Vulvovaginal AtrophySYLIVANCT04219722
Efficacy and Safety of Hyaluronic Acid Injection on Symptoms of Vulvovaginal Atrophy in Postmenopausal Women
A study testing Injection of DESIRIAL® in people with Vulvovaginal Atrophy, run by Laboratoires Vivacy at 14 sites in 2 countries.
Trial summary
DESIRIAL® is a CE-marketed hyaluronic acid gel intented to rehydrate vaginal and vestibular mucous membranes by mucosal injections. In this study, 121 postmenopausal women of minimum age 45 with symptoms associated with vulvovaginal atrophy, refusing estrogen therapies for treatment of symptoms or with… Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Vulvovaginal Atrophy
- What is being tested?
- Injection of DESIRIAL®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 21 Jan 2020to 18 Jun 2022
- 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 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 45 years of age at inclusion;
- With postmenopausal status: at least 12 months of spontaneous amenorrhea or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy at the time of inclusion. Hormone-dependent breast cancer survivors previously treated with long-term anti-estrogen treatment tamoxifene, in complete remission of breast cancer, and with a post-menopause diagnosis after tamoxifene discontinuation are eligible;
- Refusing estrogen therapies for treatment of vulvovaginal symptomatology or with contraindications for such therapies;
- With at least one of the following vulvovaginal symptoms, as moderate to severe, self-assessed: Dryness sensation, Dyspareunia, Itching / irritation, Pain. Possible scores are 0 - none, 1 - mild, 2 - moderate, 3 - severe;
- Subject affiliated to a health social security system (if applicable according to national regulation);
- Informed consent signed by the patient for study enrolment.
Who cannot join
- Women with the following conditions:
- General:
- Pregnancy;
- Breast feeding;
- With a known tendency to develop hypertrophic or keloid scars;
- Participating at the same time in another clinical trial;
Show all 33Show fewer
- Deprived of their freedom by administrative or legal decision or under trusteeship/guardianship;
- With a known and documented hypernatremia;
- With a known and documented hyperchloremia;
- With a severe case of hydric inflation and hydro-sodic retention, particularly in case of decompensated heart failure, decompensated liver failure (cirrhosis with oedema and ascites), and pre-eclampsia / eclampsia.
- Linked to genital status: With a stage 2 upper genital tract prolapse indicated for surgery.
- Linked to inflammatory or immune status:
- With a known hypersensitivity to one of DESIRIAL®'s components (hyaluronic acid, mannitol), to the antiseptic solution, to amide local anesthetics or to one of the components of anesthesia products planned to be used;
- Presence of clinical signs of inflammation in or close to the area of interest or treatment for these affections;
- History of or ongoing autoimmune disease.
- Linked to infection:
- Presence of bacterial, fungal or viral infection in or close to the area of interest or treatment for these affections;
- With previous history of streptococcal illness (such as recurrent sore throat or acute articular rheumatism);
- History of Toxic Shock Syndrome.
- Linked to neoplasia:
- Ongoing or history of cancer in areas close to the injection site (vulvar, vaginal or cervical cancers);
- Ongoing cancer distant from the injection site. Hormone-dependent breast cancer survivors must be in complete remission after anti-estrogen treatment (tamoxifen, aromatase inhibitor) to be eligible.
