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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-01

Study Completion Date

2018-03-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Postmenopausal Flushing Cardiovascular Risk Factor Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Paroxetine

Paroxetine 7,5 mg - 1 pill/day for 12 weeks

Group Type ACTIVE_COMPARATOR

Paroxetine

Intervention Type DRUG

Placebo

Placebo oral capsule (corn starch) - 1 pill/day for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

Interventions

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Paroxetine

Intervention Type DRUG

Placebo oral capsule

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes