CTRI/2025/01/078944已完成3 期
A Prospective, Randomized, Multi-Centre, 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 leiomyomas (fibroids) in premenopausal women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 338
- 试验地点
- 25
- 主要终点
- less than 75 over the last 28 days
研究概览
简要总结
This is a prospective, randomized, multicenter, parallel-group, assessor-blind, active-controlled Phase III study. The study will commence following regulatory and Ethics Committee (EC) approval. After confirming eligibility, patients will be randomized in a 1:1 ratio into either the test or comparator arm. Patients in the test arm will receive a fixed-dose combination of Relugolix + Estradiol + NETA (40 mg + 1 mg + 0.5 mg) orally once daily for 12 weeks, while those in the comparator arm will be administered leuprolide depot injection intramuscularly every 4 weeks for 12 weeks. The randomized patients will continue their assigned treatment for 12 weeks, with Week 12 marking the End of Treatment (EOT) visit. Assessments will be conducted as per the Schedule of Assessments. The study includes a total of six visits. Patients will be provided with a diary and PBAC chart to record details on study product intake/administration, concomitant medications, menstrual bleeding, rescue medication, and any adverse events. Patients are required to bring their completed diaries to each visit. Safety and efficacy will be evaluated throughout the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Premenopausal female aged 18 to 50 years old inclusive on the day of signing and dating the informed consent form.
- •Patient with regularly occurring menstrual periods of 3 to 14 days duration with a cycle interval of 21 to 35 days from the start of 1 menstrual period until the start of the next, by participant history for at least 3 months prior to the first screening visit.
- •Confirmed diagnosis of uterine fibroids that is supported by documented evidence either previous or at Screening of transvaginal and or transabdominal ultrasound or CT abdomen or MRI abdomen and have not received any surgical treatment for uterine fibroid and at least one measurable non-calcified myoma with a longest diameter of less than or equal to 3 cm at Screening visit.
- •Patient with heavy menstrual bleeding associated with uterine fibroids as evidenced by a PBAC score more than or equal to 100 which corresponds to MBL more than 80 mL in the previous menstrual cycle at Randomization visit
- •Women of childbearing potential WOCBP must be using an acceptable method of contraception to avoid pregnancy throughout the study.
- •WOCBP must have a negative urine pregnancy test at screening or baseline visit.
- •Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
- •Minimum Education 8th pass.
- •Patients willing to comply with the protocol requirements.
排除标准
- •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.
- •Patients with history or current osteoporosis or other metabolic bone disorder.
- •Patients with history or current clinically significant hypocalcaemia, hypo- or hyperphosphatemia
- •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
- •Patients with history or current thyroid disorders
- •Patients with history (documented) of blood disorders
- •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
- •Patients with history of lower abdominal pain due to irritable bowel syndrome or inflammatory bowel disease or severe intestinal cystitis or chronic UTI
- •Patients with history or current or suspected carcinoma breast or any other estrogen-dependent neoplasia
- •Patients with history of malignancy
- •Patients with history of bilateral oophorectomy or hysterectomy
- •Patients with marked intermenstrual bleeding as per Investigators opinion
- •Patients taking contraindicated medications within the last 12 weeks prior to Randomization
- •Patients with uncontrolled hypertension at Screening and Randomization or hypotension at Screening and Randomization
- •Patients with QTcF greater than or equal to 440 milliseconds in 12-lead ECG or any other abnormal ECG findings at Screening and Randomization
- •Patients with a Hb level less than 8.0 g/dL at Screening and Randomization
- •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)
- •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
- •Patients who has tested positive for HIV, HBV or HCV at Screening
- •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
- •Patients with history of smoking within the last 3 months prior to Screening
- •Patients with history of alcohol or drug abuse within the last 3 months prior to Screening
- •Investigator, study personnel, sponsor representatives and their first-degree relatives.
结局指标
主要结局
less than 75 over the last 28 days
时间窗: Percentage of patients to achieve PBAC score | less than 75 over the last 28 days
Percentage of patients to achieve PBAC score
时间窗: Percentage of patients to achieve PBAC score | less than 75 over the last 28 days
次要结局
- Percentage of patients to achieve a 50 percent reduction of PBAC score(Baseline to Week 12)
- Percentage of patients to achieve amenorrhea(Baseline to Week 12)
- Time to achieve amenorrhea(Baseline to Week 12)
- Percentage change from baseline in PBAC score over the last 28 days(Baseline to Week 12)
- Percentage change from baseline in primary uterine fibroid volume(Baseline to Week 12)
研究者
Dr Avinash Andhale
Vivotech Research Private Limited
研究点 (25)
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