CompletedPhase 2

Long-term Safety and Efficacy Study of MT-8554 in Postmenopausal Women With Vasomotor Symptoms

United States190 participantsStarted 2018-04-18

Plain-language 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

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Percentage of Subjects With Adverse Events

Timeframe: 52 Weeks

Percentage of Subjects With Serious Adverse Events

Timeframe: 52 Weeks

Percentage of Subjects With Clinical Laboratory Tests Abnormalities

Timeframe: 52 Weeks

Change in Blood Pressure

Timeframe: Baseline and 52 Weeks

Change in Heart Rate

Timeframe: Baseline and 52 Weeks

Change in ECG Parameters

Timeframe: Baseline and 52 Weeks

Change in Endometrial Thickness as Measured by Transvaginal Ultrasound

Timeframe: Baseline and 52 Weeks

Percentage of Participants With Endometrial Hyperplasia as Measured by Endometrial Biopsy

Timeframe: 52 Weeks

Trial details

NCT IDNCT03541200

SponsorTanabe Pharma America, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-11-15

Results submitted2022-06-26

View on ClinicalTrials.gov More Vasomotor Symptoms (VMS) trials