A Prospective, Randomized, Single-blind, Single-dummy, Two-arm, Multicentric Study To Assess the Efficacy And Safety Of Dydrogesterone Modified Release Tablets 20 mg OD Compared to Dydrogesterone 10 mg IR (BID) in the Management Of Endometriosis - Nil

Ms Abbott India Limited0 个研究点目标入组 230 人开始时间: 待定最近更新: 2024年6月24日

试验速览

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•1. Women of the age group 18 to 45 years (both ages inclusive).
•2. Subjects with endometriosis and chronic pelvic pain, with or without dysmenorrhea, including subjects with post-surgical recurrence of endometriosis after 6 months of surgery
•2.1. chronic pelvic pain assessed by a score of 30 mm on a 100 mm visual analog scale (VAS)
•2.2. clinically and ultrasound diagnosed endometriosis3. Willing to give written informed consent and comply with the study procedures

•1. Any concomitant severe disease or genital disorder or any other condition requiring continuous medical treatment
•2. Regular use of analgesics not intended to relieve endometriosis-related chronic pelvic pain.
•3. Pregnancy or lactating women or lactating within 3 months of enrollment
•4. Not ready to use acceptable contraceptive methods during study
•5. Menopause or premature ovarian insufficiency
•6. Contraindications to treatment with Dydrogesterone
•7. Intake of any experimental drug or participated in another trial in the past 30 days prior to screening
•8. Hepatic dysfunction (Serum transaminase=3 × Upeer normal limit) or renal dysfunction (Serum creatinine =2.5 mg/dL)
•9. Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurologic/psychiatric, allergy, recent major surgery ( < 3 months), or other relevant diseases as revealed by history, physical examination and/or laboratory assessments
•which could limit participation in or completion of the study
•10. Known allergic reactions to progesterone products
•11. Continuing history of alcohol and/or drug abuse

发起方

Ms Abbott India Limited