Pharmacogenetic Study of Different Hormone Therapies in Recent Menopause Women

Postmenopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01432028
• Other study ID #: 05053
• Status: Completed
• Phase: N/A
• First received: April 19, 2011
• Last updated: January 23, 2014
• Start date: March 2007
• Est. completion date: April 2011

Study information

• Verified date: January 2014
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 42 Years to 58 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postmenopause

Intervention

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
• Estradiol and Drospirenone
oral estradiol 1mg and drospirenone 2 mg/day

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (4)

Lead Sponsor	Collaborator
Denusa Wiltgen	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effects of hormone therapy on C reactive protein, atrial natriuretic peptide and cardiovascular risk factors in postmenopause.	To assess the effects of oral low-dose and non-oral hormone therapy (HT) on ultra-sensitive C reactive protein (CRP), atrial natriuretic peptide (ANP), and cardiovascular risk factors in postmenopause.	Six months	No
Primary	Polymorphisms of estrogen receptor	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.	six months	No
Secondary	Polymorphisms in the fat mass-and obesity-associated (FTO) gene	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.	Six Months	No