Clinical trial NCT01432028: Pharmacogenetic Study of Different Hormone Therapies in Recent Menopause Women
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postmenopause
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Hospital de Clinicas de Porto Alegre
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2011-09-12
Enrollment: 90
Sex: FEMALE
Minimum age (years): 42
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Polymorphisms of estrogen receptor
timeFrame: six months
Secondary outcomes:
measure: Polymorphisms in the fat mass-and obesity-associated (FTO) gene
timeFrame: Six Months
Other outcomes:
measure: Effects of hormone therapy on C reactive protein, atrial natriuretic peptide and cardiovascular risk factors in postmenopause.
timeFrame: Six months
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Poli Mara Spritzer, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Casanova G, dos Reis AM, Spritzer PM. Low-dose oral or non-oral hormone therapy: effects on C-reactive protein and atrial natriuretic peptide in menopause. Climacteric. 2015 Feb;18(1):86-93. doi: 10.3109/13697137.2014.940309. Epub 2014 Oct 21.
citation: Casanova G, Spritzer PM. Effects of micronized progesterone added to non-oral estradiol on lipids and cardiovascular risk factors in early postmenopause: a clinical trial. Lipids Health Dis. 2012 Oct 9;11:133. doi: 10.1186/1476-511X-11-133.
citation: Ramos RB, Casanova GK, Spritzer PM. Fat mass and obesity-associated gene polymorphisms do not affect metabolic response to hormone therapy in healthy postmenopausal women. Eur J Obstet Gynecol Reprod Biol. 2012 Dec;165(2):302-6. doi: 10.1016/j.ejogrb.2012.07.024. Epub 2012 Aug 15.