EUCTR2017-003310-74-IT进行中（未招募）1 期
IBERTY EXTENSION: An International Phase 3 Open-Label, Single-Arm, Long-Term Efficacy and Safety Extension Study to Evaluate Relugolix Co-Administered with Low-Dose Estradiol and Norethindrone Acetate in Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids - A study to evaluate the long term Efficacy and Safety of Relugolix in Women With Heavy Menstrual Ble
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
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
- •1.Completed 24 weeks of study drug treatment and study participation in either MVT-601-3001 orMVT-601-3002;
- •2.Has voluntarily signed and dated the informed consent form prior to initiation of any screening or study-specific procedures for MVT-601-3003;
- •3.Is not expected to undergo gynecological surgery or ablation procedures for uterine fibroids withinthe study period, including during the Safety Follow-Up period;
- •4.Has a negative urine pregnancy test at the Week 24/Baseline visit;
- •5.Agrees to continue to use acceptable nonhormonal contraceptive methods as described in Section 4.6 consistently during the Open-Label 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 nonhormonalcontraceptive methods if she:
- •a.Has a sexual partner(s) who was vasectomized at least 6 months prior to the Week 24/Baseline visit;
- •b.Had a bilateral tubal occlusion (including ligation and blockage methods such as Essure™), at least 4 months prior to the Week 24/Baseline visit (patients with Essure must have prior confirmation of tubal occlusion by hysterosalpingogram) and there must be no evidence ofpost-Essure syndrome;
- •c.Has a nonhormonal intrauterine device (eg, 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 600
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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 (MVT-601-3001 or MVT-601-3002);
- •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 (eg, bilateral hip replacement, spinal hardware in the lumbar spine);
- •3.Has a Z-score < -2.0 or has a = 7% decrease in bone mineral density from the parent study Baseline at lumbar spine, total hip, or femoral neck based on the parent study Week 24 DXA assessment of bone mineral density;
- •4.Anticipated to use any prohibited medications as detailed in Section 5.9.1;
- •5.Has any contraindication to treatment with low-dose estradiol and norethindrone acetate, including:
- •a.Known, suspected, or history of breast cancer;
- •b.Known or suspected estrogen-dependent neoplasia;
- •c.Active deep vein thrombosis or pulmonary embolism, or history of these conditions prior to the Week 24/Baseline visit;
- •d.History of or active arterial thromboembolic disease, including stroke and myocardial infarction;
- •e.Known anaphylactic reaction or angioedema or hypersensitivity to estradiol or norethindroneacetate;
- •f.Known protein C, protein S, or antithrombin deficiency, or other known thrombophiliadisorders, including Factor V Leiden;
- •g.Migraine with aura;
- •h.History of porphyria;
- •6.Has current active liver disease from any cause;
- •7.Has a systemic autoimmune disease (eg, 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;
- •8.Had any of the following clinical laboratory abnormalities at the parent study Week 20 visit or any subsequent visit in one of the parent studies (MVT-601-3001 or MVT-601-3002):
- •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);
- •9.Is currently pregnant or lactating, or intends to become pregnant during the study period or within1 month after the last dose of study drug, or plans to donate ova during the study period or within2 months after the last dose of study drug;
- •10.Has a decline in presenting visual acuity score as defined below (unless explained by refractive error or approved by the Sponsor):
- •a.90 or lower and 5 or more points lower at Week 24/Baseline visit relative to the parent study Baseline visit; OR
- •b.The presenting visual acuity score has decreased by 10 or more points at the Week 24/Baseline visit relative to the parent study Baseline visit;
- •Note: visual acuity score must have been obtained with corrective lenses, if applicable;
- •11. 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.
- •12. Met a withdrawal criterion in the parent study (MVT-601-3001 or MVT-601-3002).
研究者
相似试验
进行中（未招募）
1 期
A study to evaluate the long term Efficacy and Safety of Relugolix in Women With Heavy Menstrual Bleeding Associated with Uterine FibroidsEUCTR2017-003310-74-PLMyovant Sciences GmbH600
进行中（未招募）
1 期
A study to evaluate the long term Efficacy and Safety of Relugolix in Women With Heavy Menstrual Bleeding Associated with Uterine Fibroidsheavy menstrual bleeding associated with uterine fibroidsMedDRA version: 20.0Level: LLTClassification code 10027331Term: Menstrual flow alteredSystem Organ Class: 100000004872MedDRA version: 21.1Level: LLTClassification code 10046783Term: Uterine fibroidSystem Organ Class: 100000004864EUCTR2017-003310-74-BEMyovant Sciences GmbH600
进行中（未招募）
1 期
A study to evaluate the long term Efficacy and Safety of Relugolix in Women With Heavy Menstrual Bleeding Associated with Uterine Fibroidsheavy menstrual bleeding associated with uterine fibroidsMedDRA version: 20.0Level: LLTClassification code 10027331Term: Menstrual flow alteredSystem Organ Class: 100000004872MedDRA version: 21.1Level: LLTClassification code 10046783Term: Uterine fibroidSystem Organ Class: 100000004864EUCTR2017-003310-74-HUMyovant Sciences GmbH600
进行中（未招募）
1 期
A study to evaluate the long term Efficacy and Safety of Relugolix in Women With Heavy Menstrual Bleeding Associated with Uterine Fibroidsheavy menstrual bleeding associated with uterine fibroidsMedDRA version: 20.0Level: LLTClassification code 10027331Term: Menstrual flow alteredSystem Organ Class: 100000004872MedDRA version: 20.0Level: LLTClassification code 10046783Term: Uterine fibroidSystem Organ Class: 100000004864EUCTR2017-003310-74-CZMyovant Sciences GmbH600
进行中（未招募）
1 期
A study to evaluate the long term Efficacy and Safety of Relugolix in Women With Heavy Menstrual Bleeding Associated with Uterine Fibroidsheavy menstrual bleeding associated with uterine fibroidsMedDRA version: 20.0Level: LLTClassification code 10027331Term: Menstrual flow alteredSystem Organ Class: 100000004872MedDRA version: 21.1Level: LLTClassification code 10046783Term: Uterine fibroidSystem Organ Class: 100000004864EUCTR2017-003310-74-GBMyovant Sciences GmbH600