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

NCT02739880 | Completed

• 2 other identifiers: LOCAL/2016/PM-0012016-A00124-47
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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

Menopause; Dyspareunia

Keywords

Vaginal discomfort; Vaginal dryness

Outcome Measures

Primary Outcomes (2)

• The thickness of the vaginal mucosa on a histological section

  Day 0

• The thickness of the vaginal mucosa on a histological section

  Week 8

Secondary Outcomes (15)

• Vaginal pH

  Day 0

• Vaginal pH

  Week 8

• Vaginal flora (on Pap smear)

  Day 0

• Vaginal flora (on Pap smear)

  Week 8

• Nugent score (on Pap smear)

  Day 0

Study Arms (1)

The study population

EXPERIMENTAL

The study population consists of postmenopausal patients (more than 2 years and less than 10 years) with a body mass index \<35 with sexual disorders (dyspareunia) or vaginal discomfort associated with vaginal dryness. Intervention: Intra-mucosal Injections of Cross-linked Hyaluronic Acid

Device: DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid)

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 / or treatment of female sexual dysfunction related to subsidence G "spot or area of Gräfenberg ". Following disinfection and topical anesthesia (lidocaine gel), the vesitbule is injected using a multi-point technique. The optimal volume of DESIRIAL® to be used for injection into the vestibule is approximately 0.3 ml in total.

Also known as: Cross-linked Hyaluronic Acid, DESIRIAL®

The study population

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The patient is participating in another 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
• The patient has a genital prolapse higher than stage 2 with a surgical indication
• The patient has stress incontinence with a surgical indication
• The patient suffers from vaginismus
• Presence of an untreated viral, fungal or bacterial vulvovaginal or urinary infection
• Hemorrhagic or neoplastic genital pathologies
• Existence of a hormone-dependent tumor, genital bleeding of unknown origin
• Current treatments based on antihypertensives, steroid anti-inflammatory drugs, anticoagulants, major antidepressants, aspirin
• Known hypersensitivity to hyaluronic acid or mannitol

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• Laboratoires Vivacy: collaborator

Study Sites (2)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Centre Médical KARIS

Perpignan, 66000, France

Location

Related Publications (1)

• Berreni N, Salerno J, Chevalier T, Alonso S, Mares P. Evaluation of the effect of multipoint intra-mucosal vaginal injection of a specific cross-linked hyaluronic acid for vulvovaginal atrophy: a prospective bi-centric pilot study. BMC Womens Health. 2021 Aug 28;21(1):322. doi: 10.1186/s12905-021-01435-w.

  PMID: 34454465 RESULT

MeSH Terms

Conditions

Dyspareunia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Nicolas Berreni, MD

  Centre Médical Karis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 15, 2016
• Study Start: June 19, 2017
• Primary Completion: September 6, 2018
• Study Completion: September 6, 2018
• Last Updated: November 21, 2025

Record last verified: 2019-03

Locations

FR (2)