EUCTR2017-001588-19-PL进行中（未招募）1 期
SPIRIT 1: 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 1
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 >=
- •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 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
- 另有 6 项未显示
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 procedures for endometriosis;
- •3. During the Run-In Period, reports NMPP is much better on the PGIC
- •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
- •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 a 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
- 另有 8 项未显示
研究者
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