Hot Flash as a Marker of Cardiovascular Risk in Recent Postmenopause: Effects of Non-hormonal Treatments
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|ClinicalTrials.gov Identifier: NCT03149419|
Recruitment Status : Completed
First Posted : May 11, 2017
Last Update Posted : April 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Postmenopausal Flushing Cardiovascular Risk Factor Endothelial Dysfunction||Drug: Paroxetine Drug: Placebo oral capsule||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Endothelial, Autonomic and Pressure Effects of Paroxetine in Recent Postmenopause Women With Hot Flashes: a Randomized Placebo Controlled Clinical Trial|
|Actual Study Start Date :||March 1, 2016|
|Actual Primary Completion Date :||September 30, 2017|
|Actual Study Completion Date :||March 30, 2018|
Active Comparator: Paroxetine
Paroxetine 7,5 mg - 1 pill/day for 12 weeks
Placebo Comparator: Placebo
Placebo oral capsule (corn starch) - 1 pill/day for 12 weeks
Drug: Placebo oral capsule
- Endothelial function in non invasive venous occlusion plethysmography [ Time Frame: 12 weeks ]Forearm blood flow (ml/min per 100 ml)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149419
|Universidade do Estado do Rio de Janeiro|
|Rio de Janeiro, Brazil, 20550-900|
|Principal Investigator:||Ciciliana MZ Rech||Universidade do Estado do Rio de Janeiro- BioVasc laboratory|
|Study Chair:||Ruth Clapauch, PhD||Rio de Janeiro State University|