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 range
18 Years – 69 Years
Sex
FEMALE
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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