Effects of Hormone Replacement Therapy on Cardiovascular Risk and Body Composition Parameters

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

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 associated with increased levels of FSH and low levels of estradiol. The decline in estrogenic levels is associated with several organic changes, from vasomotor symptoms to impaired bone mass and urogenital atrophy. Although for some patients menopause is asymptomatic or oligosymptomatic, many women experience intense symptoms, which profoundly affect quality of life.

Proper assessment and treatment of postmenopausal women can significantly improve climacteric symptoms. Target tissue, hormone therapy regimen and variations between patients will influence the effects of treatment. Regarding estrogen, the main factors that influence the therapeutic response are the type of hormone used, the dose and the route of administration. The skin metabolizes only a small part of estradiol. Thus, the transdermal route reaches adequate therapeutic levels from a lower dose of estrogen.

The present study aims to evaluate and compare the effects of low dose of oral estradiol associated with oral progesterone and transdermal estradiol associated with vaginal progesterone on variables related to inflammation, coagulation and body composition parameters.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospital de Clinicas de Porto Alegre
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Hormones; Polyestradiol phosphate; Progesterone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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).