A prospective, randomized, double-blind, single-dummy, two-arm, active-controlled, parallel, multicentre, phase III clinical trial to assess the efficacy & safety of Dydrogesterone Extended Release Tablets 30mg as compared to Dydrogesterone Tablets 10mg for treatment of endometriosis in women.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 10
- 主要终点
- Change in Endometriosis Associated Pelvic Pain (EAPP) from baseline to end of study as assessed on 100mm VAS scale.
研究概览
简要总结
This will be aprospective, randomized, double-blind, single-dummy parallel, active controlled,multicenter, non-inferiority, phase III clinical trial to assess the efficacyand safety of Dydrogesterone Extended Release Tablets 30 mg as compared to DydrogesteroneTablets 10 mg for treatment of endometriosis in women. The test drug isindicated for once daily dosing while the reference drug is indicated forthrice daily dosing. Due to this difference in dosing of the test and thereference drugs, a similar looking placebo will be used for the patientsenrolled in the test group to maintain double blinding. All the drugs i.e., thetest drug, the reference drug or the placebo will have identical physicalcharacteristics and will be indistinguishable from each other. Randomizationwill prevent the selection / treatment allocation bias and double blinding willprevent the bias in the assessment of treatment effects. Randomized patients willbe enrolled in either of the 2 study groups as per their randomization numberand will be followed up in a parallel manner till the completion of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients of age 18-45 years (both inclusive).
- •Patients diagnosed with endometriosis based on USG.
- •Patients with endometriosis associated pain score of at least 30mm on 100mm visual analog scale.
- •Patients willing to give written informed consent and comply with the study procedures.
排除标准
- •Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception.
- •Patients who have achieved menopause or have premature ovarian insufficiency.
- •Patients undergoing treatment for infertility by assisted reproductive technologies or any other procedure.
- •Patients with laparoscopic surgery for endometriosis within last 6 months.
- •Patients who have taken hormone therapy (danazol, progestins or other sex hormones, corticosteroids, GnRH analogs or gestrinone) in last 6 months or oral contraceptives in last 3 months.
- •Patients regularly using analgesics not intended to relieve endometriosis-related chronic pelvic pain (e.g. using analgesics for osteoarthritis etc).
- •Patients with any other significant concomitant gynecological disorder (fibroid etc).
- •Subjects with active or recent (within 6 months) arterial thromboembolic disease (e.g. angina, myocardial infarction) or venous thromboembolism (deep vein thrombosis, pulmonary embolism) or at high risk of venous or arterial thrombosis.
- •Subjects with hepatic dysfunction (serum transaminases ≥ 3 x Upper Normal Limit) or renal dysfunction (serum creatinine ≥ 2.5 mg/dl).
- •Subjects with any other clinically significant uncontrolled systemic diseases such as gastrointestinal, respiratory, cardiovascular, renal, neurological, psychiatric, endocrine (diabetes), immunological or hematological disorders or malignancy.
- •Subjects with continuing history of alcohol and/or drug abuse.
- •Subjects with history of allergy to Dydrogesterone or other similar hormonal products.
- •Participation in another clinical trial in the past 3 months prior to screening.
结局指标
主要结局
Change in Endometriosis Associated Pelvic Pain (EAPP) from baseline to end of study as assessed on 100mm VAS scale.
时间窗: At Baseline / Visit 2 (Day 0), | At Visit 3 (Day 30), | At Visit 4 (Day 60) and | At Visit 5 (Day 90).
次要结局
- Consumption of rescue pain medication for endometriosis associated pelvic pain during the study period in the two groups.(At Visit 3 (Day 30),)
- Change in size of Endometrioma from baseline to end of study as assessed(by USG.)
- Change in serum VEGF levels from baseline to the end of the study in the two groups.(At Baseline / Visit 2 (Day 0) and)
- Changes from baseline in the health-related quality of life using the HRQoL-4 questionnaire in the two groups at the end of the study.(At Baseline / Visit 2 (Day 0),)
- Adverse events / serious adverse events reported during the study.(At Baseline / Visit 2 (Day 0),)