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CompletedNCT03149419Updated Apr 12, 2018

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

A Phase 4 interventional study of Paroxetine and Placebo oral capsule in Postmenopausal Flushing, Cardiovascular Risk Factor and Endothelial Dysfunction, sponsored by Rio de Janeiro State University. Completed at 1 site in Brazil. Open to female participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-12.

Sponsored by Rio de Janeiro State University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Postmenopausal Flushing
  • Cardiovascular Risk Factor
  • Endothelial Dysfunction

Keywords

  • postmenopause
  • paroxetine
  • endothelial dysfunction
  • blood pressure
  • heart rate variability
  • sleep quality
  • perceived stress
  • sleepiness
03

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
140 participants (actual)

Study arms

  • 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

Interventions

  • DrugParoxetine
  • DrugPlacebo oral capsule
05

What researchers measure

Primary outcomes

  1. Endothelial function in non invasive venous occlusion plethysmography

    Forearm blood flow (ml/min per 100 ml)

    Time frame: 12 weeks

06

Study locations

1 site
  • Universidade do Estado do Rio de Janeiro
    Rio de Janeiro, 20550-900, Brazil
07

References and documents

Publications

  • Taddei S, Virdis A, Ghiadoni L, Mattei P, Sudano I, Bernini G, Pinto S, Salvetti A. Menopause is associated with endothelial dysfunction in women. Hypertension. 1996 Oct;28(4):576-82. doi: 10.1161/01.hyp.28.4.576. PubMed 8843881 ↗
  • Bechlioulis A, Kalantaridou SN, Naka KK, Chatzikyriakidou A, Calis KA, Makrigiannakis A, Papanikolaou O, Kaponis A, Katsouras C, Georgiou I, Chrousos GP, Michalis LK. Endothelial function, but not carotid intima-media thickness, is affected early in menopause and is associated with severity of hot flushes. J Clin Endocrinol Metab. 2010 Mar;95(3):1199-206. doi: 10.1210/jc.2009-2262. Epub 2010 Jan 15. PubMed 20080857 ↗
  • Lambrinoudaki I, Augoulea A, Armeni E, Rizos D, Alexandrou A, Creatsa M, Kazani M, Georgiopoulos G, Livada A, Exarchakou A, Stamatelopoulos K. Menopausal symptoms are associated with subclinical atherosclerosis in healthy recently postmenopausal women. Climacteric. 2012 Aug;15(4):350-7. doi: 10.3109/13697137.2011.618564. Epub 2011 Dec 1. PubMed 22132748 ↗
  • Silveira JS, Clapauch R, Souza Md, Bouskela E. Hot flashes: emerging cardiovascular risk factors in recent and late postmenopause and their association with higher blood pressure. Menopause. 2016 Aug;23(8):846-55. doi: 10.1097/GME.0000000000000641. PubMed 27219834 ↗
  • Orleans RJ, Li L, Kim MJ, Guo J, Sobhan M, Soule L, Joffe HV. FDA approval of paroxetine for menopausal hot flushes. N Engl J Med. 2014 May 8;370(19):1777-9. doi: 10.1056/NEJMp1402080. No abstract available. PubMed 24806158 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03149419
Lead sponsor
Rio de Janeiro State University
Responsible party
Ciciliana Maíla Zilio Rech (Principal Investigator, Rio de Janeiro State University) — Principal investigator
First posted
May 11, 2017
Start date
Mar 1, 2016
Primary completion
Sep 30, 2017
Completion
Mar 30, 2018
Last update
Apr 12, 2018

Study contacts

Ciciliana MZ Rech
principal investigator · Universidade do Estado do Rio de Janeiro- BioVasc laboratory
Ruth Clapauch, PhD
study chair · Rio de Janeiro State University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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