Endometriosis
Conditions
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Participants who have completed TAK-385/CCT-101 study
Exclusion criteria
Exclusion criteria: 1. Participants who had an adverse event in TAK-385/CCT-101 study which makes continued administration of the study drug diffficult 2. Participants who became unable to comply with the protocol due to onset of a new disease, symptom, finding, or aggravation of clinical laboratory findings 3. Participants in whom investigator deems that the study drug shows no efficacy based on the level of pain, menstruation status, and the status of analgesic drug intake in TAK-385/CCT-101 study, or that study continuation represents an unacceptable risk 4. Participants in whom investigator deems that study continuation is difficult due to the occurrence of low estrogen symptoms in TAK-385/CCT-101 study which were attributed to the pharmacological effects of the study drug, taking into account the level and frequency of the adverse events etc. as well as the risk-benefit of subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone mineral density, adverse events, vital signs, body weight, 12-lead ECG, clinical laboratory tests Bone mineral density will be measured by a dual-energy X-ray absorptiometry (DEXA) scan. Other parameters will be assessed based on the results of clinical laboratory tests, etc. Timeframe:During treatment period and follow-up period | — |
Secondary
| Measure | Time frame |
|---|---|
| The Visual Analogue Scale (VAS) score for pelvic pain and VAS score for dyspareunia Pelvic pain and dyspareunia will be assessed using the VAS as pain evaluation scale. Timeframe:Treatment period | — |
Outcome results
None listed