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Efficacy and Safety of Hyaluronic Acid Injection on Symptoms of Vulvovaginal Atrophy in Postmenopausal Women — SYLIVA  

Vulvovaginal Atrophy Clinical Trial

Official title:
Treatment of Symptoms Associated With Vulvovaginal Atrophy in Postmenopausal Women by Hyaluronic Acid Injection Into the Vaginal Mucosa

Clinical Trial Summary

DESIRIAL® is a CE-marketed hyaluronic acid gel intented to rehydrate vaginal and vestibular mucous membranes by mucosal injections. In this study, 121 postmenopausal women of minimum age 45 with symptoms associated with vulvovaginal atrophy, refusing estrogen therapies for treatment of symptoms or with contraindications for such therapies, with at least one moderate to severe vulvovaginal symptom among dryness sensation, dyspareunia, itching / irritation and pain, who have given her informed consent and met all the eligibility criteria, will be enrolled. Patients will randomly receive 1 injection of DESIRIAL® or placebo (ratio 2:1) in the vaginal mucosa at Day 0. If still eligible 12 weeks after, patients receiving placebo at Day 0 will be treated with DESIRIAL®. Patients will come to a total of 6 to 8 visits depending on the product injected at Day 0 over a period of 11 up to 12 months. Phone interview will be performed between 3 and 5 days after injection. Variation of vulvovaginal symptomatology, sexual function, vaginal pH and safety will be assessed.

Clinical Trial Description

This is a prospective, international, multicenter study performed in 2 steps: - From 0 to 12 weeks: randomized, single-blind, placebo-controlled study; - From 12 to 52 weeks: open label, treatment only study. The study will assess the efficacy of DESIRIAL® in reducing the vulvovaginal symptomatology after a single injection. One hundred twenty one postmenopausal women of minimum age 45, with symptoms associated with vulvovaginal atrophy, refusing estrogen therapies for treatment of symptoms or with contraindications for such therapies, with at least one moderate to severe vulvovaginal symptom among dryness sensation, dyspareunia, itching / irritation and pain, who have given her informed consent and met all the eligibility criteria, will be enrolled. Patients will randomly (2:1 ratio) receive a 1mL-injection of DESIRIAL® (Desirial Only group, DO) or placebo (Placebo and Desirial group, PAD) in the vestibular and vaginal mucosa using the multi-puncture and/or retrolinear technique at D0. If still eligible 12 weeks after, patients from PAD group receiving placebo at Day 0 will be treated with DESIRIAL®. Group DO will be followed up at 4, 12, 24, 36 and 52 weeks timepoints.Group PAD will be followed up at 4, 12, 16, 24, 36 and 48 weeks timepoints. Phone interview will be performed between 3 and 5 days after injection to check safety. Variation of vulvovaginal symptomatology, sexual function and vaginal pH will be measured using vulvovaginal symptomatology questionnaire, Female Sexual Function Index (FSFI) and vaginal pH indicator strip respectively. Safety will also be assessed through collection of adverse events. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04219722
Study type Interventional
Source Laboratoires Vivacy
Contact
Status Completed
Phase N/A
Start date January 21, 2020
Completion date June 18, 2022
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