EUCTR2018-001368-43-IT进行中（未招募）1 期
An International Phase 3 Double-Blind, Placebo-controlled, Randomized Withdrawal Study of Relugolix Co-administered with Estradiol and Norethindrone Acetate in Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids - NA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •A woman will be eligible for enrollment in this study only if all of the
- •following inclusion criteria are met at the time of the Week 52/Baseline visit:
- •1. Completed the OLE study;
- •2. Has voluntarily signed and dated the informed consent form prior to initiation of any screening or study-specific procedures for MVT-601-
- •035; Note: Procedures conducted as part of the OLE study that also serve as baseline procedures for this study may be done under the informed consent for the OLE study;
- •3. Is not expected to undergo gynecological surgery or ablation procedures for uterine fibroids within the study period, including the Safety Follow-up period;
- •4. Is a responder: Has a menstrual blood loss of < 80 mL AND at least a 50% reduction from the Parent study baseline based on the results of the alkaline hematin testing performed on the feminine products returned at the Week 48 visit of the OLE study. Results from Week 44 may be used if Week 48 data is unavailable;
- •5. Has a negative urine pregnancy test at the Week 52/Baseline visit;
- •6. Agrees to continue to use acceptable nonhormonal contraceptive methods as described in protocol consistently during the treatment period and for at least 30 days after the last dose of study drug. However, the patient is not required to use the specified non hormonal contraceptive methods if she:
- •a. Has a sexual partner(s) who was vasectomized at least 24 weeks prior to the Week 52/Baseline visit;
- •b. Had a bilateral tubal occlusion (including ligation and blockage methods such as Essure™), at least 16 weeks prior to the Week 52/Baseline visit (patients with Essure must have prior confirmation of tubal occlusion by hysterosalpingogram) and there must be no evidence of post-Essure syndrome;
- •c. Has a nonhormonal intrauterine device (e.g., Paragard®) placed in the uterus;
- •d. Is not sexually active with men; periodic sexual relationship(s) with men requires the use of nonhormonal contraception as noted above;
- •e. Practices total abstinence from sexual intercourse, as her preferred lifestyle; periodic abstinence is not acceptable
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 250
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •None of the following criteria may be true for a patient to be eligible for enrollment into this study:
- •1.Has undergone myomectomy, ultrasound-guided laparoscopic radiofrequency ablation, or any other surgical procedure for fibroids, uterine artery embolization, magnetic resonance-guided focused ultrasound for fibroids, or endometrial ablation for abnormal uterine bleeding at any time during the Parent study or OLE study;
- •2.Has a weight that exceeds the weight limit of the DXA scanner or has a condition that precludes an adequate DXA measurement at the lumbar spine and proximal femur (e.g., bilateral hip replacement or spinal hardware in the lumbar spine);
- •3.Anticipates use of any prohibited medications as detailed in Section 5.9.1;
- •4.Has developed any contraindication to treatment with estradiol or norethindrone acetate including:
- •a.Known or suspected breast cancer;
- •b.Known or suspected estrogen-dependent neoplasia;
- •c.Active deep vein thrombosis or pulmonary embolism;
- •d.Active arterial thromboembolic disease, including stroke and myocardial infarction;
- •e.Known anaphylactic reaction or angioedema or hypersensitivity to estradiol or norethindrone acetate;
- •f.Known protein C, protein S, or antithrombin deficiency, or other known thrombophilia disorders, including Factor V Leiden;
- •g.Migraine with aura;
- •h.Porphyria;
- •5.Has current active liver disease from any cause;
- •6.Has a new diagnosis of a systemic autoimmune disease (e.g., systemic lupus erythematosus, Sjogren’s syndrome, rheumatoid arthritis, polymyositis, systemic sclerosis, psoriasis, psoriatic arthritis, vasculitic syndromes, etc.). Psoriasis not requiring or anticipated to require systemic therapy is permitted;
- •7.Had any of the following clinical laboratory abnormalities at the OLE study Week 48 visit or any subsequent visit:
- •a.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.0 times the upper limit of normal (ULN); or
- •b.Bilirubin (total bilirubin) > 1.5 x ULN (or > 2.0 x ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome);
- •c.Hemoglobin < 8 g/dL despite iron supplementation;
- •8.Is currently pregnant or lactating, or intends to become pregnant during the study period or within 4 weeks after the last dose of study drug, or plans to donate ova during the study period or within 8 weeks after the last dose of study drug;
- •9.Is inappropriate for participation in this study because of conditions that may interfere with interpretation of study results or prevent the patient from complying with study requirements, as determined by the investigator, sub-investigator, or medical monitor;
- •10.Met a withdrawal criterion in the OLE study
研究者
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