Ignite Creation Date:
2024-05-06 @ 2:05 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04219722
Status:
COMPLETED
Last Update Posted:
2023-04-10
First Post:
2019-12-18
Brief Title:
Efficacy and Safety of Hyaluronic Acid Injection on Symptoms of Vulvovaginal Atrophy in Postmenopausal Women
Sponsor:
Laboratoires Vivacy
Organization:
Laboratoires Vivacy
Study Overview
Official Title:
Treatment of Symptoms Associated With Vulvovaginal Atrophy in Postmenopausal Women by Hyaluronic Acid Injection Into the Vaginal Mucosa
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SYLIVA
Brief 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 21 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
Detailed 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 21 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 andor 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 timepointsGroup 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
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 21 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 andor 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 timepointsGroup 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None