Endometriosis
Conditions
Keywords
Drug Therapy
Brief summary
The purpose of this study is to compare the long term safety and efficacy of TAK-385, once daily (QD) following continued administration in participants who completed a Phase II dose-finding study.
Detailed description
This study is a long-term extension study for evaluation of the safety and efficacy of TAK-385 following administration for 24 weeks (calculated from Visit 3 in the TAK-385/CCT-101 study) in participants from the Phase II dose-finding study (TAK-385/CCT-101 study).
Interventions
DRUGPlacebo
TAK-385 placebo-matching tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
DRUGTAK-385
TAK-385 10 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
DRUGLeuprorelin acetate
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
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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 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 participants.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum BAP | Up to Week 24 | BAP is one of the biochemical bone metabolism markers |
| Laboratory Values | Up to Week 24 | — |
| Serum NTx | Up to Week 24 | NTx is one of the biochemical bone metabolism markers |
| Bone Mineral Density | Up to Week 24. | Measured by Dual-energy X-ray absorptiometry (DXA) |
| Treatment-emergent Adverse Events | Up to Week 16 | 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 | Up to Week 24 | Vital signs will include body temperature, sitting blood pressure and pulse (bpm). |
| Body Weight | Up to Week 24 | — |
| Electrocardiograms | Up to Week 24. | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS Score for Dyspareunia | Up to Week 24 | Dyspareunia will be assessed using the VAS as pain evaluation scale |
| Visual Analogue Scale (VAS) Score for Pelvic Pain | Up to Week 24 | Pelvic pain will be assessed using the VAS as pain evaluation scale |
Countries
Japan
Outcome results
None listed