Clinical trial NCT01452685: A Long-term Extension Study of TAK-385 in the Treatment of Endometriosis
Official title: A Phase II, Multicenter, Long-term Extension Study to Compare the Safety and Efficacy of TAK-385 (10, 20, and 40 mg) Following Oral Administration for 12 Weeks or More in the Treatment of Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-10-17
Enrollment: 397
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Bone Mineral Density
timeFrame: Up to Week 24.
measure: Treatment-emergent Adverse Events
timeFrame: Up to Week 16
measure: Vital Signs
timeFrame: Up to Week 24
measure: Body Weight
timeFrame: Up to Week 24
measure: Electrocardiograms
timeFrame: Up to Week 24.
measure: Laboratory Values
timeFrame: Up to Week 24
measure: Serum NTx
timeFrame: Up to Week 24
measure: Serum BAP
timeFrame: Up to Week 24
Secondary outcomes:
measure: Visual Analogue Scale (VAS) Score for Pelvic Pain
timeFrame: Up to Week 24
measure: VAS Score for Dyspareunia
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
state: Aichi
city: Chiba-shi
country: Japan
state: Chiba
city: Funabashi-shi
country: Japan
state: Chiba
city: Ichihara-shi
country: Japan
state: Chiba
city: Yachiyo-shi
country: Japan
state: Chiba
city: Nihama-shi
country: Japan
state: Ehime
city: Fukui-shi
country: Japan
state: Fukui
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Iizuka-shi
country: Japan
state: Fukuoka
city: Kitakyushu-shi
country: Japan
state: Fukuoka
city: Onga-gun
country: Japan
state: Fukuoka
city: Yanagawa-shi
country: Japan
state: Fukuoka
city: Koriyama-shi
country: Japan
state: Fukushima
city: Takayama-shi
country: Japan
state: Gifu
city: Takasaki-shi
country: Japan
state: Gunma
city: Hirosima-shi
country: Japan
state: Hirosima
city: Ebetsu-shi
country: Japan
state: Hokkaido
city: Ishikari-shi
country: Japan
state: Hokkaido
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Amagasaki-shi
country: Japan
state: Hyogo
city: Kako-gun
country: Japan
state: Hyogo
city: Kawanishi-shi
country: Japan
state: Hyogo
city: Kobe-shi
country: Japan
state: Hyogo
city: Kanazawa-shi
country: Japan
state: Ishikawa
city: Marugame-shi
country: Japan
state: Kagawa
city: Kagoshima-shi
country: Japan
state: Kagoshima
city: Hiratsuka-shi
country: Japan
state: Kanagawa
city: Kamakura-shi
country: Japan
state: Kanagawa
city: Kawasaki-shi
country: Japan
state: Kanagawa
city: Yamato-shi
country: Japan
state: Kanagawa
city: Yokohama-shi
country: Japan
state: Kanagawa
city: Nankoku-shi
country: Japan
state: Kochi
city: Kumamoto-shi
country: Japan
state: Kumamoto
city: Kyoto-shi
country: Japan
state: Kyoto
city: Sendai-shi
country: Japan
state: Miyagi
city: Matsumoto-shi
country: Japan
state: Nagano
city: Nagano-shi
country: Japan
state: Nagano
city: Suzaka-shi
country: Japan
state: Nagano
city: Nara-shi
country: Japan
state: Nara
city: Oita-shi
country: Japan
state: Oita
city: Kurashiki-shi
country: Japan
state: Okayama
city: Okayama-shi
country: Japan
state: Okayama
city: Hirakata-shi
country: Japan
state: Osaka
city: Ibaraki-shi
country: Japan
state: Osaka
city: Ikeda-shi
country: Japan
state: Osaka
city: Osaka-shi
country: Japan
state: Osaka
city: Sakai-shi
country: Japan
state: Osaka
city: Suita-shi
country: Japan
state: Osaka
city: Tondabayashi-shi
country: Japan
state: Osaka
city: Toyonaka-shi
country: Japan
state: Osaka
city: Iruma-shi
country: Japan
state: Saitama
city: Kusatsu-shi
country: Japan
state: Shiga
city: Hamamatsu-shi
country: Japan
state: Shizuoka
city: Numazu-shi
country: Japan
state: Shizuoka
city: Yaizu-shi
country: Japan
state: Shizuoka
city: Komatsushima-shi
country: Japan
state: Tokushima
city: Naruto-shi
country: Japan
state: Tokushima
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Chiyoda-ku
country: Japan
state: Tokyo
city: Chuo-ku
country: Japan
state: Tokyo
city: Itabashi-ku
country: Japan
state: Tokyo
city: Machida-shi
country: Japan
state: Tokyo
city: Minato-ku
country: Japan
state: Tokyo
city: Ohta-ku
country: Japan
state: Tokyo
city: Setagaya-ku
country: Japan
state: Tokyo
city: Shinagawa-ku
country: Japan
state: Tokyo
city: Suginami-ku
country: Japan
state: Tokyo
city: Toyama-shi
country: Japan
state: Toyama
city: Yamaguchi-shi
country: Japan
state: Yamaguchi
Study officials:
affiliation: Takeda
name: VP Clinical Science Strategy
role: STUDY_DIRECTOR
References:
citation: 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.