Vulvar AtrophyNCT06333782
Evaluation of the Safety and Efficacy of Hyaluronic Acid Injection in Labia Majora Augmentation
A study testing Experimental- Genefill Contour® and Marketed comparator - Desirial®Plus in people with Vulvar Atrophy, run by Bioscience Cosmetics SL at 3 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvar Atrophy
- What is being tested?
- Experimental- Genefill Contour® and Marketed comparator - Desirial®Plus
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 13 May 2024to 3 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites
Cabinet renaissance
Levallois-Perret, Paris, 92300
Palais Flore
Lyon, Lyon, 69006
About this study
Official title: Prospective, Multicentric, Single Blind, Randomized Study on the Evaluation of the Safety and Efficacy of Genefill Contour® Versus Comparator in Labia Majora Augmentation
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®. The secondary objectives is effectivenes of the investigational device (improvement of patient´s symptoms, patient´s satisfaction, sexual function \& pain during injection).
Read more
Participants will come to a total of 8 visits (including 2 phone calls) over a period of 12 months. Participants would be enrolled in Genefill Contour® or comparator group.
An ancillary study would be conducted in a cohort of participants evaluating the increase in volume and distance between labia after HA injection
Read the detailed description
Prospective, Multicentric, Single Blind, Randomized study on the evaluation of the safety and efficacy of Genefill Contour versus comparator in labia majora augmentation. This study analyze the safety and efficacy of the investigational device versus comparator. Participants would be randomized 1:1 between 2 arms (Genefill Contour vs comparator). The study duration is 12 months and will consist in 8 visits (Screening visit, 5 on site visit and 2 phone calls). At week 4, an optional touch-up may be conducted. 110 participants are expected to be included in the trial.
The primary objective is the evaluation of the safety of Genefill Contour®. The secondary objectives is effectivenes of the investigational device (improvement of patient´s symptoms, patient´s satisfaction, sexual function \& pain during injection).
An ancillary study would be conducted in a cohort of participants evaluating the increase in volume and distance between labia after HA injection at W4 and W12.
- Conditions
- Vulvar Atrophy
- Being tested
- Experimental- Genefill Contour®, Marketed comparator - Desirial®Plus
- Keywords
- Labia Majora Atrophy, Labia Majora Hypotrophy, Labia Majora Augmentation, Genital rejuvenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental- Genefill Contour®Device
Genefill Contour® Hyaluronic Acid Injection
Marketed comparator - Desirial®PlusDevice
DESIRIAL®PLUS Hyaluronic Acid Injection
| Study group | Role | What they receive |
|---|---|---|
| Genefill Contour® | Experimental | Participants will be injected with the investigational device Genefill Contour at Visit 1, and Visit 2 only if touch-up needed. Receives: Device: Experimental- Genefill Contour® |
| Comparator (Desirial®Plus) | Active comparator | Participants would be injected with the marketed comparator (Desirial Plus) at Visit 1, and Visit 2 only if touch-up needed. Receives: Device: Marketed comparator - Desirial®Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of number of occurred ADEs (Adverse device effects)
Collection of ADEs by patients having received injection with Genefill Contour versus Desirial Plus after 52 weeks of use
Measured: During 4 weeks after injection: from Visit 1 to Visit 2 (week 4) and from Visit 2 (week 4) to week 8 only if Touch-up done at Visit 2.
Secondary outcomes (7)
Global Aesthetic Improvement Scale (GAIS) assessment by investigator
Effectiveness of investigational device versus comparator assessed by the investigator using GAIS.
GAIS score (1-5) as following:
1 =very much improved 2= Much improved 3=Improved 4= No change 5= Worse
Measured: Week 4, Week 12, Week 24 & Week 52
Global Aesthetic Improvement Scale (GAIS) assessment by participant
Effectiveness of investigational device versus comparator assessed by the participant using GAIS.
GAIS score (1-5) as following:
1 =very much improved 2= Much improved 3=Improved 4= No change 5= Worse
Measured: Week 4, Week 12, Week 24 & Week 52
Patient (Atrophy/Hypotrophy) symptoms
Effectiveness of investigational device (Genefill Contour) versus comparator (Desirial Plus) on patient's symptoms.
A scale from 0 (abscent) to 10 (intolerance) of the following symptoms:
- Irritation/Burning during daily life
- Irritation/Burning during sport
- Iching
- Stinging
- Dryness
Measured: Week 4, Week 12, Week 24 & Week 52
Sexual function Assessment, The Female Sexual Function Index (FSFI)
Effectiveness of investigational device Genefill Contour) versus comparator (Desirial Plus) on sexual function.
Patient will be asked about her sexual life, and the answers will be scored from 1 to 5, being 1 as the worst situation and 5 the best.
Measured: Week 4, Week 12, Week 24, Week 36 & Week 52
Patient´s satisfaction
Effectiveness of investigational device (Genefill Contour) versus comparator (Desirial Plus) on patient's satisfaction.
The patient will be asked about global satisfaction of the treatment and results. The options of the answers are as follows:
- Very satisfied
- Satisfied
- Unsatisfied
- Very Unsatisfied
Measured: Week 4, Week 12, Week 24, Week 36 & Week 52
Pain during injection-Visual Analogical Scale (VAS)
Pain assessed by participant immediatly after the injection using Visual Analogical Scale (VAS) at Visit 1 and Visit 2 (only if touch-up is needed).
