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Study Comparing 17B Estradiol/TMG CC 1mg Vs. Tibolone In Postmenopausal Women

NCT00472004 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2010-10-29

No results posted yet for this study

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).

Conditions

Interventions

DRUG

17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle)

17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined, 1 Daily, 1 year duration

DRUG

Tibolone (Livial)

Tibolone 2.5 mg 1 daily, 1 year duration

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00472004 on ClinicalTrials.gov