Pharmacogenetic Study of Different Hormone Therapies in Recent Menopause Women

This study has been completed.
Sponsor:
Collaborators:
Hospital de Clinicas de Porto Alegre
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Denusa Wiltgen, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT01432028
First received: April 19, 2011
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Postmenopause
Drug: Estradiol and Progesterone
Drug: Estradiol and Drospirenone

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

Resource links provided by NLM:


Further study details as provided by Federal University of Rio Grande do Sul:

Primary Outcome Measures:
  • Polymorphisms of estrogen receptor [ Time Frame: six months ] [ Designated as safety issue: No ]
    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:
  • Polymorphisms in the fat mass-and obesity-associated (FTO) gene [ Time Frame: Six Months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Effects of hormone therapy on C reactive protein, atrial natriuretic peptide and cardiovascular risk factors in postmenopause. [ Time Frame: Six months ] [ Designated as safety issue: No ]
    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.


Enrollment: 90
Study Start Date: March 2007
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Non-oral hormone therapy
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 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
Active Comparator: oral homone therapy
estradiol 1mg and drospirenone 2 mg/day
Drug: Estradiol and Drospirenone
oral estradiol 1mg and drospirenone 2 mg/day

  Eligibility

Ages Eligible for Study:   42 Years to 58 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432028

Locations
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Sponsors and Collaborators
Denusa Wiltgen
Hospital de Clinicas de Porto Alegre
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Study Director: Poli Mara Spritzer, MD, PhD Federal University of Rio Grande do Sul
  More Information

No publications provided by Federal University of Rio Grande do Sul

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Denusa Wiltgen, MD,PhD, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT01432028     History of Changes
Other Study ID Numbers: 05053
Study First Received: April 19, 2011
Last Updated: January 23, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Hormones
Progesterone
Drospirenone
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estrogens
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Progestins
Aldosterone Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on April 22, 2014