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”

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).

Study Type: Interventional

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

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• Drug: Intervention 1 Arm 1: 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined
  • 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined, 1 Daily, 1 year duration
• Drug: Tibolone
  • Tibolone 2.5 mg 1 daily, 1 year duration

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined, 1 Daily, 1 year duration
• Active Comparator: 2
  • Tibolone 2.5 mg 1 daily, 1 year duration

Primary Measures

• Evaluate the efficacy of Totelle and Tibolone in controlling the vasomotor symptoms and cycle control
  • Time Frame: 1 year
    Safety Issue?: No

Secondary 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
    Safety Issue?: Yes

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 Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Wyeth

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth  

Overall Contact: Trial Manager  clintrialparticipation@wyeth.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00472004

Study ID Number: 0753T-101800

ClinicalTrials.gov Identifier: NCT00472004

Health Authority: Mexico: Federal Commission for Protection Against Health Risks