A Prospective, Randomized, Open Label Study To Compare The Efficacy, Safety And Tolerability Of 17-B Estradiol/Trimegestone CC 1 Mg (Totelle) And Tibolone (Livial) In Postmenopausal Women.

Wyeth is now a wholly owned subsidiary of Pfizer1 site in 1 country204 target enrollmentFebruary 2006

ConditionsVasomotor Symptoms

Interventions17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle)Tibolone (Livial)

Drugs17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle)Tibolone (Livial)

Overview

Phase: Phase 4
Intervention: 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle)
Conditions: Vasomotor Symptoms
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 204
Locations: 1
Primary Endpoint: Decreased of Vasomotor Symptoms [from baseline to six and twelve months]
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase IV prospective, randomized, open label, comparative, multicenter study in generally healthy postmenopausal women receiving Totelle (17B Estradiol/TMG CC (1mg)) and Livial (Tibolone).

Registry

clinicaltrials.gov

Start Date

February 2006

End Date

December 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility Criteria

Inclusion Criteria

•Generally healthy postmenopausal women
•Last natural (without exogenous hormone therapy) menstrual cycle completed at least 12 consecutive months prior to screening and without any other kind of gynecological bleeding during this same period
•At least 1 year of natural occurring amenorrhea

Exclusion Criteria

•Known or suspected estrogen-dependent neoplasia
•Endometrial hyperplasia
•Any malignancy with the exception of a history of basal cell carcinoma of the skin