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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03149419
Recruitment Status : Completed
First Posted : May 11, 2017
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ciciliana Maíla Zilio Rech, Rio de Janeiro State University

Brief 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.

Condition or disease Intervention/treatment Phase
Postmenopausal Flushing Cardiovascular Risk Factor Endothelial Dysfunction Drug: Paroxetine Drug: Placebo oral capsule Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Endothelial, Autonomic and Pressure Effects of Paroxetine in Recent Postmenopause Women With Hot Flashes: a Randomized Placebo Controlled Clinical Trial
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : March 30, 2018


Arm Intervention/treatment
Active Comparator: Paroxetine
Paroxetine 7,5 mg - 1 pill/day for 12 weeks
Drug: Paroxetine
Placebo Comparator: Placebo
Placebo oral capsule (corn starch) - 1 pill/day for 12 weeks
Drug: Placebo oral capsule



Primary Outcome Measures :
  1. Endothelial function in non invasive venous occlusion plethysmography [ Time Frame: 12 weeks ]
    Forearm blood flow (ml/min per 100 ml)



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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. > 10 years of hypoestrogenism
  2. Smoking
  3. Diabetes mellitus or altered fasting glycemia in use of oral hypoglycemic agents or insulin
  4. BMI ≥ 35 Kg / m2
  5. Uncontrolled hypertension - blood pressure (BP) ≥ 140/90 mmHg
  6. 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;
  7. Uncompensated hypo or hyperthyroidism;
  8. Previous cardiovascular event history.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149419


Locations
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Brazil
Universidade do Estado do Rio de Janeiro
Rio de Janeiro, Brazil, 20550-900
Sponsors and Collaborators
Rio de Janeiro State University
Investigators
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Principal Investigator: Ciciliana MZ Rech Universidade do Estado do Rio de Janeiro- BioVasc laboratory
Study Chair: Ruth Clapauch, PhD Rio de Janeiro State University
Publications:
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Responsible Party: Ciciliana Maíla Zilio Rech, Principal Investigator, Rio de Janeiro State University
ClinicalTrials.gov Identifier: NCT03149419    
Other Study ID Numbers: CAAE 6717515.1.0000.5259
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ciciliana Maíla Zilio Rech, Rio de Janeiro State University:
postmenopause
paroxetine
endothelial dysfunction
blood pressure
heart rate variability
sleep quality
perceived stress
sleepiness
Additional relevant MeSH terms:
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Hot Flashes
Flushing
Signs and Symptoms
Skin Manifestations
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors