Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule

What this trial studies

The main objective of this study is to measure changes in the thickness of the vaginal lining (epithelium + underlying stroma) between 0 and 8 weeks after injection.

Conditions in scope

• Menopause
• Dyspareunia

Interventions

• DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid) (Device) — Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule The intervention is Intended for intra-mucosal injection in women for biostimulation / rehydration of the surface layers of the lining of the genital areas, vaginal hypotrophies and /…

Who can join

Women only · Ages 18 Years to 69 Years

Inclusion criteria

• The patient must have given her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient is available for 8 weeks of follow-up
• The patient is menopausal (amenorrhea) for over 2 years and less than 10 years
• The patient has a body mass index \<35
• The patient has sexual disorders (dyspareunia) or vaginal discomfort associated with vaginal dryness.

Exclusion criteria

• The patient is participating in another study
• The patient is in an exclusion period determined by a previous study
• The patient is under judicial protection, under tutorship or curatorship
• The patient refuses to sign the consent
• It is impossible to correctly inform the patient
• The patient is pregnant or breastfeeding
• The patient is not menopausal (both clinically and biologically)
• The patient has a body mass index \> 35

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2017-06-19
• Primary completion: 2018-09-06
• Last update posted: 2025-11-21
• First posted: 2016-04-15

Sponsor & contact

Lead sponsor: Centre Hospitalier Universitaire de Nīmes (Other)

Collaborators: Laboratoires Vivacy

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• The thickness of the vaginal mucosa on a histological section (Day 0)
• The thickness of the vaginal mucosa on a histological section (Week 8)

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.