Conditions: Menopause Hot Flashes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 375
Healthy volunteers: no

Brief 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.

Detailed description:
This is a Phase II randomized, double-blind, placebo-controlled study for dose selection in postmenopausal women with moderate to severe VMS, defined as follows:

* Moderate: sensation of heat with sweating, able to continue activity
* Severe: sensation of heat with sweating, causing cessation of activity This study is comprised of a screening period, a run-in period and a 12-week double-blind treatment period.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: MT-8554 1mg intervention 2: MT-8554 5mg intervention 3: MT-8554 10mg intervention 4: Placebo
Intervention descriptions: intervention 1: MT-8554 1mg QD, oral, 12 weeks intervention 2: MT-8554 5mg QD, oral, 12 weeks intervention 3: MT-8554 10mg QD, oral, 12 weeks intervention 4: Placebo QD, oral, 12 weeks

Protocol document:
Prot_000.pdf: 





















































































































































SAP_001.pdf: