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
Sun Pharmaceutical Industries Limited (SPIL)27 个研究点 分布在 1 个国家目标入组 338 人开始时间: 2024年6月18日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 338
- 试验地点
- 27
- 主要终点
- Percentage of patients to achieve PBAC score less than 75 over the last 28 days
研究概览
简要总结
This is a prospective, randomized, multi-center, parallel-group, assessor-blind, active-controlled, phase III study. The study will be initiated only after the receipt of regulatory and EC approval.
After confirming the eligibility, patients will be randomized in 1:1 ratio in either test arm or comparator arm. Patients in test arm will receive FDC of Relugolix + Estradiol + NETA (40 mg + 1 mg + 0.5 mg) once daily orally for 12 weeks, while patients in comparator arm will be administered leuprolide depot injection intramuscularly once every 4 weeks till 12 weeks. The randomized patients will take the allotted study medication for 12 weeks (Treatment period) and Week 12 will be considered EOT visit. During the study, assessments will be performed as mentioned in Schedule of Assessment.
The study consists of total six visits. Patients will be provided with diary and PBAC chart to record details about study product intake/administration, concomitant medication, menstrual bleeding details, any rescue medication taken, and adverse events. Patients will be required to bring completed diary at each visit. The safety and efficacy will be assessed during 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
- •Patient willing to provide written informed consent
- •Premenopausal female of age 18 – 50 years and BMI of 18 – 30 kg/m2
- •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
- •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
- •Heavy menstrual bleeding associated with uterine fibroids
- •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
- •Patients with ultrasound (at screening) demonstrating pathology other than uterine fibroids that could be responsible for or contributing to the patients heavy menstrual bleeding
- •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
Percentage of patients to achieve PBAC score less than 75 over the last 28 days
时间窗: Baseline to 12 weeks
次要结局
- Percentage of patients experiencing vasomotor symptoms(up to 12 weeks)
- Percentage of patients to achieve a 50 percentage reduction of PBAC score from Baseline(Baseline, 12 weeks)
- Percentage change from baseline in primary uterine fibroid volume(Baseline, 12 weeks)
- Proportion of patients with AEs(Screening to Week 16)
研究者
Dr Pravin Ghadge
Sun Pharma Laboratories Limited
研究点 (27)
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