The rating is from 0 cm (No pain) to 10 cm(Worst pain possible)
Measured: After the injection at Visit 1 (Day 0) and Visit 2 ( Week 4)
Adverse Events collection (Global safety during the study period)
Collection of unsolicited adverse events from screening Visit to 52 weeks after first injection.
AE severity range of grades:
0=mild
- moderate
- Severe
Measured: During the whole study, up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start13 May 2024
- Primary completion3 Apr 2026
- Study completion3 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants would be randomized on two groups: Genefill Contour or comparator (Desirial Plus) at a ratio 1:1
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioscience Cosmetics SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins
- Responsible party
- Sponsor
- Investigators
- Silvia Fontenete, PhD, MBA, Study director, Bioscience Cosmetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333782
- Sponsor's protocol ID
- 2023-EU-GEN-01
- Other IDs
- 2023-A02012-43
- Status last verified
- Oct 2026
- First submitted
- 13 Dec 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentric, Single Blind, Randomized Study on the Evaluation of the Safety and Efficacy of Genefill Contour® Versus Comparator in Labia Majora Augmentation
- ClinicalTrials.gov ID
- NCT06333782
- Acronym / sponsor ID
- 2023-EU-GEN-01
- Conditions
- Vulvar Atrophy
- Keywords
- Labia Majora Atrophy, Labia Majora Hypotrophy, Labia Majora Augmentation, Genital rejuvenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Bioscience Cosmetics SLIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins
- Study start
- 13 May 2024 (actual)
- Primary completion
- 3 Apr 2026 (actual)
- Study completion
- 3 Apr 2026 (actual)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®. The secondary objectives is effectivenes of the investigational device (improvement of patient´s symptoms, patient´s satisfaction, sexual function \& pain during injection).
Participants will come to a total of 8 visits (including 2 phone calls) over a period of 12 months. Participants would be enrolled in Genefill Contour® or comparator group.
An ancillary study would be conducted in a cohort of participants evaluating the increase in volume and distance between labia after HA injection
Detailed description
Prospective, Multicentric, Single Blind, Randomized study on the evaluation of the safety and efficacy of Genefill Contour versus comparator in labia majora augmentation. This study analyze the safety and efficacy of the investigational device versus comparator. Participants would be randomized 1:1 between 2 arms (Genefill Contour vs comparator). The study duration is 12 months and will consist in 8 visits (Screening visit, 5 on site visit and 2 phone calls). At week 4, an optional touch-up may be conducted. 110 participants are expected to be included in the trial.
The primary objective is the evaluation of the safety of Genefill Contour®. The secondary objectives is effectivenes of the investigational device (improvement of patient´s symptoms, patient´s satisfaction, sexual function \& pain during injection).
An ancillary study would be conducted in a cohort of participants evaluating the increase in volume and distance between labia after HA injection at W4 and W12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants would be randomized on two groups: Genefill Contour or comparator (Desirial Plus) at a ratio 1:1
| Arm | Type | Receives |
|---|---|---|
| Genefill Contour® | Experimental | Device: Experimental- Genefill Contour®Participants will be injected with the investigational device Genefill Contour at Visit 1, and Visit 2 only if touch-up needed. |
| Comparator (Desirial®Plus) | Active comparator | Device: Marketed comparator - Desirial®PlusParticipants would be injected with the marketed comparator (Desirial Plus) at Visit 1, and Visit 2 only if touch-up needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental- Genefill Contour®Genefill Contour® Hyaluronic Acid Injection | Device | Genefill Contour® |
| Marketed comparator - Desirial®PlusDESIRIAL®PLUS Hyaluronic Acid Injection | Device | Comparator (Desirial®Plus) |
Primary outcome
Mean of number of occurred ADEs (Adverse device effects)
Time frame: During 4 weeks after injection: from Visit 1 to Visit 2 (week 4) and from Visit 2 (week 4) to week 8 only if Touch-up done at Visit 2.
Collection of ADEs by patients having received injection with Genefill Contour versus Desirial Plus after 52 weeks of use
7 secondary outcomes
Global Aesthetic Improvement Scale (GAIS) assessment by investigator
Time frame: Week 4, Week 12, Week 24 & Week 52
Global Aesthetic Improvement Scale (GAIS) assessment by participant
Time frame: Week 4, Week 12, Week 24 & Week 52
Patient (Atrophy/Hypotrophy) symptoms
Time frame: Week 4, Week 12, Week 24 & Week 52
Sexual function Assessment, The Female Sexual Function Index (FSFI)
Time frame: Week 4, Week 12, Week 24, Week 36 & Week 52
Patient´s satisfaction
Time frame: Week 4, Week 12, Week 24, Week 36 & Week 52
Pain during injection-Visual Analogical Scale (VAS)
Time frame: After the injection at Visit 1 (Day 0) and Visit 2 ( Week 4)
Adverse Events collection (Global safety during the study period)
Time frame: During the whole study, up to 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Fontenete, PhD, MBA study director
Bioscience Cosmetics
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental- Genefill Contour® and Marketed comparator - Desirial®Plus in people with Vulvar Atrophy, run by Bioscience Cosmetics SL at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean of number of occurred ADEs (Adverse device effects) (time frame: During 4 weeks after injection: from Visit 1 to Visit 2 (week 4) and from Visit 2 (week 4) to week 8 only if Touch-up done at Visit 2.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.