Pharmacogenetic Study of Different Hormone Therapies in Recent Menopause Women

Not Applicable

Completed

• Conditions: Postmenopause
• Interventions: Drug: Estradiol and Progesterone; Drug: Estradiol and Drospirenone

• Registration Number: NCT01432028
• Lead Sponsor: Denusa Wiltgen

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Study First Submitted: 2011-04-19
• Study First Submitted QC: 2011-09-09
• Study First Posted: 2011-09-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-23
• Last Update Posted: 2014-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Non-oral hormone therapy	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
oral homone therapy	Estradiol and Drospirenone	estradiol 1mg and drospirenone 2 mg/day

Primary Outcome Measures

Name	Time	Method
Polymorphisms of estrogen receptor	six months	Influence of 4 polymorphisms (PVUII, ALUI, RSAI and BSTUI) on the effect of different treatment regimens. Change from Baseline in weight, waist circumference, BMI, systolic and diastolic blood pressure, fasting glucose, glucose at 120 min, Fasting insulin, HOMA, Cholesterol, HDL-c, LDL-c, Triglycerides, Von Willebrand Factor, Fibrinogen, Testosterone and C-reactive protein at six months.

Secondary Outcome Measures

Name	Time	Method
Polymorphisms in the fat mass-and obesity-associated (FTO) gene	Six Months	Influence of 2 polymorphisms (rs9939609 and rs8050136) on the effect of different treatment regimens. Change from Baseline in weight, waist circumference, BMI, systolic and diastolic blood pressure, fasting glucose, glucose at 120 min, Fasting insulin,HOMA, Cholesterol, HDL-c, LDL-c, Triglycerides, Von Willebrand Factor, Fibrinogen, Testosterone and C-reactive protein at six months.

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil