CTRI/2023/06/053743已完成3 期
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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Female patients of age 18-45 years (both inclusive).
- •2. Patients diagnosed with endometriosis based on USG.
- •3. Patients with endometriosis associated pain score of at least 30mm on 100mm visual analog scale.
- •4. Patients willing to give written informed consent and comply with the study procedures.
排除标准
- •1. Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception.
- •2. Patients who have achieved menopause or have premature ovarian insufficiency.
- •3. Patients undergoing treatment for infertility by assisted reproductive technologies or any other procedure.
- •4. Patients with laparoscopic surgery for endometriosis within last 6 months.
- •5. 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.
- •6. Patients regularly using analgesics not intended to relieve endometriosis-related chronic pelvic pain (e.g. using analgesics for osteoarthritis etc).
- •7. Patients with any other significant concomitant gynecological disorder (fibroid etc).
- •8. 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.
- •9. Subjects with hepatic dysfunction (serum transaminases = 3 x Upper Normal Limit) or renal dysfunction (serum creatinine = 2.5 mg/dl).
- •10. 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.
- •11. Subjects with continuing history of alcohol and/or drug abuse.
- •12. Subjects with history of allergy to Dydrogesterone or other similar hormonal products.
- •13. Participation in another clinical trial in the past 3 months prior to screening.
- •14. Any other reason for which the investigator feels that patient should not participate.
研究者
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