Cardiovascular Risk Factor, Endothelial Dysfunction, Postmenopausal Flushing
Conditions
Keywords
postmenopause, paroxetine, endothelial dysfunction, blood pressure, heart rate variability, sleep quality, perceived stress, sleepiness
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.
Interventions
DRUGParoxetine
DRUGPlacebo oral capsule
Sponsors
Rio de Janeiro State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial function in non invasive venous occlusion plethysmography | 12 weeks | Forearm blood flow (ml/min per 100 ml) |
Countries
Brazil
Outcome results
None listed