Vasomotor Symptoms
Conditions
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).
Interventions
DRUG17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle)
17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined, 1 Daily, 1 year duration
DRUGTibolone (Livial)
Tibolone 2.5 mg 1 daily, 1 year duration
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 55 Years
Healthy volunteers
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decreased of Vasomotor Symptoms [from baseline to six and twelve months] | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Mexico
Outcome results
None listed