 (28 days per cycle))
- Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3(At cycle 3 (28 days per cycle))
- Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3(At cycle 3 (28 days per cycle))
- Difference in Duration Between Longest and Shortest Bleeding or Spotting Episode(From day 1 to day 90)
- Difference in Duration Between Longest and Shortest Spotting Only Episode(From day 1 to day 90)
- Percentage of Participants With Withdrawal Bleeding at Cycle 1(At cycle 1 (28 days per cycle))
- Number of Intracyclic Bleeding Episodes at Cycle 3(At cycle 3 (28 days per cycle))
- Maximum Length of Intracyclic Bleeding Episodes at Cycle 1(At cycle 1 (28 days per cycle))
- Maximum Length of Intracyclic Bleeding Episodes at Cycle 3(At cycle 3 (28 days per cycle))
- Length of Withdrawal Bleeding Episodes at Cycle 3(At cycle 3 (28 days per cycle))
- Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1(At cycle 1 (28 days per cycle))
- Onset of Withdrawal Bleeding Episodes at Cycle 1(At cycle 1 (28 days per cycle))
- Percentage of Participants With Intracyclic Bleeding at Cycle 1(At cycle 1 (28 days per cycle))
- Percentage of Participants With Intracyclic Bleeding at Cycle 3(At cycle 3 (28 days per cycle))
- Number of Intracyclic Bleeding Episodes at Cycle 1(At cycle 1 (28 days per cycle))
- Number of Intracyclic Bleeding Days at Cycle 1(At cycle 1 (28 days per cycle))
- Number of Intracyclic Bleeding Days at Cycle 3(At cycle 3 (28 days per cycle))
- Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1(At cycle 1 (28 days per cycle))
- Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening(At screening (28 days))
- Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle(At Baseline (28 days per cycle))
- Own Costs of Physiotherapy Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire(At screening (average over 3 months before screening))
- Own Costs of Pain Medication Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire(At screening (average over 3 months before screening))
- Own Costs of Vitamins Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire(At screening (average over 3 months before screening))
- Own Costs of Massages Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire(At screening (average over 3 months before screening))
- Own Costs of Acupuncture Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire(At screening (average over 3 months before screening))
- Own Costs of Medical Counseling Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire(At screening (average over 3 months before screening))
- Own Costs of Alternative Medicine Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire(At screening (average over 3 months before screening))
- Own Costs of Herbs/Teas Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire(At screening (average over 3 months before screening))
- Other Own Costs Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire(At screening (average over 3 months before screening))
- Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle(At baseline cycle (28 days per cycle))
- Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2(At cycle 2 (28 days per cycle))
- Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination(At final examination (28 days))
- Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression(At cycle 2 (28 days per cycle))
- Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle(At baseline cycle (28 days per cycle))
- Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination(at final examination (28 days))
- Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination(At final examination (28 days))
- Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle(At baseline cycle (28 days per cycle))
- Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination(At final examination (28 days))
- Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle(At baseline cycle (28 days per cycle))
- Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination(At final examination (28 days))
- General Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination(At final examination (28 days))
- Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle(At baseline cycle (28 days per cycle))
- Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle(At baseline cycle (28 days per cycle))
- Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination(At final examination (28 days))
- General Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle(At baseline cycle (28 days per cycle))
- Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle(At baseline cycle (28 days per cycle))
- Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination(At final examination (28 days))
- Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination(At final examination (28 days))
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