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A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of MT-8554 in Female Subjects Experiencing Vasomotor Symptoms

NCT ID: NCT02803268

Last Updated: 2025-12-22

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-01-31

Brief Summary

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A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of MT-8554 in Female Subjects Experiencing Vasomotor Symptoms

Detailed Description

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Conditions

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Vasomotor Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MT-8554 low dose

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.

Group Type EXPERIMENTAL

MT-8554 low dose

Intervention Type DRUG

Placebo

Intervention Type DRUG

MT-8554 middle dose

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.

Group Type EXPERIMENTAL

MT-8554 middle dose

Intervention Type DRUG

Placebo

Intervention Type DRUG

MT-8554 high dose

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.

Group Type EXPERIMENTAL

MT-8554 high dose

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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MT-8554 low dose

Intervention Type DRUG

MT-8554 middle dose

Intervention Type DRUG

MT-8554 high dose

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tanabe Pharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Investigational center

City Name, , Germany

Site Status

Countries

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Germany

Other Identifiers

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MT-8554-E04

Identifier Type: -

Identifier Source: org_study_id