EUCTR2020-000090-25-IT进行中（未招募）1 期
A Phase IIa, Multicenter, Randomized, Double-Blind, Parallel- Group, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy and Safety of Orally Administered TU2670 in Subjects with Moderate to Severe Endometriosis-Associated Pain. - LUNA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- •For the screening phase:
- •1. Independent Ethics Committee (IEC)-approved written informed consent/assent and privacy language as per national regulations must
- •be voluntarily obtained from the subject.
- •2. Premenopausal female subject, 18 to 45 years, inclusive
- •3. Subject has moderate to severe endometriosis-related pain likely to meet inclusion criteria 13 and 14 in the opinion of the Investigator.
- •4. Subject has documented surgically (laparoscopy, laparotomy) diagnosed endometriosis within the last 10 years before signing informed consent and has recurrent or persistent endometriosis symptoms
- •5. Subject reports regular menstrual cycles of 24 to 38 days inclusive for at least the last 2 years.
- •6. Subject must agree not to breastfeed starting at screening and throughout the study period, and for 28 days after the final study drug
- •administration.
- •7. Subject must agree to use adequate non-hormonal contraceptive method(s) to prevent pregnancy. Contraception must be used
- •throughout the study starting at screening or before until the end of their study participation. Non-hormonal contraceptive methods are defined as:
- •A. Subject has undergone surgical sterilization, or B. Subject's sexual partner has been surgically sterilized (at least 12
- •weeks before signing informed consent), or C. Dual non-hormonal contraception method:
- •i) Condom with spermicide
- •ii) Diaphragm with spermicide (with condom)
- •iii) Cervical cap with spermicide (with condom)
- •iv) Vaginal sponge impregnated with spermicide, used with a condom
- •8. Have a body mass index (BMI) between 18 and 36 kg/m2, inclusive
- •In addition for the randomization:
- •9. Subject has an mB&B scale total score of =6 with a score of at least 2
- •for dysmenorrhea and at least 2 for non-menstrual pelvic pain (NMPP).
- •10. Subject is suffering from endometriosis-associated dysmenorrhea and NMPP (Numeric Rating Scale [NRS] >0 in both domains) with at least 1 of the following:
- •¿ Moderate to severe dysmenorrhea: Mean NRS pain score =4 (over all menstrual days)
- •¿ Moderate NMPP: NRS pain score =4 on at least 7 non-menstrual days (not necessarily consecutively)
- •¿ Severe NMPP: NRS pain score =7 on at least 3 non-menstrual days (not necessarily consecutively)
- •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 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. used hormonal contraceptives or other drugs with effects on gynecological endocrinology within 12 weeks prior to the start of e-diary
- •completion, depot medroxyprogesterone acetate (DMPA) or danazol within 12 weeks prior to the start of e-diary completion, GnRH-agonists
- •or antagonists within 12 weeks prior to the start of e-diary completion, GnRH-agonist or antagonist depot-products within 24 weeks prior to the
- •start of e-diary completion, or is using a non-hormonal (copper) intrauterine device. 2. has been nonresponsive to GnRH-agonist or antagonist therapy for the management of endometriosis. 3. has had a pregnancy within 12 weeks prior to signing informed consent, is currently breastfeeding, or has the intention to become pregnant during the study. 4. has had surgery (including diagnostic laparoscopy) for endometriosis
- •within the 8 weeks prior to screening visit. 5. has a known concurrent uterine myoma or other pelvic lesions >3 cm diameter.
- •6. has undiagnosed abnormal vaginal bleeding. 7. has concurrent or previous pelvic infection within 8 weeks before signing informed consent.
- •8. has documented, concurrent disease with chronic abdominal pain of non-endometriosis origin (eg, irritable bowel syndrome [IBS], interstitial
- •cystitis, adenomyosis) or any concurrent condition requiring evaluation or therapy during the course of the study that may induce abdominal
- •pain. 9. Have had a hysterectomy or oophorectomy. 10. Have pelvic pain that is not caused by endometriosis. 11. Have a previous or current history of thyroid dysfunction. 12. has a pituitary adenoma. 13. has used drugs with negative effects on BMD within 12 weeks prior to start of e-diary completion including use of systemic steroids on a chronic or regular basis. 14. has concurrent or previous osteoporosis, bone loss, other metabolic bone diseases, parathyroid disease or abnormalities of the spine or hip that may affect BMD measurement, or spine or femur BMD T-scores below -1.5 by DXA performed at screening. 15. has active malignancy or history of malignancy during the 5 years before signing informed consent. A history of cutaneous squamous cell
- •carcinoma or a basal cell carcinoma is allowed if considered cured at the time of informed consent. 16. has severe renal function deterioration: estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 (Modification of Diet in Renal Disease [MDRD], based on serum creatinine).
- •17. has an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2×upper limit of normal (ULN), or total bilirubin >1.5×ULN.
- •18. has any unstable medical condition or chronic disease, investigation or laboratory abnormality, which in the Investigator's opinion, makes
- •the subject unsuitable for study participation. 19. Screening 12-lead ECG showing clinically significant abnormalities and/or QT interval corrected using Fridericia's formula (QTcF) >470 msec. 20. has a chronic condition that requires the regularly use of analgesics and/or corticosteroids (such as rheumatoid arthritis) that may influence the assessment of endometriosis pelvic pain. 21. has a contraindication or known allergy for study drug or ibuprofen
- •or any components (eg, lactose or galactose) of these. 22. Have a clinically significant cardiovascular disease or uncontrollable hypertension. 23. Have a previous or current history of hypersensitivity or allergy to gelatin-containing formulations or food containing gelatin (including lifestyle and/or dietary restrictions that prec
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