EndometriosisPhase 2NCT01452685
A Long-term Extension Study of TAK-385 in the Treatment of Endometriosis
A Phase 2 study testing TAK-385 and Leuprorelin acetate in people with Endometriosis, run by Takeda at 69 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- TAK-385 and Leuprorelin acetate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 397 participants
- Where
- 69 sitesJapan
- Study dates
- Mar 2012to Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Participants who have completed TAK-385/CCT-101 study
Who cannot join
- Participants who had an adverse event in TAK-385/CCT-101 study which makes continued administration of the study drug difficult
- Participants who became unable to comply with the protocol due to onset of a new disease, symptom, finding, or aggravation of clinical laboratory findings
- 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
- 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.
Trial locations and contacts
69 sites in 1 country.
69 sites in 1 country
Japan69 sites
Study site
Amagasaki-shi, Hyōgo
Study site
Bunkyo-ku, Tokyo
Study site
Chiba, Chiba
Study site
Chiyoda-ku, Tokyo
Study site
Chuo-ku, Tokyo
Study site
Ebetsu-shi, Hokkaido
Study site
Fukui-shi, Fukui
Study site
Fukuoka, Fukuoka
Study site
Funabashi-shi, Chiba
Study site
Hamamatsu, Shizuoka
Study site
Hirakata-shi, Osaka
Study site
Hiratsuka-shi, Kanagawa
Study site
Hirosima-shi, Hiroshima
Study site
Ibaraki-shi, Osaka
Study site
Ichihara-shi, Chiba
Study site
Iizuka-shi, Fukuoka
Study site
Ikeda-shi, Osaka
Study site
Iruma-shi, Saitama
Study site
Ishikari-shi, Hokkaido
Study site
Kagoshima, Kagoshima-ken
Study site
Kako-gun, Hyōgo
Study site
Kamakura-shi, Kanagawa
Study site
Kanazawa, Ishikawa-ken
Study site
Kawanishi-shi, Hyōgo
Study site
Kawasaki-shi, Kanagawa
Study site
Kitakyushu-shi, Fukuoka
Study site
Kobe, Hyōgo
Study site
Komatsushima-shi, Tokushima
Study site
Koriyama-shi, Fukushima
Study site
Kumamoto, Kumamoto
Study site
Kurashiki-shi, Okayama-ken
Study site
Kusatsu-shi, Shiga
Study site
Kyoto, Kyoto
Study site
Machida-shi, Tokyo
Study site
Marugame-shi, Kagawa-ken
Study site
Matsumoto-shi, Nagano
Study site
Minato-ku, Tokyo
Study site
Nagano, Nagano
Study site
Nagoya, Aichi-ken
Study site
Nankoku-shi, Kochi
Study site
Nara, Nara
Study site
Naruto-shi, Tokushima
Study site
Nihama-shi, Ehime
Study site
Numazu-shi, Shizuoka
Study site
Ohta-ku, Tokyo
Study site
Ōita, Oita Prefecture
Study site
Okayama, Okayama-ken
Study site
Onga-gun, Fukuoka
Study site
Osaka, Osaka
Study site
Sakai-shi, Osaka
Study site
Sapporo, Hokkaido
Study site
Sendai, Miyagi
Study site
Setagaya-ku, Tokyo
Study site
Shinagawa-ku, Tokyo
Study site
Suginami-ku, Tokyo
Study site
Suita-shi, Osaka
Study site
Suzaka-shi, Nagano
Study site
tabashi City, Tokyo
Study site
Takasaki-shi, Gunma
Study site
Takayama-shi, Gifu
Study site
Tondabayashi-shi, Osaka
Study site
Toyama, Toyama
Study site
Toyonaka-shi, Osaka
Study site
Yachiyo-shi, Chiba
Study site
Yaizu-shi, Shizuoka
Study site
Yamaguchi, Yamaguchi
Study site
Yamato-shi, Kanagawa
Study site
Yanagawa-shi, Fukuoka
Study site
Yokohama, Kanagawa
About this study
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
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.
Read the 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).
