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

Vasomotor Symptoms Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00472004
• Other study ID #: 0753T-101800
• Secondary ID: B2481004
• Status: Completed
• Phase: Phase 4
• First received: May 8, 2007
• Last updated: October 28, 2010
• Start date: February 2006
• Est. completion date: December 2009

Study information

• Verified date: October 2010
• 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vasomotor Symptoms

Intervention

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
• Tibolone (Livial)
Tibolone 2.5 mg 1 daily, 1 year duration

Locations

Country	Name	City	State
Mexico	Pfizer Investigational Site	Monterrey	Nuevo Leon

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	Decreased of Vasomotor Symptoms [from baseline to six and twelve months]		1 year	No
Secondary	Changes in Body Weight (from baseline to six and twelve months)		1 year	Yes
Secondary	Quality of Life (from baseline to six and twelve months)		1 year	Yes
Secondary	Treatment Adherence (from baseline to six and twelve months)		1 year	Yes
Secondary	Breast Tenderness (from baseline to six and twelve months)		1 year	Yes

External Links

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