Status:
COMPLETED
Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Collaborating Sponsors:
Laboratoires Vivacy
Conditions:
Menopause
Dyspareunia
Eligibility:
FEMALE
18-69 years
Phase:
NA
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.
Detailed Description
The secondary objectives of this study are to measure changes in the following between 0 and 8 weeks after injection: A. vaginal flora and Nugent score. B. vaginal pH. C. functional evolution via t...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
- Known hypersensitivity to Betadine
- Known hypersensitivity to Lidocaine
- Hypersensitivity to EMLA®
- Previous urogynaecological vulvovaginal surgery
Key Trial Info
Start Date :
June 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02739880
Start Date
June 19 2017
End Date
September 6 2018
Last Update
November 21 2025
Active Locations (2)
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1
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France, 30029
2
Centre Médical KARIS
Perpignan, France, 66000