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| Name | Class |
|---|---|
| InBios International, Inc. | INDUSTRY |
| Federal University of São Paulo | OTHER |
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The study aims to asses the effects of micronized (MIC) and nanoparticulate (NANO) transdermal hormone therapy (THT) on blood pressure, ultra-sensitive C-reactive protein (CRP), and cardiovascular risk factors in postmenopausal women.
In this open label study, 27 postmenopausal women, with no clinical evidence of cardiovascular disease, were randomly divided in two groups.
During 12 weeks,
15 patients received on the left forearm micronized (MIC) THT (micronized 17β-estradiol 2.5 mg/day + progesterone 100 mg/day).
and
14 patients received a nanoparticulate (NANO) THT (nanoparticulate 17β-estradiol 2.5 mg/day + progesterone 100mg/day).
After 12 weeks of treatment patients were evaluated.
Baseline and Post-THT measures were determined: Insulin, body mass index, waist circumference, blood pressure, CRP-stratified levels, total testosterone, TSH and FSH levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NANOPARTICULATE estradiol+ progesterone | Active Comparator | The Blood samples are collected from the subjects early in the morning after an overnight fast. After serum testing, the identification hormone deficiencies, was determined and then, if necessary, additional transdermal nanostructured estradiol and progesterone is prescribed. The patients are evaluated 3 months after THRT treatment protocol. All the patients were instructed about how to use the pump for transdermal application, the first application is performed in the presence of an experienced physician, in order to guarantee standardization and correct use of the THRT. Compliance was defined as completing seventy percent or more of the transdermal applications. |
|
| MICRONIZED estradiol+ progesterone | Active Comparator | The Blood samples are collected from the subjects early in the morning after an overnight fast. After serum testing, the identification hormone deficiencies, was determined and then, if necessary, additional transdermal micronized estradiol and progesterone is prescribed. The patients are evaluated 3 months after THRT treatment protocol. All the patients were instructed about how to use the pump for transdermal application, the first application is performed in the presence of an experienced physician, in order to guarantee standardization and correct use of the THRT. Compliance was defined as completing seventy percent or more of the transdermal applications. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micronized estradiol + progesterone | Drug | Administration of micronized estradiol + progesterone daily by a metered-dose pump during 12 weeks in postmenopausal women with no clinical evidence of cardiovascular disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure variation | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| C-reactive protein levels after treatment | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivaldo Silva, PHD | Federal University of São Paulo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynelogical Center | Fortaleza | Ceará | 60115-191 | Brazil | ||
| University Potiguar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20835566 | Background | Botelho MA, Martins JG, Ruela RS, Queiroz DB, Ruela WS. Nanotechnology in ligature-induced periodontitis: protective effect of a doxycycline gel with nanoparticules. J Appl Oral Sci. 2010 Jul-Aug;18(4):335-42. doi: 10.1590/s1678-77572010000400003. | |
| 24519196 | Result | Botelho MA, Queiroz DB, Barros G, Guerreiro S, Fechine P, Umbelino S, Lyra A, Borges B, Freitas A, Queiroz DC, Ruela R, Almeida JG, Quintans L Jr. Nanostructured transdermal hormone replacement therapy for relieving menopausal symptoms: a confocal Raman spectroscopy study. Clinics (Sao Paulo). 2014 Feb;69(2):75-82. doi: 10.6061/clinics/2014(02)01. |
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| ID | Term |
|---|---|
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Nanoparticulate estradiol + progesterone | Drug | Administration of nanoparticulate estradiol + progesterone daily by a metered-dose pump during 12 weeks in postmenopausal women with no clinical evidence of cardiovascular disease. |
|
|
| Natal |
| Rio Grande do Norte |
| 59060 |
| Brazil |
| Marco Botelho | São Paulo | São Paulo | 04023-062 | Brazil |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |