Pharmacogenetic Study of Different Hormone Therapies in Recent Menopause Women

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01432028

Enrollment

Registered

2011-09-12

Start date

2007-03-31

Completion date

2011-04-30

Last updated

2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopause

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

Interventions

DRUGEstradiol 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

DRUGEstradiol and Drospirenone

oral estradiol 1mg and drospirenone 2 mg/day

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

42 Years to 58 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Polymorphisms of estrogen receptor	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.

Secondary

Measure	Time frame	Description
Polymorphisms in the fat mass-and obesity-associated (FTO) gene	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.

Other

Measure	Time frame	Description
Effects of hormone therapy on C reactive protein, atrial natriuretic peptide and cardiovascular risk factors in postmenopause.	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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026