EUCTR2017-004066-10-PL进行中（未招募）1 期
SPIRIT EXTENSION: An International Phase 3 Open-Label, Single-Arm, Safety and Efficacy Extension Study to Evaluate Relugolix Co-Administered with Low-Dose Estradiol and Norethindrone Acetate in Women with Endometriosis-Associated Pain - SPIRIT EXTENSIO
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
- 802
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-601-3101 or MVT-601-3102;
- •2. Has voluntarily signed and dated the informed consent form prior to initiation of any study-specific procedures for MVT-601-3103;
- •Note: Procedures conducted as part of the parent study that also serve as baseline procedures for this study will be done under the informed consent for the parent study.
- •3. Is not expected to undergo gynecological surgery or other surgical procedures for treatment of endometriosis (including ablation, shaving, or excision) during the study, including during the Follow-Up Period, and the patient does not desire such treatment during this time frame;
- •4. Has a negative urine pregnancy test at the Week 24/Baseline visit;
- •5. Has agreed to continue to use only study-specified analgesic medications during the study and is not known to be intolerant to these;
- •6. 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 nonhormonal contraceptive 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 6 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 of post-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 800
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria: None of the following criteria may be true for a patient to be eligible for enrollment into this study.
- •1. Has had a surgical procedure for treatment of endometriosis at any time during the parent study (MVT-601-3101 or MVT-601-3102);
- •2. Has any chronic pain or frequently recurring pain condition, other than endometriosis, that is treated with opioids or requires analgesics for = 7 days per month;
- •3. 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);
- •4. 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;
- •5. Anticipated to use any prohibited medications as detailed in Section 5.10.1;
- •6. 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 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. History of porphyria;
- •7. Has current active liver disease from any cause;
- •8. 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;
- •9. Had any of the following clinical laboratory abnormalities at the parent study Week 20 visit or, if available, any subsequent visit in one of the parent studies (MVT-601-3101 or MVT-601-3102):
- •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);
- •10. Is currently pregnant or lactating, or intends to become pregnant during the study period or within 1 month after the last dose of study drug, or plans to donate ova during the study period or within 2 months after the last dose of study drug;
- •11. 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.
- •12. 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;
- •13. Met a withdrawal criterion in the parent study (MVT-601-3101 or MVT-601-3102).
研究者
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