Study Evaluating Estradiol/Trimegestone in Vasomotor Symptoms (VMS) in Post-Menopausal Women.
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postmenopause
Intervention: Trimegestone (Drug); 17b Estradiol (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Trial Manager, Principal Investigator, Affiliation: For Mexico, gomezlj@wyeth.com
Summary
The purpose of this study is to evaluate vasomotor symptoms (VMS) control of the continuous
regimen 17 b estradiol/trimegestone combination.
Clinical Details
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
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: To assess vasomotor symptoms control with a continuous regimen of 17 b estradiol 1mg and Trimegestone (TMG) 0.125 mg.
Secondary outcome: Study bleeding patterns throughout the treatment period (6 months)Evaluate changes in the Menopause-Specific Quality of Life Questionnaire
Eligibility
Minimum age: 45 Years.
Maximum age: 55 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Mexico City 01030, Mexico
Mexico City 01090, Mexico
Mexico City 02990, Mexico
Guadalajara, Jal. 44340, Mexico
Monterrey, N.L. 64000, Mexico
Monterrey, N.L. 64460, Mexico
Additional Information
Starting date: February 2005
Ending date: March 2007
Last updated: December 17, 2007
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