A Post-Marketing, Prospective, Multicenter, Observational Program: Treatment Regimen in Menstrual Cycle Regularization and Persistence in Routine Clinical Practice in Russia, Ukraine, Kazakhstan and Uzbekistan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 999
- 试验地点
- 66
- 主要终点
- Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number)
研究概览
简要总结
Dydrogesterone is approved in more than 100 countries including Russia, Ukraine, Kazakhstan and Uzbekistan and widely used for the treatment of progesterone deficiencies such as for management of dysmenorrhea, endometriosis, secondary amenorrhea, irregular cycles, dysfunctional uterine bleeding, pre-menstrual syndrome, threatened and habitual miscarriage, infertility due to luteal insufficiency, as well as part of hormone replacement therapy. There are limited data regarding dydrogesterone's role in achieving cycle regularization from post-marketing settings. There is need to assess the persistence of dydrogesterone therapy in a post-marketing setting after cessation of treatment and whether the persistence, if any, is related to the duration of dydrogesterone therapy. Hence, in this observational program, the goal is to observe the possible implications of such treatment in terms of treatment length and response pattern.
详细描述
The program is designed as a prospective, multicentre, observational, non-interventional, non-randomized, non-controlled, single arm, post-marketing program. Being an observational program, the assignment of patients to dydrogesterone therapy will not be decided with an intention to include patients in the program, but will be guided as per standard clinical practice of the treating physician. Hence the prescribing of dydrogesterone will be clearly separate from the decision to include patients in this program. All dydrogesterone prescriptions will be made in accordance with locally approved package insert for dydrogesterone.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number)
时间窗: up to 6 months
Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles)
时间窗: up to 6 months
次要结局
- Proportion of Patients Reporting at Least One Regular Cycle Over the Treatment Period(Up to 6 months)
- Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Polymenorrhea(From 1 month to 6 months)
- Proportion of Patients With 6 Consecutive Regular Cycles Out of Total Number of Patients Who Had Achieved Cycle Regularization at the End of Treatment Period(Up to 12 months)
- Proportion of Patients With 3 Consecutive Regular Cycles Out of Total Number of Patients Who Had Achieved Cycle Regularization at the End of Treatment Period(Up to 9 months)
- Change of Pain Intensity During Menstruation(From 1 month to 12 months)
- Change of Pain Intensity During Menstruation From Baseline to End of Treatment(From 1 month to 6 months)
- Change of Intensity of Anxiety(From 1 month to 12 months)
- Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Oligomenorrhea(From 1 month to 6 months)
- Change of Duration of Menstrual Bleeding in Group of Patients With Polymenorrhea(From 1 month to 6 months)
- Change of Intensity of Anxiety From Baseline to the End of Treatment(From 1 month to 6 months)
- Patient Satisfaction With the Treatment(Up to 6 months)
- Change of Duration of Menstrual Bleeding in Days in Group of Patients With Polymenorrhea(From 1 month to 12 months)
- Change of Duration of Menstrual Bleeding in Days in Group of Patients With Oligomenorrhea(From 1 month to 12 months)
- Change of Duration of Menstrual Bleeding in Group of Patients With Oligomenorrhea(From 1 month to 6 months)
- Overall Clinical Response on Treatment Assessed by Physician(Up to 6 months)
- Time to Relapse(Up to 6 months or longer after ended treatment)