NCT00195455

Brief Summary

The purpose of this study is to evaluate vasomotor symptoms (VMS) control of the continuous regimen 17 b estradiol/trimegestone combination.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2005

Typical duration for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

December 20, 2007

Status Verified

December 1, 2007

First QC Date

September 12, 2005

Last Update Submit

December 17, 2007

Conditions

Postmenopause

Keywords

Postmenopause

Outcome Measures

Primary Outcomes (1)

  • To assess vasomotor symptoms control with a continuous regimen of 17 b estradiol 1mg and Trimegestone (TMG) 0.125 mg.

Secondary Outcomes (2)

  • Study bleeding patterns throughout the treatment period (6 months)

  • Evaluate changes in the Menopause-Specific Quality of Life Questionnaire

Interventions

TrimegestoneDRUG
17b EstradiolDRUG

Eligibility Criteria

Age45 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Generally healthy postmenopausal women 45 to 55 years of age inclusive, with at least 1 year of natural occurring amenorrhea, with vasomotor symptoms, with at least 4 hot flushes per day
  • Intact uterus

You may not qualify if:

  • Known or suspected breast carcinoma or estrogen-dependent neoplasm
  • Undiagnosed abnormal genital bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Guadalajara, Jalisco, 44340, Mexico

Location

Unknown Facility

Monterrey, N.L., 64000, Mexico

Location

Unknown Facility

Monterrey, N.L., 64460, Mexico

Location

Unknown Facility

Mexico City, 01030, Mexico

Location

Unknown Facility

Mexico City, 01090, Mexico

Location

Unknown Facility

Mexico City, 02990, Mexico

Location

MeSH Terms

Interventions

trimegestone

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

  • Trial Manager

    For Mexico, gomezlj@wyeth.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

February 1, 2005

Study Completion

March 1, 2007

Last Updated

December 20, 2007

Record last verified: 2007-12

Locations

ME(6)