Pharmacogenetic Study of Different Hormone Therapies in Recent Menopause Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2011-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Postmenopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Estradiol and Progesterone

Intervention Type 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

oral homone therapy

estradiol 1mg and drospirenone 2 mg/day

Group Type ACTIVE_COMPARATOR

Estradiol and Drospirenone

Intervention Type DRUG

oral estradiol 1mg and drospirenone 2 mg/day

Interventions

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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

Intervention Type DRUG

Estradiol and Drospirenone

oral estradiol 1mg and drospirenone 2 mg/day

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

42 Years

Maximum Eligible Age

58 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes