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Hot Flash as a Marker of Cardiovascular Risk in Recent Postmenopause: Effects of Non-hormonal Treatments

NCT03149419 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2018-04-12

No results posted yet for this study

Summary

Hot flashes, vasomotor symptoms that affect many postmenopausal women, are associated with cardiovascular disease and endothelial dysfunction. Estrogen therapy, associated or not with progestogens, is the standard treatment for vasomotor symptoms and improves the endothelial function of postmenopausal women with hot flushes, even those with cardiovascular risk factors, such as hypertension. It is not known whether hot flushes are a cause for the development of endothelial dysfunction or are markers of this dysfunction, evidenced by estrogen deficiency, thus representing primitive target organ (vessel) lesion. Paroxetine was approved by the FDA as a non hormonal treatment for menopausal hot flashes. In this double-blind randomized clinical trial, the vascular effects of paroxetine at a dose of 7.5 mg / day, compared to placebo, during 12 weeks are evaluated.

Conditions

  • Postmenopausal Flushing
  • Cardiovascular Risk Factor
  • Endothelial Dysfunction

Interventions

DRUG

Paroxetine

DRUG

Placebo oral capsule

Sponsors & Collaborators

  • Rio de Janeiro State University

    lead OTHER

Principal Investigators

  • Ciciliana MZ Rech · Universidade do Estado do Rio de Janeiro- BioVasc laboratory

  • Ruth Clapauch, PhD · Rio de Janeiro State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-01
Primary Completion
2017-09-30
Completion
2018-03-30

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 NCT03149419 on ClinicalTrials.gov