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Pharmacogenetic Study of Different Hormone Therapies in Recent Menopause Women

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ClinicalTrials.gov Identifier: NCT01432028
Recruitment Status : Completed
First Posted : September 12, 2011
Last Update Posted : January 27, 2014
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

Tracking Information
First Submitted Date  ICMJE April 19, 2011
First Posted Date  ICMJE September 12, 2011
Last Update Posted Date January 27, 2014
Study Start Date  ICMJE March 2007
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01432028 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2011)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 23, 2014)
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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacogenetic Study of Different Hormone Therapies in Recent Menopause Women
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Postmenopause
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: Estradiol and Progesterone
  • Active Comparator: oral homone therapy
    estradiol 1mg and drospirenone 2 mg/day
    Intervention: Drug: Estradiol and Drospirenone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2011)
90
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 42 Years to 58 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01432028
Other Study ID Numbers  ICMJE 05053
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Denusa Wiltgen, Federal University of Rio Grande do Sul
Study Sponsor  ICMJE Denusa Wiltgen
Collaborators  ICMJE
  • Hospital de Clinicas de Porto Alegre
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators  ICMJE
Study Director: Poli Mara Spritzer, MD, PhD Federal University of Rio Grande do Sul
PRS Account Federal University of Rio Grande do Sul
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP