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Nanoparticulate Versus Micronized Steroids Delivery for Transdermal Hormone Replacement Therapy

Information source: University Potiguar
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Menopausal Syndrome

Intervention: Micronized estradiol + progesterone (Drug); Nanoparticulate estradiol + progesterone (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University Potiguar

Official(s) and/or principal investigator(s):
Ivaldo Silva, PHD, Study Director, Affiliation: Federal University of São Paulo

Overall contact:
MARCO A BOTELHO, PhD, Phone: +558586685000, Email: marcobotelho1@gmail.com


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Blood Pressure variation

Secondary outcome: C-reactive protein levels after treatment

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.


Minimum age: 42 Years. Maximum age: 75 Years. Gender(s): Female.


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;

Locations and Contacts

MARCO A BOTELHO, PhD, Phone: +558586685000, Email: marcobotelho1@gmail.com

Marco Botelho, Sao Paulo 04023-062, Brazil; Recruiting
Ivaldo Silva, PhD, Phone: +551155764718, Email: ivaldosilva@gmail.com
Phone: +558586685000, Email: marcobotelho1@gmail.com
Dinalva B Queiroz, PhD, Sub-Investigator
Ivaldo Silva, PhD, Principal Investigator

Gynelogical Center, Fortaleza, CE 60115-191, Brazil; Recruiting
Marco A Botelho, PhD, Phone: ++558586685000, Email: marcobotelho1@gmail.com
Dinalva B Queiroz, MSc, Phone: ++558588864388, Email: dinafarma@gmail.com
Marco A Botelho, MSC, PhD, Principal Investigator

University Potiguar, Natal, RN 59060, Brazil; Completed

Additional Information

Related publications:

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.

Starting date: August 2012
Last updated: June 9, 2015

Page last updated: August 23, 2015

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