CTRI/2020/10/028464已完成3 期
A Phase III, Prospective, Randomized, Double Blind, Single Dummy, Active Controlled, Comparative, Parallel Group, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Medroxyprogesterone Acetate SR Tablets 30 mg Versus Medroxyprogesterone Acetate Tablets 10 mg for the treatment of Endometriosis in women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 186
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 aged between 18-45 years (both inclusive).
- •2. Patients diagnosed with endometriosis associated with pain based on imaging studies i.e., USG.
- •3. Patients with endometriosis associated with pain having a score of at least 30 mm on a 100 mm visual analog scale.
- •4. Patients having agreed to the use of double barrier contraception (use of the male condom along with either diaphragm, cervical cap, or copper T IUD).
- •5. Patients with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
- •6. Patients willing to comply with the protocol requirements.
排除标准
- •1. Patients who are hypersensitive to Medroxyprogesterone Acetate or any of its components.
- •2. Patients with laparoscopic surgery for endometriosis within 6 months before enrollment / screening.
- •3. Has clinical laboratory evaluations (including biochemistry and hematology) are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator.
- •4. Female patients who are pregnant or lactating or planning to become pregnant during the study period.
- •5. Females who are not ready to use acceptable contraceptive methods during the course of study.
- •6. Women suffering from infertility issues.
- •7. Presence of Chocolate Cyst in the ovary greater than 3 cm in diameter.
- •8. Patients with history of blood clots related disease: Deep vein thrombosis, pulmonary embolism and stroke.
- •9. Before menarche or after menopause.
- •10. Amenorrhea (more than three consecutive months before screening).
- •11. Patients with previous use of hormonal agents (e.g. GnRH agonists <= 6 months, Danazol <= 3 months or oral contraceptives <= 1 month before screening).
- •12. Patients with abnormal uterine bleeding.
- •13. Patients with known case of clinically significant cerebrovascular disease, cardiovascular disease, thyroid dysfunction, chronic uncontrolled systemic diseases like asthma, hypertension, collagen disorders, severe infections, that may affect patient safety.
- •14. Patients with any abnormality detected on ECG at the time of screening.
- •15. Patients with known case of type 1 diabetes and type 2 diabetes mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value greater than 8%.
- •16. Patients with clinically significant impaired hepatic function. [SGOT & SGPT more than 3X the UNL and/or Total bilirubin more than 1.5X the UNL].
- •17. Patients with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2.
- •18. Patients with dyslipidemia.
- •19. Patients with history of wasting disease, autoimmune disease, connective tissue disease, osteoporosis or use of anticonvulsants or corticosteroids.
- •20. Patients with history of drug or alcohol abuse within the previous 2 years.
- •21. Patients with medical history of oncological conditions since last 5 years.
- •22. Patients with known case of HIV, Hepatitis B & C.
- •23. Concurrent participation in another clinical trial within 90 days prior to signing informed consent.
- •24. Currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
- •25. Suspected inability or unwillingness to comply with the study procedures.
- •26. Patients with clinically significant disorder that, in the opinion of the investigator, would result in jeopardizing patientâ??s safety and efficacy of the drug.
研究者
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