A Long-term Extension Study of TAK-385 in the Treatment of Endometriosis
NCT ID: NCT01452685
Last Updated: 2014-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
397 participants
INTERVENTIONAL
2012-03-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Placebo
Placebo
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 QD
TAK-385
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 QD
TAK-385
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 40 mg QD
TAK-385
TAK-385 40 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
Leuplin
Leuprorelin 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
Interventions
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Placebo
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
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
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
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
20 Years
FEMALE
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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VP Clinical Science Strategy
Role: STUDY_DIRECTOR
Takeda
Locations
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Nagoya, Aichi-ken, Japan
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
Countries
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References
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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.
Other Identifiers
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U1111-1123-6973
Identifier Type: REGISTRY
Identifier Source: secondary_id
JapicCTI-11589
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-385/OCT-101
Identifier Type: -
Identifier Source: org_study_id
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