EndometriosisPhase 2NCT01458301
Efficacy and Safety 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 determine the efficacy and safety of TAK-385, once daily (QD), for 12 weeks in women with endometriosis. 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
- 487 participants
- Where
- 69 sitesJapan
- Study dates
- Oct 2011to Aug 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
- Premenopausal women
- The participants must have dysmenorrhea and pelvic pain associated with endometriosis.
- The participant has experienced a regular menstrual cycle.
- The participant has been diagnosed with endometriosis by method a), b), or c).
- Laparotomy
- Laparoscopy
- Chocolate cyst of the ovary confirmed by MRI
Who cannot join
- Participants diagnosed with measurable uterine fibroids with the longest diameter of 3 cm or larger
- Participants with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis
- Participants with a previous or current history of thyroid dysfunction
- Participants with current or previous history of pelvic inflammatory disease
- Participants with positive PAP smear test result conducted
- Participants with a history of panhysterectomy or bilateral oophorectomy
Show all 17Show fewer
- Participants judged by investigator to have marked abnormal uterine bleeding or anovulatory bleeding
- Participants with a previous or current history of a malignant tumor
- Participants who have been treated with any of the following drugs: anticoagulant drug, antiplatelet drug, tranexamic acid, selective estrogen receptor modulator (SERM), activated vitamin D, other vitamin D, calcitonin, ipriflavone, steroid hormone, vitamin K, teriparatide,or denosumab
- Participants who have been treated with any of the following drugs: oral contraceptive and sex hormone preparation, gonadotropin-releasing hormone (GnRH) analogue, dienogest, danazol, or aromatase inhibitor
- Participants who have been treated with bisphosphonate preparation
- Participants with a previous or current history of hypersensitivity or allergy to Leuplin, synthetic LH-RH, LH-RH derivatives, gelatin-containing formulations or food containing gelatin, or have a previous or current history of severe hypersensitivity or severe allergy to other drugs
- Participants with non-diagnosable abnormal genital bleeding
- Participants with a previous or current history of osteoporosis, bone mass loss, or other metabolic bone diseases
- Participants with clinically significant cardiovascular disease or uncontrollable hypertension
- Participants judged by investigator to be inappropriate to participate in this study based on the 12-lead electrocardiogram (ECG) findings
- Participants with active liver disease or jaundice, or with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin > 1.5 times the upper limit of normal (ULN) in the clinical laboratory tests
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, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of TAK-385 10, 20, and 40 mg (p.o.) in the Treatment of Endometriosis
The purpose of this study is to determine the efficacy and safety of TAK-385, once daily (QD), for 12 weeks in women with endometriosis.
Read the detailed description
This Phase II, multicenter, double-blind, randomized, parallel-group, placebo-controlled study will evaluate the efficacy and safety of 3 dose levels (10, 20, and 40 mg) of TAK-385 following oral administration for 12 weeks in women with endometriosis.
- 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 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.
Score for pelvic pain as measured by the Visual Analogue Scale (VAS)
Pelvic pain will be assessed using the VAS as pain evaluation scale.
Measured: Week 12 (one menstrual cycle)
Secondary outcomes (10)
VAS Score for Pelvic Pain
Pelvic pain will be assessed using the VAS as pain evaluation scale
Measured: Up to Week 12.
VAS Score for Dyspareunia
Dyspareunia will be assessed using the VAS as pain evaluation scale
Measured: Up to Week 12.
Bone Mineral Density
Measured by Dual-energy X-ray absorptiometry (DXA)
Measured: Up to Week 12.
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 12.
Body Weight
Measured: Up to Week 12.
Electrocardiograms.
Measured: Up to Week 12.
Number of Participants with Markedly Abnormal Standard Safety Laboratory Values
Measured: Up to Week 24
Serum NTx
NTx is one of the biochemical bone metabolism markers
Measured: Up to Week 12.
Serum BAP
BAP is one of the biochemical bone metabolism markers
Measured: Up to Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionAug 2013
- Study completionAug 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 487 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458301
- Sponsor's protocol ID
- TAK-385/CCT-101
- Other IDs
- U1111-1123-6890, JapicCTI-111588
- Status last verified
- Feb 2014
- First submitted
- 31 Aug 2011
- Last updated
- 25 Feb 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 receptor antagonist, reduces endometriosis-associated pain in a dose-response manner: a randomized, double-blind, placebo-controlled study. Fertil Steril. 2021 Feb;115(2):397-405. doi: 10.1016/j.fertnstert.2020.07.055. Epub 2020 Sep 7.
PubMed 32912633
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of TAK-385 10, 20, and 40 mg (p.o.) in the Treatment of Endometriosis
- ClinicalTrials.gov ID
- NCT01458301
- Acronym / sponsor ID
- TAK-385/CCT-101
- Conditions
- Endometriosis
- Keywords
- Drug Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 487 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 24 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 determine the efficacy and safety of TAK-385, once daily (QD), for 12 weeks in women with endometriosis.
Detailed description
This Phase II, multicenter, double-blind, randomized, parallel-group, placebo-controlled study will evaluate the efficacy and safety of 3 dose levels (10, 20, and 40 mg) of TAK-385 following oral administration for 12 weeks in women with endometriosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- 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 (7 listed)
- Premenopausal women
- The participants must have dysmenorrhea and pelvic pain associated with endometriosis.
- The participant has experienced a regular menstrual cycle.
- The participant has been diagnosed with endometriosis by method a), b), or c).
Key exclusion criteria (17 listed)
- Participants diagnosed with measurable uterine fibroids with the longest diameter of 3 cm or larger
- Participants with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis
- Participants with a previous or current history of thyroid dysfunction
- Participants with current or previous history of pelvic inflammatory disease
- Participants with positive PAP smear test result conducted
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 injection, subcutaneously, once every 4 weeks for up to 12 weeks | Drug | Leuplin |
Primary outcome
Score for pelvic pain as measured by the Visual Analogue Scale (VAS)
Time frame: Week 12 (one menstrual cycle)
Pelvic pain will be assessed using the VAS as pain evaluation scale.
10 secondary outcomes
VAS Score for Pelvic Pain
Time frame: Up to Week 12.
VAS Score for Dyspareunia
Time frame: Up to Week 12.
Bone Mineral Density
Time frame: Up to Week 12.
Treatment-emergent Adverse Events.
Time frame: Up to Week 16
Vital Signs
Time frame: Up to Week 12.
Body Weight
Time frame: Up to Week 12.
Electrocardiograms.
Time frame: Up to Week 12.
Number of Participants with Markedly Abnormal Standard Safety Laboratory Values
Time frame: Up to Week 24
Serum NTx
Time frame: Up to Week 12.
Serum BAP
Time frame: Up to Week 12.
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 25 Feb 2014.
- Derived from this study: PubMed 32912633Osuga Y, Seki Y, Tanimoto M, Kusumoto T, Kudou K, Terakawa N. Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces endometriosis-associated pain in a dose-response manner: a randomized, double-blind, placebo-controlled study. Fertil Steril. 2021 Feb;115(2):397-405. doi: 10.1016/j.fertnstert.2020.07.055. Epub 2020 Sep 7.
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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.
Senior Director 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 7 inclusion and 17 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 25 Feb 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?
Score for pelvic pain as measured by the Visual Analogue Scale (VAS) (time frame: Week 12 (one menstrual cycle)). 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 NCT01458301, 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 25 Feb 2014.