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Tests treatment safety and results for Vulvar Atrophy
Official title Evaluation of the Safety and Efficacy of Hyaluronic Acid Injection in Labia Majora Augmentation
ClinicalTrials.gov ID: NCT06333782
What this study is testing
- What it's testing
- The goal of this interventional clinical investigation using Genefill Contour® CE marked device outside of its indication is to compare with other hyaluronic acid device already marketed for labia majora augmentation in women with labia majora hypotrophy/atrophy. The primary objective is the evaluation of the safety of Genefill Contour®.
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- Gender: female.
- Age: more than 18 years old.
- Patient affected by labia majora atrophy/hypotrophy as per investigator's judgement and expressing the wish for volume augmentation of the labia...
- Patient able to understand and sign the informed consent for study enrolment.
- Patient having given freely and expressly her informed consent.
You likely can't join if
- Pregnant or breastfeeding woman or planning a pregnancy during the study
- Women who gave birth within 4 months before inclusion.
- Patient who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- Patient in a social or sanitary establishment.
- Patient suspected to be non-compliant according to the investigator's judgment.
- Patient suffering from a severe or progressive disease.
See the full eligibility criteria
- Gender: female.
- Age: more than 18 years old.
- Patient affected by labia majora atrophy/hypotrophy as per investigator's judgement and expressing the wish for volume augmentation of the labia majora.
- Patient able to understand and sign the informed consent for study enrolment.
- Patient having given freely and expressly her informed consent.
- Patient affiliated to a health social security system.
- Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before inclusion and during all the study.
- Pregnant or breastfeeding woman or planning a pregnancy during the study
- Women who gave birth within 4 months before inclusion.
- Patient who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- Patient in a social or sanitary establishment.
- Patient suspected to be non-compliant according to the investigator's judgment.
- Patient suffering from a severe or progressive disease.
- Patient with history of auto immune disease.
- Patient immunosuppressed.
- Patient suffering of haemostatic disorder.
- Patient presenting with acute or chronic skin diseases.
- Patient is prone to active inflammatory or infectious processes or presenting clinical signs of inflammation in or close to the labia majora.
- Patient presenting bacterial, fungal or viral infection in or close to labia majora.
- Patient with history of streptococcal disease.
- Patient with recurrent genital herpes (several times a year). A patient asymptomatic in the 6 months before inclusion is eligible.
- Patient with history of pre-cancerous condition or cancer in areas close to the injection site (external urogenital, anal or vaginal).
- Patient with an actual cancer or presence of pre-cancerous cells (vulvar dysplasia).
- Patient with a known tendency to develop keloid or hypertrophic scars.
- Patient with known allergy or hypersensitivity to hyaluronic acid or to one of Genefill Contour, Desirial® Plus, anesthesia (if applicable) and disinfectant components.
- Patient with multiple allergies.
- Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk.
- Patient who started oestrogen therapies for treatment of vulvovaginal symptomatology within 3 months before inclusion.
- Patient under treatment for bacterial, fungal or viral infection.
- Patient under treatment with aspirin, anticoagulant, platelets aggregation inhibiting drugs, NSAIDs, immunosuppressive therapy and Vitamin C or treated within one week before inclusion.
- Patient under local hydrating treatment within four weeks before inclusion.
- Patient with history of correction with another resorbable implants with a similar indication within 12 months before inclusion.
- Patient with history of correction with permanent implants including fat graft or semi-permanent in the area of injection.
- Patient who underwent a surgery on labia minora within 12 months before inclusion.
- Patient who underwent a surgery on labia majora at any time.
- Patient having intolerance to gram-positive bacteria.
The study team makes the final eligibility decision.
Where it's taking place
- Levallois-Perret, Paris, France
- Lyon, France
- Gdansk, Gdansk, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Levallois-Perret, Paris, France; Lyon, France; Gdansk, Gdansk, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.