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Nanoparticulate Versus Micronized Steroids Delivery for Transdermal Hormone Replacement Therapy

NCT02467673 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2016-05-24

No results posted yet for this study

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.

Conditions

  • Menopausal Syndrome

Interventions

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.

Sponsors & Collaborators

  • InBios International, Inc.

    collaborator INDUSTRY

  • Federal University of São Paulo

    collaborator OTHER

  • University Potiguar

    lead OTHER

Principal Investigators

  • Ivaldo Silva, PHD · Federal University of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
42 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-03-31
Completion
2012-07-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02467673 on ClinicalTrials.gov