Study Comparing 17B Estradiol/TMG CC 1mg vs. Tibolone in Postmenopausal Women - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

May 8, 2007

Last Updated Date

December 21, 2007

Start Date ^†

February 2006

Current Primary Outcome Measures ^†

Evaluate the efficacy of Totelle and Tibolone in controlling the vasomotor symptoms and cycle control [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00472004 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Evaluate the effects of Totelle and Tibolone on tolerability profile defined as: weight changes, breast tenderness; Quality of Life and Adherence to Treatment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Study Comparing 17B Estradiol/TMG CC 1mg vs. Tibolone in Postmenopausal Women

Official Title ^†

A Prospective, Randomised, Open Label Study to Compare the Efficacy, Safety and Tolerability of 17B Estradiol/TMG CC 1mg and Tibolone in Postmenopausal Women

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).

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Vasomotor Symptoms

Intervention ^†

Drug: Intervention 1 Arm 1: 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined
Drug: Tibolone

Study Arms / Comparison Groups

Active Comparator: 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined, 1 Daily, 1 year duration
Active Comparator: Tibolone 2.5 mg 1 daily, 1 year duration

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

200

Estimated Completion Date

December 2008

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

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

Gender

Female

Ages

45 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Trial Manager

clintrialparticipation@wyeth.com

Location Countries ^†

Mexico

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00472004

Responsible Party

Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth

Secondary IDs ^††

Study Sponsor ^†

Wyeth

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor

Wyeth

Information Provided By

Wyeth

Verification Date

December 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.