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Completed

NCT Number: NCT03149419

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

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.

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Key information

Conditions

Postmenopausal Flushing Cardiovascular Risk Factor Dyssomnias Endothelial Dysfunction Mental Disorders Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Sleepiness

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Universidade do Estado do Rio de Janeiro

Rio de Janeiro, 20550-900, Brazil

About this study

Paroxetine and placebo effects at baseline and after 12 weeks in endothelial, autonomic and pressure components of vascular function are evaluated.

Non invasive venous occlusion plethysmography is used to study endothelial function; ambulatory blood pressure monitoring is used to study blood pressure variations during daytime and nocturnal descent; autonomic function is studied following sympathetic and parasympathetic parameters through heart rate variability.

The effects of paroxetine and placebo are also evaluated on:

  • daytime sleepiness (through Epworth Sleepiness Scale ),
  • sleep quality (through Pittsburgh Sleep Quality Index),
  • perceived stress (through Perceived Scale Stress).

Biochemical and hormonal profiles including complete lipid profile, fasting glucose, insulin, estradiol, follicle stimulating hormone (FSH), luteinizing hormone (LH); inflammatory and oxidative stress markers are also studied.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postmenopause
  • Present hot flushes (note ≥ 3 on a scale of 0 to 10)

Exclusion criteria

  • > 10 years of hypoestrogenism
  • Smoking
  • Diabetes mellitus or altered fasting glycemia in use of oral hypoglycemic agents or insulin
  • BMI ≥ 35 Kg / m2
  • Uncontrolled hypertension - blood pressure (BP) ≥ 140/90 mmHg
  • Users of glucocorticoids, phytoestrogens, β-blockers, selective serotonin reuptake inhibitors (SSRIs), selective noradrenaline reuptake inhibitors (SNRIs), clonidine, gabapentin, pregabalin, cinnarizine, alphamethyldopa or any drugs with effects on the central nervous system;
  • Uncompensated hypo or hyperthyroidism;
  • Previous cardiovascular event history.

Treatment and study plan

paroxetine

Drug

Placebo oral capsule

Drug

Primary outcomes

  1. Endothelial function in non invasive venous occlusion plethysmography

    Time frame: 12 weeks

    Forearm blood flow (ml/min per 100 ml)

Sponsors and collaborators

Lead sponsor

Rio de Janeiro State University

Other

Registry information

Official study title

Endothelial, Autonomic and Pressure Effects of Paroxetine in Recent Postmenopause Women With Hot Flashes: a Randomized Placebo Controlled Clinical Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
May 11, 2017
Registry last updated
Apr 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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