EUCTR2017-001632-19-CZ进行中（未招募）1 期
SPIRIT 2: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Administered with and without Low-Dose Estradiol and Norethindrone Acetate in Women with Endometriosis-Associated Pain - SPIRIT 2
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. Has voluntarily signed and dated the informed consent form prior to initiation of any screening or study-specific procedures;
- •2. Is a premenopausal female aged 18 to 50 years old (inclusive) on the day of signing date of the informed consent form;
- •3. By the patient's report, had 2 consecutive regular menstrual cycles (ie, 21 to 35 days in duration) immediately prior to Randomization. For patients who have washed off hormonal contraceptives, the 2 regular cycles must start after the first (withdrawal) bleeding following discontinuation of contraceptives;
- •4. Has agreed to use only study-specified analgesic medications during the study and is not known to be intolerant to these;
- •5. Has a diagnosis of endometriosis and has had, within 10 years prior to signing the informed consent form, surgical or direct visualization and/or histopathologic confirmation of endometriosis, for example, during a laparoscopy or laparotomy;
- •6. During the Screening visit, the patient reports moderate, severe, or very severe pain during the most recent menses and for NMPP in the prior month;
- •7. During the Run-In Period (Days R1 through 35), has at least 24 days of completed eDiary scores;
- •8. During the Run-In Period (Days R1 through R35), has a dysmenorrhea NRS score >= 4.0 on at least 2 days AND
- •a. Mean NMPP NRS score > =2.5 OR
- •b. Mean NMPP NRS score >= 1.25 AND NMPP NRS score >= 5.0 on >= 4.0 days;
- •For patients with fewer than 3 dysmenorrhea scores during Days R1 - R35, dysmenorrhea scores from Days R36 – 70 will be included in the eligibility determination until a total of 3 dysmenorrhea scores from the Run-In Period are available.
- •9. Has menstruated for at least 3 days during the Run-In Period
- •10. 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;
- •11. Has a negative urine pregnancy test at the Screening visit and on the Baseline Day 1 visit;
- •12. Agrees to use contraception during the study and for 30 days following the last dose of study drug. Specifically, agrees to use nonhormonal contraception as described in Section 4.7 consistently during the Screening Period, Run-In Period, and the Randomized Treatment Period and for 30 days following treatment discontinuation. However, the patient is not required to use the specified nonhormonal contraception if she:
- •a. Has a sexual partner(s) who was vasectomized at least 6 months prior to the Screening Period;
- •b. Had a bilateral tubal occlusion (including ligation and blockage methods such as Essure™), at least 6 months prior to the Screening visit (patients with Essure must have prior confirmation of tubal occlusion by hysterosalpingogram and no evidence of post-Essure syndrome” in the investigator’s opinion);
- •c. Is not sexually active with men; periodic sexual relationship(s) with men requires the use of nonhormonal contraception as noted above; or
- •d. Practices total abstinence from sexual intercourse as her preferred lifestyle. Periodic abstinence is not acceptable
- •13. Has an adequate endometrial (aspiration) biopsy performed during the Screening visit or Run-In Period or one that was locally performed within 6 months prior to Screening with results showing no clinically significant endometrial pathology (hyperplasia, polyp, or endometrial cancer);
- •Note 1: Pati
排除标准
- •1. Has a history of chronic pelvic pain that is not caused by endometriosis
- •2. Has had 4 or more prior laparoscopic or open abdominal or pelvic surgical procedure for endometriosis;
- •3. During the Run-In Period, reports NMPP is much better” on the PGIC for NMPP
- •4. Has a transvaginal ultrasound during the Screening visit demonstrating pathology other than endometriosis that could be responsible for or contributing to the patient’s chronic pelvic pain or a clinically significant gynecological disorder determined by the investigator to require further evaluation and/or treatment during the study
- •5. 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
- •6. Has had surgical procedure for treatment of endometriosis within the 3 months prior to the Screening visit
- •7. Has a history of previous non-response of NMPP or dysmenorrhea to GnRH agonists, GnRH antagonists, depot medroxyprogesterone acetate, or aromatase inhibitors based on patient’s report or treating physician’s assessment of chart documentation;
- •8. Has unexplained vaginal bleeding outside of the patient’s regular menstrual period
- •9. Has a weight that exceeds the weight limit of the DXA scanner
- •10. Has bone mineral density z-score < -2.0 at spine, total hip, or femoral neck during the Run-In Period
- •11. Has a gastrointestinal disorder affecting absorption or gastrointestinal motility
- •12. Has used, is using or is anticipated to use prohibited medications;
- •13. Patients receiving selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, or tricyclic antidepressants that have been recently started or undergone recent dose changes. Patients who have been on stable doses for at least 3 months and are anticipated to remain on stable doses during the study (including the Run-In Period) may be enrolled
- •14. Has a history of or currently has osteoporosis, or other metabolic bone disease, hyperparathyroidism, hyperprolactinemia, hyperthyroidism, anorexia nervosa, or low traumatic or atraumatic fracture. A history of successfully treated hyperparathyroidism, hyperprolactinemia, or hyperthyroidism is allowed
- •15. Has a history of the use of bisphosphonates, calcitonin, calcitriol, ipriflavone, teriparatide, denosumab, or any medication other than calcium and vitamin D preparations to treat bone mineral density loss
- •16. Has a systemic autoimmune disease
- •17. Has any contraindication to treatment with low-dose estradiol and norethindrone acetate,
- •18. Has jaundice or known current active liver disease from any cause including hepatitis A (hepatitis A virus [HAV] immunoglobulin M [IgM]), hepatitis B (hepatitis B virus surface antigen [HBsAg]), or hepatitis C (hepatitis C virus [HCV] antibody [Ab] positive, confirmed by HCV ribonucleic acid [RNA])
- •19. On the most recently documented Papanicolaou test, has any of the following cervical pathology: high-grade cervical neoplasia, atypical glandular cells, atypical endocervical cells, or atypical squamous cells favoring high grade. Of note, patients with atypical squamous cells of undetermined significance and low-grade cervical neoplasia may be included in the study if high-risk human papilloma virus testing is negative or if deoxyribonucleic acid (DNA) testing for human papilloma virus 16 and 18 is negative
- •20. Has any clinical laboratory abnormalities during the Screening or Run-In Period
- •21. Has clinic
研究者
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