Status:
UNKNOWN
Effects of Hormone Replacement Therapy on Cardiovascular Risk and Body Composition Parameters
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Conditions:
Menopause
Hormone Replacement Therapy
Eligibility:
FEMALE
40-58 years
Phase:
NA
Brief Summary
Menopause is defined as the last episode of menstrual bleeding, resulting from the interruption of ovarian function by follicular depletion. It is characterized by the presence of amenorrhea associate...
Detailed Description
Hormone therapy (HT) was available since 1942 in tablets containing conjugated equine estrogens. Since the 1970s, it has been recommended to add progestogens to the treatment of women with a uterus to...
Eligibility Criteria
Inclusion
- Six months or more of amenorrhea and FSH levels\> or = at 35 mIU / ml;
- Menopause for a maximum of three years;
- Mammography and cytology of recent cervix (from the last 12 months);
- Signature of the Informed Consent Form.
Exclusion
- Menopause age below 40 years;
- Use of hormonal therapy in the three months preceding the study;
- Uncontrolled diabetes mellitus;
- Endometrial thickening (endometrial thickness greater than 0.5 cm);
- Neoplasm of breast, colon or endometrium;
- History of thromboembolism or established cardiovascular disease;
- Previous hysterectomy;
- Active smoking;
- Use of medication to treat osteoporosis in the last 12 months: bisphosphonates, denosumab, teriparatide, SERMs (selective estrogen receptor agonist).
Key Trial Info
Start Date :
October 9 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04453332
Start Date
October 9 2015
End Date
December 1 2021
Last Update
July 1 2020
Active Locations (1)
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1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035903