CTRI/2024/06/068615尚未招募3 期
A Prospective, Randomized, Multi-Center, Parallel-Group, Assessor-Blind, Active-Controlled, Phase III Study to Assess the Efficacy and Safety of Fixed Dose Combination of Relugolix, Estradiol, and Norethindrone Acetate in Comparison to Leuprolide in Heavy Menstrual Bleeding Associated With Uterine Fibroids - REEMEMBER
Sun Pharmaceutical Industries Limited (SPIL)0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
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. Patient willing to provide written informed consent
- •2. Premenopausal female of age 18 – 50 years and BMI of 18 – 30 kg/m2
- •3. Regular menstrual periods of duration of 3 to 14 days and a cycle interval of 21 to 35 days (from the start of one menstrual period until the start of the next) for at least 3 months prior to Screening
- •4. Confirmed diagnosis of uterine fibroids that is supported by a documented evidence (either previous or at Screening) of ultrasound/CT abdomen/MRI abdomen and have not received any surgical treatment for uterine fibroid
- •5. Heavy menstrual bleeding associated with uterine fibroids
- •6. Women of childbearing potential must have a negative urine pregnancy test at Screening and at Randomization visit and not intend to become pregnant and agree to use 2 forms of non-hormonal contraceptive during the study
排除标准
- •1. Patients with ultrasound (at screening) demonstrating pathology other than uterine fibroids that could be responsible for or contributing to the patients heavy menstrual bleeding
- •2. Patient has a rapidly enlarging uterine fibroid as per Investigator’s opinion and who is planning to undergo gynaecological surgery or ablation procedures for uterine fibroids during the study period.
- •3. Patients with history or current osteoporosis or other metabolic bone disorder.
- •4. Patients with history or current clinically significant hypocalcaemia, hypo- or hyperphosphatemia
- •5. Patients with history of the use of bisphosphonates, calcitonin, calcitriol, teriparatide, denosumab, or any medication other than calcium and vitamin D preparations to treat BMD loss
- •6. Patients with history or current thyroid disorders
- •7. Patients with history (documented) of blood disorders
- •8. Patients with history of allergic or hypersensitive reaction or intolerance to any of the ingredients of relugolix or estradiol or norethindrone acetate or leuprolide or its excipients, that will be used in the study
- •9. Patients with history of lower abdominal pain due to irritable bowel syndrome or inflammatory bowel disease or severe intestinal cystitis or chronic UTI
- •10. Patients with history or current or suspected carcinoma breast or any other estrogen-dependent neoplasia
- •11. Patients with history of malignancy
- •12. Patients with history of bilateral oophorectomy or hysterectomy
- •13. Patients with marked intermenstrual bleeding as per Investigators opinion
- •14. Patients taking contraindicated medications within the last 12 weeks prior to Randomization
- •15. Patients with uncontrolled hypertension at Screening and Randomization or hypotension at Screening and Randomization
- •16. Patients with QTcF greater than or equal to 440 milliseconds in 12-lead ECG or any other abnormal ECG findings at Screening and Randomization
- •17. Patients with a Hb level less than 8.0 g/dL at Screening and Randomization
- •18. Patients with inadequate hepatic function (total bilirubin greater than or equal to 1.5 X ULN or AST greater than or equal to 3 X ULN or ALT greater than or equal to 3 X ULN)
- •19. Patients with a history of stroke, thrombotic event, thyroid disorder, convulsion, psychiatric disorder, cardiovascular disease, gastrointestinal, hepatic, renal, pulmonary, auto-immune disease, any active infection, or any other clinically significant condition requiring treatment which at the Investigator’s discretion might interfere with the study
- •20. Patients who has tested positive for HIV, HBV or HCV at Screening
- •21. Patient is pregnant or breastfeeding or planning a pregnancy within the next 6 months or less than 6 months postpartum, post-abortion, or post-pregnancy at the time of Screening
- •22. Patients with history of smoking within the last 3 months prior to Screening
- •23. Patients with history of alcohol or drug abuse within the last 3 months prior to Screening
- •24. Patients who have participated in another Investigational study within the 3 months prior to Screening in this study
- •25. Investigator, study personnel, sponsor representatives and their first-degree relatives
研究者
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