NCT02467673

Nanoparticulate Versus Micronized Steroids Delivery for Transdermal Hormone Replacement Therapy

Nanoparticulate Versus Micronized Steroids Delivery for Transdermal Hormone Replacement Therapy: Effects on Blood Pressure, Insulin and C-reactive Protein and in Postmenopausal Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: University Potiguar · Academic / Other
• Sex: Female
• Age: 42 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Menopausal Syndrome

Interventions

Type	Name	Description
DRUG	Micronized estradiol + progesterone	Administration of micronized estradiol + progesterone daily by a metered-dose pump during 12 weeks in postmenopausal women with no clinical evidence of cardiovascular disease.
DRUG	Nanoparticulate estradiol + progesterone	Administration of nanoparticulate estradiol + progesterone daily by a metered-dose pump during 12 weeks in postmenopausal women with no clinical evidence of cardiovascular disease.

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-03-01
• Completion: 2012-07-01
• First posted: 2015-06-10
• Last updated: 2016-05-24

Locations

3 sites across 1 country: Brazil