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Completed

NCT Number: NCT01432028

Pharmacogenetic Study of Different Hormone Therapies in Recent Menopause Women

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

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Key information

Conditions

Postmenopause

Age range

42 year–58 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Estradiol and Progesterone

Drug

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

Drug

oral estradiol 1mg and drospirenone 2 mg/day

Primary outcomes

  1. Polymorphisms of estrogen receptor

    Time frame: 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 outcomes

  1. Polymorphisms in the fat mass-and obesity-associated (FTO) gene

    Time frame: 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.

Other outcomes

  1. Effects of hormone therapy on C reactive protein, atrial natriuretic peptide and cardiovascular risk factors in postmenopause.

    Time frame: Six months

    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.

Sponsors and collaborators

Lead sponsor

Denusa Wiltgen

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Hospital de Clinicas de Porto Alegre

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Sep 12, 2011
Registry last updated
Jan 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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