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Clinical Study to Evaluate the Efficacy of Prasterone Treatment for Atrophy Vulvovaginal in Postmenopausal Women With Vulvar / Vestibular Pain — ROSA  

Vulvovaginal Atrophy Clinical Trial

Official title:
Clinical Study to Evaluate the Efficacy of Prasterone Treatment for Atrophy Vulvovaginal in Postmenopausal Women With Vulvar / Vestibular Pain

Clinical Trial Summary

A prospective, open, randomized and controlled clinical intervention study in women over 45 years of age with a diagnosis of vulvovaginal atrophy (dryness and / or dyspareunia, etc.) and vulvar and / or vestibular pain. The efficacy of Prasterone treatment is evaluated in those patients willing to undergo the treatment compared to the control group.

Clinical Trial Description

A sample of 50 women over 45 years of age with at least one year of amenorrhea and who require treatment for vulvovaginal atrophy of moderate and / or severe intensity and who present vulvar and vaginal pain within these symptoms will be chosen. At the beginning of the study, after passing the selection criteria and signing the informed consent, the patients will be randomly assigned to one of the two arms of the study, (active group) or (control group), said assignment will be made randomly. Through a computer program where one or the other arm of treatment will be assigned to the patient at random to guarantee the homogeneity of both study groups and thus avoid selection biases. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04898556
Study type Interventional
Source Instituto Palacios
Contact Dr. Santiago Palacios Palacios, PI
Phone +34 91 578 05 17
Email ipalacios@institutopalacios.com
Status Recruiting
Phase Phase 3
Start date December 22, 2020
Completion date June 30, 2021
View Details
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