Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT03291067 · ClinicalTrials.gov registry record · Phase 2

MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women

A Phase 2 study of Menopause Hot Flashes, sponsored by Tanabe Pharma America.

Completed
Registry status
Phase 2
Development phase
375
Enrollment target
20
Study locations

NCT03291067: Completed Phase 2 study of Menopause Hot Flashes, sponsored by Tanabe Pharma America.

NCT03291067 is a Phase 2 study of Menopause Hot Flashes that has completed, run by Tanabe Pharma America. The registered enrollment target is 375 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (182% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT03291067, a Phase 2 study of Menopause Hot Flashes, has completed, sponsored by Tanabe Pharma America.

COMPLETED
Registry status
Phase 2
Development phase
375 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to assess the efficacy and safety of MT-8554 for treatment of vasomotor symptoms (VMS) associated with menopause.

Primary Outcome

The average daily frequency of moderate to severe VMS at a time point (Baseline, Weeks 4 and 12) was the average of the frequency of moderate to severe VMS of available diary days in a 7-day window. Changes in the average daily frequency of moderate to severe VMS at Week 4 and Week 12 compared to baseline were evaluated.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG MT-8554 1mg
  • DRUG MT-8554 5mg
  • DRUG MT-8554 10mg

Study Locations (20)

Florida

  • Research Site - Aventura
  • Research Site - Clearwater
  • Research Site - Crystal River
  • Research Site - Fort Myers
  • Research Site - Hialeah
  • Research Site - Hialeah
  • Research Site - Jacksonville
  • Research Site - Jacksonville
  • Research Site - Jupiter
  • Research Site - Miami
  • Research Site - Miami

California

  • Research Site - Norwalk
  • Research Site - Sacramento
  • Research Site - San Diego

Alabama

  • Research Site - Birmingham
  • Research Site - Dothan

Connecticut

  • Research Site - New London
  • Research Site - New London

Arizona

  • Research Site - Phoenix

Colorado

  • Research Site - Denver

Trial Details

FieldValue
Enrollment Target 375 participants
Start Date 2017-10-09
Est. Completion 2018-11-09
Phase Phase 2
Tanabe Pharma America

18 total trials

What the finished NCT03291067 record still lists

NCT03291067 is an interventional study that assigns participants to a tested intervention. The registered 375 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (182% higher).

The record links to 1 condition, with Menopause Hot Flashes appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT03291067 names 20 study sites across 6 states, led by Florida, California, Alabama.

Frequently Asked Questions

What is clinical trial NCT03291067 about?

NCT03291067 is a clinical study titled "MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women". The purpose of this study is to assess the efficacy and safety of MT-8554 for treatment of vasomotor symptoms (VMS) associated with menopause.

What is the current status of trial NCT03291067?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 375 participants. The study started on 2017-10-09. Estimated completion is 2018-11-09.

What conditions does trial NCT03291067 study?

This clinical trial studies the following conditions: Menopause Hot Flashes.

What interventions are being tested in trial NCT03291067?

The interventions under investigation include: Placebo (DRUG), MT-8554 1mg (DRUG), MT-8554 5mg (DRUG), MT-8554 10mg (DRUG).

Who is sponsoring clinical trial NCT03291067?

This trial is sponsored by Tanabe Pharma America, which has 18 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03291067 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Menopause Hot Flashes

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03291067's enrollment target sits among peer trials

375 116th of 2000 higher than 1,883 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT03686124 · 375 participants · Phase 1

    ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors

  • NCT04059172 · 375 participants · Early Phase 1

    Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain Management

  • NCT04134923 · 375 participants

    Imaging Biomarkers in Preclinical and Symptomatic AD

  • NCT04569747 · 375 participants · Phase 2

    A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT03291067, the US trial registry maintained by the National Library of Medicine. NCT03291067 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.