Study Comparing 17B Estradiol/TMG CC 1mg Vs. Tibolone In Postmenopausal Women
Phase 4
Completed
- Conditions
- Vasomotor Symptoms
- Interventions
- Drug: 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle)
- Registration Number
- NCT00472004
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 204
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle) 17B Estradiol (1mg) / (0.125 mg) Trimegestone (TMG) Continuous combined, 1 Daily, 1 year duration 2 Tibolone (Livial) Tibolone 2.5 mg 1 daily, 1 year duration
- Primary Outcome Measures
Name Time Method Decreased of Vasomotor Symptoms [from baseline to six and twelve months] 1 year
- Secondary Outcome Measures
Name Time Method Changes in Body Weight (from baseline to six and twelve months) 1 year Quality of Life (from baseline to six and twelve months) 1 year Treatment Adherence (from baseline to six and twelve months) 1 year Breast Tenderness (from baseline to six and twelve months) 1 year
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇲🇽Monterrey, Nuevo Leon, Mexico