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Pharmacogenetic Study of Different Hormone Therapies in Recent Menopause Women

NCT01432028 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2014-01-27

No results posted yet for this study

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

Conditions

  • Postmenopause

Interventions

DRUG

Estradiol and Progesterone

3 mg/day intranasal estradiol daily or 1,5 mg/day transdermal estradiol and 200 mg/day vaginal micronized progesterone for 14 days/month

DRUG

Estradiol and Drospirenone

oral estradiol 1mg and drospirenone 2 mg/day

Sponsors & Collaborators

  • Hospital de Clinicas de Porto Alegre

    collaborator OTHER

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

    collaborator OTHER_GOV

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • Denusa Wiltgen

    lead OTHER

Principal Investigators

  • Poli Mara Spritzer, MD, PhD · Federal University of Rio Grande do Sul

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
42 Years
Max Age
58 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01432028 on ClinicalTrials.gov