NCT00195455
Completed
Phase 4
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
Wyeth is now a wholly owned subsidiary of Pfizer0 sites133 target enrollmentFebruary 2005
ConditionsPostmenopause
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Postmenopause
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Enrollment
- 133
- Primary Endpoint
- To assess vasomotor symptoms control with a continuous regimen of 17 b estradiol 1mg and Trimegestone (TMG) 0.125 mg.
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
The purpose of this study is to evaluate vasomotor symptoms (VMS) control of the continuous regimen 17 b estradiol/trimegestone combination.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
To assess vasomotor symptoms control with a continuous regimen of 17 b estradiol 1mg and Trimegestone (TMG) 0.125 mg.
Secondary Outcomes
- Study bleeding patterns throughout the treatment period (6 months)
- Evaluate changes in the Menopause-Specific Quality of Life Questionnaire
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