Pharmacogenetic Study of Different Hormone Therapies in Recent Menopause Women

Denusa Wiltgen

Status: Completed

Conditions: Postmenopause

Treatments: Drug: Estradiol and Drospirenone; Drug: Estradiol and Progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT01432028

05053

Details and patient eligibility

About

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

Enrollment: 90 patients

Sex: Female

Ages: 42 to 58 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Non-oral hormone therapy

Active Comparator group

Description:

3 mg/day intranasal estradiol daily or 1,5 mg/day transdermal estradiol and 200 mg/day vaginal micronized progesterone for 14 days/month

Treatment:

Drug: Estradiol and Progesterone

oral homone therapy

Active Comparator group

Description:

estradiol 1mg and drospirenone 2 mg/day

Treatment:

Drug: Estradiol and Drospirenone