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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02467673

Acronym

Nanoparticle

Enrollment

185

Registered

2015-06-10

Start date

2012-01-31

Completion date

2012-07-31

Last updated

2016-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopausal Syndrome

Brief 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.

Interventions

DRUGMicronized 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.

DRUGNanoparticulate 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

42 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

* A body mass index between 18 and 27 kg/m2; * Sex live complaints; * No evidence of cardiovascular disease; * General good health based on history and physical examination.

Exclusion criteria

* A past history of neurological disorder; * Had received pharmacotherapy for cardiovascular disease before screening * Taking medication known to interfere with steroids; * Recent psychiatric or systemic illness; * Uncontrolled hypertension (blood pressure\>160/95mmHg), * Unstable cardiovascular disease; * Genital bleeding; * Use of psychoactive medications, * Alcohol excess consumption or any other drug abuse;

Design outcomes

Primary

Measure	Time frame
Blood Pressure variation	12 weeks

Secondary

Measure	Time frame
C-reactive protein levels after treatment	12 weeks

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026