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

Tracking Information

First Received Date ^ICMJE

May 8, 2007

Last Updated Date

July 8, 2009

Start Date ^ICMJE

February 2006

Estimated Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

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 ^ICMJE

Evaluate the efficacy of Totelle and Tibolone in controlling the vasomotor symptoms and cycle control

Change History

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

Current Secondary Outcome Measures ^ICMJE

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 ^ICMJE

Evaluate the effects of Totelle and Tibolone on tolerability profile defined as: weight changes, breast tenderness; Quality of Life and Adherence to Treatment

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Vasomotor Symptoms

Intervention ^ICMJE

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 ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

December 2008

Estimated Primary Completion Date

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

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Mexico

Administrative Information

NCT ID ^ICMJE

NCT00472004

Responsible Party

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

Study ID Numbers ^ICMJE

0753T-101800

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth

Information Provided By

Wyeth

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP