Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01452685 | A Long-term Extension Study of TAK-385 in the Treatment of Endometriosis | PHASE2 | COMPLETED | 397 | — | — | Mar 1, 2012 | Dec 1, 2013 | May 8, 2014 | 69 | Japan |
| NCT01458301 | Efficacy and Safety of TAK-385 in the Treatment of Endometriosis | PHASE2 | COMPLETED | 487 | — | — | Oct 1, 2011 | Aug 1, 2013 | Feb 25, 2014 | 69 | Japan |
Measured by Dual-energy X-ray absorptiometry (DXA)
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit (Week 16)
Vital signs will include body temperature, sitting blood pressure and pulse (bpm).
NTx is one of the biochemical bone metabolism markers
BAP is one of the biochemical bone metabolism markers
Pelvic pain will be assessed using the VAS as pain evaluation scale.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| TAK-385 10 mg QD | EXPERIMENTAL | - |
| TAK-385 20 mg QD | EXPERIMENTAL | - |
| TAK-385 40 mg QD | EXPERIMENTAL | - |
| Leuplin | OTHER | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | TAK-385 placebo-matching tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks. |
| TAK-385 | DRUG | TAK-385 10 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks. |
| Leuprorelin acetate | DRUG | TAK-385 placebo-matching tablets, orally, once daily and leuprorelin acetate 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks |
Inclusion Criteria: 1\. Participants who have completed TAK-385/CCT-101 study Exclusion Criteria: 1. Participants who had an adverse event in TAK-385/CCT-101 study which makes continued administration of the study drug difficult 2. Participants who became unable to comply with the protocol due to...