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NCT00195455 Clinical Trial

Study Evaluating Estradiol/Trimegestone in Vasomotor Symptoms (VMS) in Post-Menopausal Women.

Postmenopause Clinical Trial

Official title:
A Prospective Open Label Study to Evaluate Vasomotor Symptoms Control and Bleeding Patterns With a Continuous Regimen of a New Progestin Trimegestone 0.125 mg and 17 b Estradiol 1 mg (Totelle),as HT on Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00195455
Other study ID # 0753T-101538
Secondary ID
Status Completed
Phase Phase 4
First received September 12, 2005
Last updated December 17, 2007
Start date February 2005
Est. completion date March 2007

Study information
Verified date December 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority Mexico: Federal Commission for Protection Against Health Risks
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 133
Est. completion date March 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years to 55 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Known or suspected breast carcinoma or estrogen-dependent neoplasm

- Undiagnosed abnormal genital bleeding

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Trimegestone

• 17b Estradiol

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary To assess vasomotor symptoms control with a continuous regimen of 17 b estradiol 1mg and Trimegestone (TMG) 0.125 mg.
Secondary Study bleeding patterns throughout the treatment period (6 months)
Secondary Evaluate changes in the Menopause-Specific Quality of Life Questionnaire
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