Official Title: “A Prospective Open Label Study to Evaluate Vasomotor Symptoms Control and Bleeding Patterns With a Continuous Regimen of a New Progestin Trimegestone 0.125 mg and 17 b Estradiol 1 mg (Totelle),as HT on Postmenopausal Women”

The purpose of this study is to evaluate vasomotor symptoms (VMS) control of the continuous regimen 17 b estradiol/trimegestone combination.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Trimegestone
• Drug: 17b Estradiol

Primary Measures

• To assess vasomotor symptoms control with a continuous regimen of 17 b estradiol 1mg and Trimegestone (TMG) 0.125 mg.

Secondary Measures

• Study bleeding patterns throughout the treatment period (6 months)
• Evaluate changes in the Menopause-Specific Quality of Life Questionnaire

Inclusion Criteria:

• Generally healthy postmenopausal women 45 to 55 years of age inclusive, with at least 1 year of natural occurring amenorrhea, with vasomotor symptoms, with at least 4 hot flushes per day
• Intact uterus

Exclusion Criteria:

• Known or suspected breast carcinoma or estrogen-dependent neoplasm
• Undiagnosed abnormal genital bleeding

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  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00195455

Study ID Number: 0753T-101538

ClinicalTrials.gov Identifier: NCT00195455

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