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| Name | Class |
|---|---|
| Hospital de Clinicas de Porto Alegre | OTHER |
| Coordenação de Aperfeiçoamento de Pessoal de NÃvel Superior. | OTHER_GOV |
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-oral hormone therapy | Active Comparator | 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 | Active Comparator | estradiol 1mg and drospirenone 2 mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estradiol and Progesterone | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Polymorphisms of estrogen receptor | 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. | six months |
| Measure | Description | Time Frame |
|---|---|---|
| Polymorphisms in the fat mass-and obesity-associated (FTO) gene | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of hormone therapy on C reactive protein, atrial natriuretic peptide and cardiovascular risk factors in postmenopause. | 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. | Six months |
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Poli Mara Spritzer, MD, PhD | Federal University of Rio Grande do Sul | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25017924 | Derived | 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. | |
| 23046709 | Derived | 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. |
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| ID | Term |
|---|---|
| D004958 | Estradiol |
| D011374 | Progesterone |
| C035144 | drospirenone |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Estradiol and Drospirenone | Drug | oral estradiol 1mg and drospirenone 2 mg/day |
|
| Six Months |
| 22901973 | Derived | 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. |
| D011083 |
| Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D003339 | Corpus Luteum Hormones |
| D045167 | Progesterone Congeners |