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

• Status: Completed
• Trial end date: 2018-03-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rio de Janeiro State University
• Treatments: Paroxetine

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.