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: September 16, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

April 19, 2011

Last Updated Date

September 16, 2011

Start Date ^ICMJE

March 2007

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

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

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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 and on anthropometric, metabolic and hormonal variables in early and healthy postmenopausal women and analyzing polymorphisms in the estrogen receptor gene and metabolic variables with the FTO, anthropometric and endothelial function

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

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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 Arm (s)

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

Enrollment ^ICMJE

Completion Date

April 2011

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

Gender

Female

Ages

42 Years to 58 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT01432028

Other Study ID Numbers ^ICMJE

05053

Has Data Monitoring Committee

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

Information Provided By

Federal University of Rio Grande do Sul

Verification Date

September 2011

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

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