Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-02-28 @ 8:47 PM
Study NCT ID:
NCT03291067
Status:
COMPLETED
Last Update Posted:
2023-05-15
First Post:
2017-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women
Sponsor:
Tanabe Pharma America, Inc.
Organization:
Study Overview
Official Title:
A Randomized, Double Blind, Placebo Controlled Study to Assess the Effect of MT-8554 on the Frequency and Severity of Vasomotor Symptoms in Postmenopausal Women
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: