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