Vasomotor SymptomsPhase 1NCT02803268
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of MT-8554 in Female Subjects Experiencing Vasomotor Symptoms
A Phase 1 study testing MT-8554 low dose, MT-8554 middle dose and MT-8554 high dose in people with Vasomotor Symptoms, run by Tanabe Pharma Corporation at 1 site in Germany.
Trial summary
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of MT-8554 in Female Subjects Experiencing Vasomotor Symptoms Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vasomotor Symptoms
- What is being tested?
- MT-8554 low dose, MT-8554 middle dose and MT-8554 high dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2016to Jan 2017
- Phase
- Phase 1
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet one of the following criteria:Woman aged ≥18 years with histologically proven non-metastatic breast cancer (Stages I, II or III) and without evidence of disease / Woman aged ≥40 years who are post-menopausal / Woman aged ≥40 years who are peri-menopausal
- Subjects who have ≥7 Vasomotor Symptoms per day on average
- A body weight of ≥45 kg
Who cannot join
- Participation in more than three clinical studies involving administration of an unlicensed Investigational Medicinal Product in the previous year, or any study within 12 weeks
- Clinically significant endocrine, thyroid, hepatic, respiratory, gastro-intestinal, renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness disorder
- Clinically relevant abnormal medical history, physical findings or laboratory values
Trial locations and contacts
1 site in 1 country.
About this study
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of MT-8554 in Female Subjects Experiencing Vasomotor Symptoms
- Conditions
- Vasomotor Symptoms
- Being tested
- MT-8554 low dose, MT-8554 middle dose, MT-8554 high dose, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-8554 low doseDrug
MT-8554 middle doseDrug
MT-8554 high doseDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| MT-8554 low dose | Experimental | Patients who meet eligibility criteria will be administered once daily either low dose of MT-8554 or a matching Placebo from Day 1 to 14. Receives: Drug: MT-8554 low dose; Drug: Placebo |
| MT-8554 middle dose | Experimental | Patients who meet eligibility criteria will be administered once daily either middle dose of MT-8554 or a matching Placebo from Day 1 to 14. Receives: Drug: MT-8554 middle dose; Drug: Placebo |
| MT-8554 high dose | Experimental | Patients who meet eligibility criteria will be administered once daily either high dose of MT-8554 or a matching Placebo from Day 1 to 14. Receives: Drug: MT-8554 high dose; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability as measured by vital signs
Measured: Up to Day 21
Safety and Tolerability as measured by number of participants with adverse events
Measured: Up to Day 21
Secondary outcomes (3)
Plasma concentration of MT-8554 after dosing
Measured: Up to Day 15
Change from baseline in core body temperature
Measured: Up to Day 14
Frequency of Vasomotor Symptoms
Measured: Up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasomotor SymptomsStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803268
- Sponsor's protocol ID
- MT-8554-E04
- Status last verified
- Dec 2025
- First submitted
- 14 Jun 2016
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of MT-8554 in Female Subjects Experiencing Vasomotor Symptoms
- ClinicalTrials.gov ID
- NCT02803268
- Acronym / sponsor ID
- MT-8554-E04
- Conditions
- Vasomotor Symptoms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 16 Jun 2016 (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.
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of MT-8554 in Female Subjects Experiencing Vasomotor Symptoms
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MT-8554 low dose | Experimental | Drug: MT-8554 low dose, Drug: PlaceboPatients who meet eligibility criteria will be administered once daily either low dose of MT-8554 or a matching Placebo from Day 1 to 14. |
| MT-8554 middle dose | Experimental | Drug: MT-8554 middle dose, Drug: PlaceboPatients who meet eligibility criteria will be administered once daily either middle dose of MT-8554 or a matching Placebo from Day 1 to 14. |
| MT-8554 high dose | Experimental | Drug: MT-8554 high dose, Drug: PlaceboPatients who meet eligibility criteria will be administered once daily either high dose of MT-8554 or a matching Placebo from Day 1 to 14. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must meet one of the following criteria:Woman aged ≥18 years with histologically proven non-metastatic breast cancer (Stages I, II or III) and without evidence of disease / Woman aged ≥40 years who are post-menopausal / Woman aged ≥40 years who are peri-menopausal
- Subjects who have ≥7 Vasomotor Symptoms per day on average
- A body weight of ≥45 kg
Key exclusion criteria (3 listed)
- Participation in more than three clinical studies involving administration of an unlicensed Investigational Medicinal Product in the previous year, or any study within 12 weeks
- Clinically significant endocrine, thyroid, hepatic, respiratory, gastro-intestinal, renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness disorder
- Clinically relevant abnormal medical history, physical findings or laboratory values
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 |
|---|---|---|
| MT-8554 low dose | Drug | MT-8554 low dose |
| MT-8554 middle dose | Drug | MT-8554 middle dose |
| MT-8554 high dose | Drug | MT-8554 high dose |
| Placebo | Drug | MT-8554 high dose, MT-8554 low dose, MT-8554 middle dose |
Primary outcome
Safety and Tolerability as measured by vital signs
Time frame: Up to Day 21
Safety and Tolerability as measured by number of participants with adverse events
Time frame: Up to Day 21
3 secondary outcomes
Plasma concentration of MT-8554 after dosing
Time frame: Up to Day 15
Change from baseline in core body temperature
Time frame: Up to Day 14
Frequency of Vasomotor Symptoms
Time frame: Up to Day 15
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 22 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MT-8554 low dose, MT-8554 middle dose and MT-8554 high dose in people with Vasomotor Symptoms, run by Tanabe Pharma Corporation at 1 site in Germany.
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 3 inclusion and 3 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 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety and Tolerability as measured by vital signs (time frame: Up to Day 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2025.