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

Phase 4

Completed

• Conditions: Postmenopausal Flushing; Endothelial Dysfunction; Cardiovascular Risk Factor
• Interventions: Drug: Placebo oral capsule; Drug: Paroxetine

• Registration Number: NCT03149419
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2017-04-18
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-11
• Primary Completion: 2017-09-30
• Study Completion: 2018-03-30
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo oral capsule	Placebo oral capsule (corn starch) - 1 pill/day for 12 weeks
Paroxetine	Paroxetine	Paroxetine 7,5 mg - 1 pill/day for 12 weeks

Primary Outcome Measures

Name	Time	Method
Endothelial function in non invasive venous occlusion plethysmography	12 weeks	Forearm blood flow (ml/min per 100 ml)

Trial Locations

Locations (1)

Universidade do Estado do Rio de Janeiro; 🇧🇷 Rio de Janeiro, Brazil