Observational Open-Label Multicenter Study of Real Clinical Practice to Evaluate the Effects of Hormonal Therapy With Oral Dydrogesterone for Treatment of Confirmed Endometriosis (ORCHIDEA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 350
- 试验地点
- 20
- 主要终点
- Change in chronic pelvic pain intensity
研究概览
简要总结
A non-interventional, observational program to assess the effects of dydrogesterone (Duphaston®) 6-months-administration in patients with confirmed endometriosis in a post-marketing setting in the Russian Federation
详细描述
A non-interventional, observational program to assess the effects of oral dydrogesterone therapy in a post-marketing setting whether the effects are related to the regimen of dydrogesterone therapy. In this observational program, assuming that dydrogesterone plays a role in the treatment of endometriosis without suppression of ovulation, the goal is to observe the possible implications of such treatment in terms of treatment regimen and response pattern. In the study will be described effects of Duphaston® 6-months-administration in patients with confirmed endometriosis by assessing pain relief, quality of life, need of self-medication with analgesics, etc.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, aged ≥ 18 years and ≤ 45 years.
- •Complaints on chronic pelvic pain with or without dysmenorrhea assessed by 11-items NRS.
- •External genital endometriosis confirmed by laparoscopy.
- •Existing pelvic (vaginal) ultrasound data not earlier than 2 months before inclusion in the study.
- •Prescribed treatment with Duphaston® according local labelling for treatment of endometriosis 10 mg 2-3 times a day from the 5th to the 25th day of the menstrual period cycle or continuously.
- •No hormonal treatment in 2 cycles before enrollment.
- •Signed Patient Authorization for Use/Disclosure of Data.
排除标准
- •Any co-existing disease(s) needing chronic drug therapy (e.g. Crohn's disease, diabetes etc); Severe concomitant medical illness.
- •Severe other genital pathology excluding endometriosis (e.g. Multiple/severe myoma; adenomyosis, inflammatory diseases, etc.).
- •Routine consumption of analgesics other than for the pain of endometriosis.
- •Patients receiving hormonal contraceptives in last 2 cycles (including intrauterine devices, contraceptive patches, contraceptive rings, oral contraceptives etc.).
- •Ongoing pregnancy.
- •Menopause or premature ovarian failure.
- •Contraindications to dydrogesterone treatment listed in the locally approved label (Instructions for the medical use of Duphaston®).
- •Any other condition that precludes use of dydrogesterone in a particular patient, in accordance with the precautions and special warnings listed in the locally approved label (Instructions for the medical use of Duphaston®).
- •Abnormal results of pap smear test.
- •Other conditions that made the patients participation impossible (based on the investigator decision).
- •Fertility treatments using assisted reproductive technology.
研究组 & 干预措施
Endometriosis/Dydrogesterone
Females aged 18 to 45 years, suffering external genital endometriosis confirmed by laparoscopy, for whom were prescribed treatment with Duphaston®
干预措施: Duphaston® (Dydrogesterone) (Drug)
结局指标
主要结局
Change in chronic pelvic pain intensity
时间窗: 6 months
The changes in chronic pelvic pain intensity assessed by 11-items Numerous Rating Scale (NRS) at the end of observation (Visit 3) versus Baseline (Visit 1) in the prolonged cyclic regime and the continuous regime of Duphaston in patients with endometriosis. The 11-items Numerous Rating Scale (NRS) contains the range from 0 to 10, where 0 represents 'no pain' and 10 represents 'the worst pain'. Patients are asked to point the average pain intensity throughout the last month. The negative change corresponds to better result.
次要结局
- Sexual wellbeing(6 months)
- Cycles' duration(6 months)
- Analgesics using(6 months)
- Change in chronic pelvic pain intensity(3 months, 6 months)
- Change in Quality of Life(3 months, 6 months)
- Change in dysmenorrhea(3 months, 6 months)