- Conditions
- Endometriosis
- Being tested
- Placebo, TAK-385, Leuprorelin acetate
- Keywords
- Drug Therapy
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
TAK-385 placebo-matching tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
TAK-385Drug
TAK-385 10 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
TAK-385Drug
TAK-385 20 mg, tablets orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
TAK-385Drug
TAK-385 40 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
Leuprorelin acetateDrug
Also called Leuplin
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
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| TAK-385 10 mg QD | Experimental | Not described Receives: Drug: TAK-385 |
| TAK-385 20 mg QD | Experimental | Not described Receives: Drug: TAK-385 |
| TAK-385 40 mg QD | Experimental | Not described Receives: Drug: TAK-385 |
| Leuplin | Other | Not described Receives: Drug: Leuprorelin acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density
Measured by Dual-energy X-ray absorptiometry (DXA)
Measured: 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)
Measured: Up to Week 16
Vital Signs
Vital signs will include body temperature, sitting blood pressure and pulse (bpm).
Measured: Up to Week 24
Body Weight
Measured: Up to Week 24
Electrocardiograms
Measured: Up to Week 24.
Laboratory Values
Measured: Up to Week 24
Serum NTx
NTx is one of the biochemical bone metabolism markers
Measured: Up to Week 24
Serum BAP
BAP is one of the biochemical bone metabolism markers
Measured: Up to Week 24
Secondary outcomes (2)
Visual Analogue Scale (VAS) Score for Pelvic Pain
Pelvic pain will be assessed using the VAS as pain evaluation scale
Measured: Up to Week 24
VAS Score for Dyspareunia
Dyspareunia will be assessed using the VAS as pain evaluation scale
Measured: Up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startMar 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- VP Clinical Science Strategy, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452685
- Sponsor's protocol ID
- TAK-385/OCT-101
- Other IDs
- U1111-1123-6973, JapicCTI-11589
- Status last verified
- May 2014
- First submitted
- 31 Aug 2011
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34154590
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01452685
- Acronym / sponsor ID
- TAK-385/OCT-101
- Conditions
- Endometriosis
- Keywords
- Drug Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| TAK-385 10 mg QD | Experimental | Drug: TAK-385 |
| TAK-385 20 mg QD | Experimental | Drug: TAK-385 |
| TAK-385 40 mg QD | Experimental | Drug: TAK-385 |
| Leuplin | Other | Drug: Leuprorelin acetate |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Participants who have completed TAK-385/CCT-101 study
Key exclusion criteria (4 listed)
- Participants who had an adverse event in TAK-385/CCT-101 study which makes continued administration of the study drug difficult
- Participants who became unable to comply with the protocol due to onset of a new disease, symptom, finding, or aggravation of clinical laboratory findings
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboTAK-385 placebo-matching tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks. | Drug | Placebo |
| TAK-385TAK-385 10 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks. | Drug | TAK-385 10 mg QD |
| TAK-385TAK-385 20 mg, tablets orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks. | Drug | TAK-385 20 mg QD |
| TAK-385TAK-385 40 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks. | Drug | TAK-385 40 mg QD |
| Leuprorelin acetateAlso: LeuplinTAK-385 placebo-matching tablets, orally, once daily and leuprorelin acetate 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks | Drug | Leuplin |
Primary outcome
Bone Mineral Density
Time frame: Up to Week 24.
Measured by Dual-energy X-ray absorptiometry (DXA)
Treatment-emergent Adverse Events
Time frame: 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
Time frame: Up to Week 24
Vital signs will include body temperature, sitting blood pressure and pulse (bpm).
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
Time frame: Up to Week 24
NTx is one of the biochemical bone metabolism markers
Serum BAP
Time frame: Up to Week 24
BAP is one of the biochemical bone metabolism markers
2 secondary outcomes
Visual Analogue Scale (VAS) Score for Pelvic Pain
Time frame: Up to Week 24
VAS Score for Dyspareunia
Time frame: Up to Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
- Derived from this study: PubMed 34154590Osuga 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VP Clinical Science Strategy study director
Takeda
69 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAK-385 and Leuprorelin acetate in people with Endometriosis, run by Takeda at 69 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Mineral Density (time frame: Up to Week 24.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01452685, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2014.