symptomatic endometriosis MedDRA version: 7 Level: LLT Classification code 10014778
Conditions
Sponsors
Takeda Europe R&D Centre Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pre-menopausal females aged between 18 and 45 years inclusive. 2. New diagnosis of symptomatic endometriosis, or recorded confirmation / re-confirmation by laparoscopy within the 3 years prior to study enrolment. Subjects should have one or more current symptoms comprising dysmenorrhea, pelvic pain, dyspareunia. 3. Body Mass Index (BMI) =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of any form of cancer (other than adequately treated basal cell and squamous cell cancers of the skin). 2. Known to be HIV positive, Hepatitis B surface antigen (HBsAg) or Hepatitis C (HCV) positive. 3. ALT/SGPT >1.5 times ULN, bilirubin >1.5 mg/dL, any hepatic or renal impairment. 4. Hysterectomy and/or bilateral oophorectomy. 5. Abnormal menstrual bleeding unrelated to endometriosis. 6. History of osteoporosis, osteopenia, hypocalcemia or other metabolic bone disease. 7. Known or documented history of severe allergic or idiosyncratic reactions to any drug – including sufugolix (TAK-013). 8. Known history of drug abuse (defined as illicit drug use) or a history of alcohol abuse within the 2 years prior to study enrolment. 9. Use of the following medications in the 3 months prior to study enrolment and throughout the study: GnRH analogues, oral contraceptives, sex hormone medications (including - but not limited to - norethindrone or norethindrone acetate, depomedroxyprogesterone, estrogen preparations, other progestins) and Danazol. Investigators should consider any history or prior use of GnRH analogue therapy in terms of possible bone mineral density loss, and take account of such effects in establishing suitability of subjects for this study. (section 7.10 also lists other concomitant medications prohibited throughout the course of this study.) 10. A positive pregnancy test. 11. Less than 3 months post-partum or post-lactation at onset of therapy within this study. 12. Surgery (other than laparoscopy for endometriosis) planned to occur during the 8 months which follow study screening. 13. Current participation in any clinical trial (marketed product or otherwise) or within the 30 days prior to the study screening. 14. Any disease or disease state that, in the opinion of an investigator, would interfere with the study (e.g. chronic depression requiring treatment).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish, through diary recordings of vaginal bleeding, the frequency of patients achieving suppression of menses during the treatment period from Week 8 (inclusive) to Week 24 (end of the treatment with study medication).;Secondary Objective: To characterise treatment-related changes in serum E2 levels within the study population during the 24-week study treatment and 4-week follow-up periods. To characterise the pharmacokinetics of sufugolix (TAK-013) during the 24-week treatment period - assessed by serial (trough) plasma concentrations of the parent compound within the study population. To evaluate the safety profile of sufugolix (TAK-013) over the study duration.;Primary end point(s): The primary endpoint for efficacy will be the frequency of subjects for whom suppression of menses is achieved during the study treatment period from Week 8 (inclusive) to Week 24 (end of the treatment with study medication). The data will be derived from daily vaginal bleeding scores recorded in diaries by the study patients throughout the treatment period. | — |
Countries
Germany, United Kingdom
Outcome results
None listed