Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1123-6973 | Registry Identifier | WHO | |
| JapicCTI-11589 | Registry Identifier | JapicCTI |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone Mineral Density | Measured by Dual-energy X-ray absorptiometry (DXA) | 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) | Up to Week 16 |
| Vital Signs | Vital signs will include body temperature, sitting blood pressure and pulse (bpm). | Up to Week 24 |
| Body Weight | Up to Week 24 | |
| Electrocardiograms | Up to Week 24. | |
| Laboratory Values | Up to Week 24 | |
| Serum NTx | NTx is one of the biochemical bone metabolism markers | Up to Week 24 |
| Serum BAP | BAP is one of the biochemical bone metabolism markers | Up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) Score for Pelvic Pain | Pelvic pain will be assessed using the VAS as pain evaluation scale | Up to Week 24 |
| VAS Score for Dyspareunia | Dyspareunia will be assessed using the VAS as pain evaluation scale |
Not provided
Inclusion Criteria:
1. Participants who have completed TAK-385/CCT-101 study
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| VP Clinical Science Strategy | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | Japan | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34154590 | Derived | Osuga Y, Seki Y, Tanimoto M, Kusumoto T, Kudou K, Terakawa N. Relugolix, an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, in women with endometriosis-associated pain: phase 2 safety and efficacy 24-week results. BMC Womens Health. 2021 Jun 21;21(1):250. doi: 10.1186/s12905-021-01393-3. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| TAK-385 | Drug | TAK-385 20 mg, tablets orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks. |
|
| TAK-385 | Drug | TAK-385 40 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 |
|
|
| Up to Week 24 |
| Chiba |
| Chiba |
| Japan |
| Funabashi-shi | Chiba | Japan |
| Ichihara-shi | Chiba | Japan |
| Yachiyo-shi | Chiba | Japan |
| Nihama-shi | Ehime | Japan |
| Fukui-shi | Fukui | Japan |
| Fukuoka | Fukuoka | Japan |
| Iizuka-shi | Fukuoka | Japan |
| Kitakyushu-shi | Fukuoka | Japan |
| Onga-gun | Fukuoka | Japan |
| Yanagawa-shi | Fukuoka | Japan |
| Koriyama-shi | Fukushima | Japan |
| Takayama-shi | Gifu | Japan |
| Takasaki-shi | Gunma | Japan |
| Hirosima-shi | Hiroshima | Japan |
| Ebetsu-shi | Hokkaido | Japan |
| Ishikari-shi | Hokkaido | Japan |
| Sapporo | Hokkaido | Japan |
| Amagasaki-shi | Hyōgo | Japan |
| Kako-gun | Hyōgo | Japan |
| Kawanishi-shi | Hyōgo | Japan |
| Kobe | Hyōgo | Japan |
| Kanazawa | Ishikawa-ken | Japan |
| Marugame-shi | Kagawa-ken | Japan |
| Kagoshima | Kagoshima-ken | Japan |
| Hiratsuka-shi | Kanagawa | Japan |
| Kamakura-shi | Kanagawa | Japan |
| Kawasaki-shi | Kanagawa | Japan |
| Yamato-shi | Kanagawa | Japan |
| Yokohama | Kanagawa | Japan |
| Nankoku-shi | Kochi | Japan |
| Kumamoto | Kumamoto | Japan |
| Kyoto | Kyoto | Japan |
| Sendai | Miyagi | Japan |
| Matsumoto-shi | Nagano | Japan |
| Nagano | Nagano | Japan |
| Suzaka-shi | Nagano | Japan |
| Nara | Nara | Japan |
| Ōita | Oita Prefecture | Japan |
| Kurashiki-shi | Okayama-ken | Japan |
| Okayama | Okayama-ken | Japan |
| Hirakata-shi | Osaka | Japan |
| Ibaraki-shi | Osaka | Japan |
| Ikeda-shi | Osaka | Japan |
| Osaka | Osaka | Japan |
| Sakai-shi | Osaka | Japan |
| Suita-shi | Osaka | Japan |
| Tondabayashi-shi | Osaka | Japan |
| Toyonaka-shi | Osaka | Japan |
| Iruma-shi | Saitama | Japan |
| Kusatsu-shi | Shiga | Japan |
| Hamamatsu | Shizuoka | Japan |
| Numazu-shi | Shizuoka | Japan |
| Yaizu-shi | Shizuoka | Japan |
| Komatsushima-shi | Tokushima | Japan |
| Naruto-shi | Tokushima | Japan |
| Bunkyo-ku | Tokyo | Japan |
| Chiyoda-ku | Tokyo | Japan |
| Chuo-ku | Tokyo | Japan |
| Itabashi-ku | Tokyo | Japan |
| Machida-shi | Tokyo | Japan |
| Minato-ku | Tokyo | Japan |
| Ohta-ku | Tokyo | Japan |
| Setagaya-ku | Tokyo | Japan |
| Shinagawa-ku | Tokyo | Japan |
| Suginami-ku | Tokyo | Japan |
| Toyama | Toyama | Japan |
| Yamaguchi | Yamaguchi | Japan |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C561634 | relugolix |
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
Not provided
Not provided