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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
397
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 10 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
TAK-385 20 mg, tablets orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
Bone Mineral Density
Measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: Up to Week 24.
Treatment-emergent Adverse Events
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)
Time frame: Up to Week 16
Vital Signs
Vital signs will include body temperature, sitting blood pressure and pulse (bpm).
Time frame: Up to Week 24
Body Weight
Time frame: Up to Week 24
Electrocardiograms
Time frame: Up to Week 24.
Laboratory Values
Time frame: Up to Week 24
Serum NTx
NTx is one of the biochemical bone metabolism markers
Time frame: Up to Week 24
Serum BAP
BAP is one of the biochemical bone metabolism markers
Time frame: Up to Week 24
Visual Analogue Scale (VAS) Score for Pelvic Pain
Pelvic pain will be assessed using the VAS as pain evaluation scale
Time frame: Up to Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
TAK-385 40 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
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
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Chiba, Chiba, Japan
Unnamed facility
Funabashi-shi, Chiba, Japan
Unnamed facility
Ichihara-shi, Chiba, Japan
Unnamed facility
Yachiyo-shi, Chiba, Japan
Unnamed facility
Nihama-shi, Ehime, Japan
Unnamed facility
Fukui-shi, Fukui, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Iizuka-shi, Fukuoka, Japan
Unnamed facility
Kitakyushu-shi, Fukuoka, Japan
...and 59 more locations
VAS Score for Dyspareunia
Dyspareunia will be assessed using the VAS as pain evaluation scale
Time frame: Up to Week 24