Micronized estradiol + progesterone
DrugAdministration of micronized estradiol + progesterone daily by a metered-dose pump during 12 weeks in postmenopausal women with no clinical evidence of cardiovascular disease.
Other names: Mic Group
NCT Number: NCT02467673
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.
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Notify Me42 year–75 year
Female
Interventional
Phase 2
Gynelogical Center, Fortaleza, Ceará, Brazil
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administration of micronized estradiol + progesterone daily by a metered-dose pump during 12 weeks in postmenopausal women with no clinical evidence of cardiovascular disease.
Other names: Mic Group
Administration of nanoparticulate estradiol + progesterone daily by a metered-dose pump during 12 weeks in postmenopausal women with no clinical evidence of cardiovascular disease.
Other names: NANO Group
Time frame: 12 weeks
Time frame: 12 weeks
University Potiguar
Other
Nanoparticulate Versus Micronized Steroids Delivery for Transdermal Hormone Replacement Therapy: Effects on Blood Pressure, Insulin and C-reactive Protein and in Postmenopausal Women
Acronym: Nanoparticle
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