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

Tanabe Pharma America, Inc.

Status and phase: Completed; Phase 2

Conditions: Vasomotor Symptoms (VMS)

Treatments: Drug: MT-8554

Study type: Interventional

Funder types: Industry

Identifiers

NCT03541200

MT-8554-A02

Details and patient eligibility

About

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

Enrollment: 190 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

190 participants in 1 patient group

Open Label

Experimental group

Description:

MT-8554

Treatment:

Drug: MT-8554