None listed
Conditions
Interventions
Medroxyprogesterone Type of group
Medroxyprogesterone 2.5 mg / day + Equine conjugated estrogens 0.625 mg / day orally for 12 months.
Group name:Raloxifen Type of group
Raloxifene 60 mg / day will be taken orally once a day for 12 months
Sponsors
ELI LILLY INTERAMERICA INC.,
Eligibility
Inclusion criteria
Inclusion criteria: • Postmenopausal, ambulatory women, 60 years of age or older, with an intact uterus. • Those women who have presented their last menstruation at least 5 years prior to the start of the study. • Women with BMD measurements of lumbar spine or hip one or more standard deviations below the peak of bone mass in healthy premenopausal women (T-score <-1). • Women who agree to receive any of the two study therapies (Raloxifene or HRT). • Women who are free from severe conditions and • Incapacitants who are expected to remain ambulatory throughout the study and return to their follow-up visits. • Women who do not have language barriers, are cooperative, and who are willing to sign the Consent Report before entering the study.
Exclusion criteria
Exclusion criteria: • Women with the contraindication to receive any of the two study therapies, according to the information to prescribe Raloxifene or HTR. • Women who experience postmenopausal symptoms at the beginning of the study of sufficient severity requiring ERT. • Women where there is suspicion, is known, or has a history of breast carcinoma or an estrogen-dependent neoplasia. • Women with any abnormality or clinically significant endometrial or ovarian pathology, as determined by the primary investigator, through pelvic TVU. Uterine atrophy at this age is not considered an abnormality of UUT. • Women with any questionable or clinically relevant finding in the breast (including mammography) or in the pelvic exam (including pap smear) that requires greater clinical clarification. • Women with any history of malignancy within the • 5 years previous, except for superficial lesions removed such as basal or squamous cell carcinoma of the skin. • Women with a history of deep vein thrombosis, thromboembolic disorders (including transient ischemia), or stroke. • Women who have received treatment in the previous 2 months, or who have been treated for a period greater than 1 month in the last 6 months, with any of the following medications: Estrogens, Antiestrogens, Progestin, Androgens, Tamoxifen, Tibolone, others SERMs, including Raloxifene. • Women with clinically significant hypo or hyperthyroidism, as determined by the principal investigator. • Women with clinically significant acute or chronic liver disease, as determined by the investigator. • Women who, as determined by the investigator, have medical or psychiatric risks to receive treatment with the research drug. • Women who have participated in any clinical trial in the previous 28 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Kaplan-Meier survival curves for the start time of mammary sensitivity. Mammogram and breast exam. Measure:Start time of breast sensitivity Timepoints:First and last day of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of adverse events requested Measure:Incidence of adverse events requested associated with Raloxifene and / or the ccHRT Timepoints:Every day the treatment lasts ; Outcome name:Specific Questionnaire on Quality of Life During Menopause (MENQOL) Measure:Impact on the quality of life related to health Timepoints:In the first month, then in the months 6 and 12 ; Outcome name:Vaginal ultrasound Measure:Effect on endometrial thickness Timepoints:Before starting treatment and at 12 months ; Outcome name:Mammography with rating system Measure:Effect on mammary density Timepoints: Before starting treatment and at 12 months | — |
Outcome results
None listed