NCT01432028

Pharmacogenetic Study of Different Hormone Therapies in Recent Menopause Women

Polymorphisms in Genes Encoding the Estrogen Metabolism Enzymes and Effects of Hormone Therapy for Oral Low Dose or Not Oral on Variables Related Endothelial Function, Inflammation and Metabolic Profile in Patients in Recent Menopause Study Pharmacogenetic

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Denusa Wiltgen · Academic / Other
• Sex: Female
• Age: 42 Years – 58 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2007-03-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2011-09-12
• Last updated: 2014-01-27

Locations

1 site across 1 country: Brazil