Phase 2
N=190
Long-term Safety and Efficacy Study of MT-8554 in Postmenopausal Women With Vasomotor Symptoms
Vasomotor Symptoms (VMS)
Bottom Line
View on ClinicalTrials.gov: NCT03541200 ↗Enrolled (actual)
190
Serious AEs
3.2%
Results posted
Oct 2022
Primary outcome: Primary: Percentage of Subjects With Adverse Events — 56.7 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MT-8554 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Tanabe Pharma America, Inc.
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Adverse Events |
56.7 | — |
| PRIMARY Percentage of Subjects With Serious Adverse Events |
3.2 | — |
| PRIMARY Percentage of Subjects With Clinical Laboratory Tests Abnormalities |
15.5 | — |
| PRIMARY Change in Blood Pressure |
1.3; -0.4 | — |
| PRIMARY Change in Heart Rate |
2.6 | — |
| PRIMARY Change in ECG Parameters |
0.4; -0.2; -6.8; -0.6; 1.2 | — |
| PRIMARY Change in Endometrial Thickness as Measured by Transvaginal Ultrasound |
-0.138 | — |
| PRIMARY Percentage of Participants With Endometrial Hyperplasia as Measured by Endometrial Biopsy |
— | — |
| SECONDARY Change in Average Daily Frequency of Moderate to Severe VMS |
-2.71 | — |
| SECONDARY Change in Average Daily Severity Score of Mild to Severe VMS |
-0.325 | — |
Summary
An open-label, long term extension study of MT-8554 in postmenopausal women experiencing moderate to severe vasomotor symptoms who completed Study MT-8554-A01
Eligibility Criteria
Inclusion Criteria
- Signed informed consent to participate in this study.
- Subjects who complete the preceding trial (Study MT-8554-A01) through Week 12.
Exclusion Criteria
- Subjects who meet the withdrawal criteria for the proceeding trial (Study MT-8554-A01)
Data sourced from ClinicalTrials.gov (NCT03541200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.