Overview

Pharmacogenetic Study of Different Hormone Therapies in Recent Menopause Women

Status:
Completed
Trial end date:
2011-04-01
Target enrollment:
0
Participant gender:
Female
Summary
This is cross-over, randomized clinical trial, with objective to evaluate the effects of low-dose oral hormone therapy and non-oral hormone therapy on endothelial function markers (fibrinogen, von Willebrand factor, c-reactive protein), natriuretic peptide and on anthropometric, metabolic and hormonal variables in early and healthy postmenopausal women and analyzing polymorphisms in the estrogen receptor gene and FTO polymorphisms Patients will be randomized to receive oral hormone treatment or non-oral hormone treatment The investigators hypothesis is that a different genotypes in the receptor estrogen gene and FTO may have an influences on treatment response in metabolic markers and cardiovascular risk
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Denusa Wiltgen
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Hospital de Clinicas de Porto Alegre
Treatments:
Drospirenone
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Hormones
Polyestradiol phosphate
Progesterone
Criteria
Inclusion criteria:

- last menstrual period between 6 months and 3 years before the beginning of the study
plus FSH levels higher than 35 IU/L;

- age between 42 and 58 years;

- no use of any medication known to interfere with hormonal, glucose, or lipoprotein
levels in the past 3 months;

- no use of steroidal or no steroidal anti-inflammatory drugs in the last 15 days.

Exclusion criteria:

- patients with diabetes,

- previous hysterectomy,

- endometrial thickness >0.5cm,

- history of cancer,

- thromboembolism, or

- established cardiovascular disease