Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal V… (NCT02739880) | Clinical Trial Compass
CompletedNot Applicable
Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule
France20 participantsStarted 2017-06-19
Plain-language 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.
Who can participate
Age range18 Years – 69 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* 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 hypersensitiv…
What they're measuring
1
The thickness of the vaginal mucosa on a histological section
Timeframe: Day 0
2
The thickness of the vaginal mucosa on a histological section