- Linked to previous or ongoing treatments:
- Anti-estrogen treatment (tamoxifen, aromatase inhibitor) for hormone-dependent breast cancer within 1 year prior to inclusion;
- Treatment with a trophically targeted electromagnetic treatment of the vaginal mucosa (pulsed CO2 laser, LED, radiofrequency, etc.) within 6 months prior to inclusion;
- Treatment with anticoagulant, antiplatelet agents, NSAIDs or Vitamin C within 1 week prior to inclusion;
- Local hyaluronic acid-like hydrating treatment within 4 weeks prior to inclusion;
- Under hormonal treatment: Local vaginal estrogen alone including phytoestrogen, or estrogen-progestogen (rings, creams, ovules, gels) therapy within 1 week prior to inclusion; transdermal estrogen alone or estro-progestogen therapy within 4 weeks prior to inclusion; Tibolone within 4 weeks prior to inclusion; Oral estrogen alone including phytoestrogen, progestogen alone, or estro-progestogen therapy within 8 weeks prior to inclusion; Androgen therapy (including oral or vaginal DHEA) within 8 weeks prior to inclusion; Intrauterine progestogen therapy within 8 weeks prior to inclusion; Progestogen implants or estrogen alone injectable therapy within 3 months prior to inclusion; Estrogen pellet therapy or progestogen injectable therapy within 6 months prior to inclusion;
- Selective estrogen receptor modulator (SERM) treatment targeted against vaginal dryness (Ospemifene, etc) within 4 weeks prior to inclusion;
- Antidepressant agents within 4 weeks prior to inclusion;
- History of vulvovaginal treatment with DESIRIAL® or similar indication implants (resorbable or slowly resorbable) within 1 year prior to inclusion;
- History of vestibular and/or vaginal treatment with non resorbable implants;
- Total injection volume of cross-linked hyaluronic acid >19 mL within 1 year prior to inclusion.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
France8 sites
Clinique Georges V
Bordeaux, 33300
CHRU Jeanne de Flandres
Lille, 59037
Cabinet de gynécologie
Marseille, 13008
Cabinet de Gynécologie
Paris, 75016
Cabinet de gynécologie
Perpignan, 66000
Polyclinique de l'Atlantique
Saint-Herblain, 44800
Cabinet de Gynécologie
Tarnos, 40220
Cabinet de gynécologie
Toulouse, 31000
Belgium6 sites
Gynecology private office
Antwerp, 2018
Cabinet Gynécologie Obstétrique
Liège, 4000
Gynaecologisch Centrum
Mechelen, 2800
Gynaecologie Dr Deniz Gulcan
Meise, 1860
Cabinet Dr Ali Bennani
Wavre, 1300
MIRHA
Zaventem, 1930
About this study
Official title: Treatment of Symptoms Associated With Vulvovaginal Atrophy in Postmenopausal Women by Hyaluronic Acid Injection Into the Vaginal Mucosa
DESIRIAL® is a CE-marketed hyaluronic acid gel intented to rehydrate vaginal and vestibular mucous membranes by mucosal injections. In this study, 121 postmenopausal women of minimum age 45 with symptoms associated with vulvovaginal atrophy, refusing estrogen therapies for treatment of symptoms or with contraindications for such therapies, with at least one moderate to severe vulvovaginal symptom among dryness sensation, dyspareunia, itching / irritation and pain, who have given her informed consent and met all the eligibility criteria, will be enrolled. Patients will randomly receive 1 injection of DESIRIAL® or placebo (ratio 2:1) in the vaginal mucosa at Day 0. If still eligible 12 weeks after, patients receiving placebo at Day 0 will be treated with DESIRIAL®. Patients will come to a total of 6 to 8 visits depending on the product injected at Day 0 over a period of 11 up to 12 months. Phone interview will be performed between 3 and 5 days after injection. Variation of vulvovaginal symptomatology, sexual function, vaginal pH and safety will be assessed.
Read the detailed description
This is a prospective, international, multicenter study performed in 2 steps:
- From 0 to 12 weeks: randomized, single-blind, placebo-controlled study;
- From 12 to 52 weeks: open label, treatment only study.
The study will assess the efficacy of DESIRIAL® in reducing the vulvovaginal symptomatology after a single injection. One hundred twenty one postmenopausal women of minimum age 45, with symptoms associated with vulvovaginal atrophy, refusing estrogen therapies for treatment of symptoms or with contraindications for such therapies, with at least one moderate to severe vulvovaginal symptom among dryness sensation, dyspareunia, itching / irritation and pain, who have given her informed consent and met all the eligibility criteria, will be enrolled. Patients will randomly (2:1 ratio) receive a 1mL-injection of DESIRIAL® (Desirial Only group, DO) or placebo (Placebo and Desirial group, PAD) in the vestibular and vaginal mucosa using the multi-puncture and/or retrolinear technique at D0. If still eligible 12 weeks after, patients from PAD group receiving placebo at Day 0 will be treated with DESIRIAL®. Group DO will be followed up at 4, 12, 24, 36 and 52 weeks timepoints.Group PAD will be followed up at 4, 12, 16, 24, 36 and 48 weeks timepoints. Phone interview will be performed between 3 and 5 days after injection to check safety. Variation of vulvovaginal symptomatology, sexual function and vaginal pH will be measured using vulvovaginal symptomatology questionnaire, Female Sexual Function Index (FSFI) and vaginal pH indicator strip respectively. Safety will also be assessed through collection of adverse events.
- Conditions
- Vulvovaginal Atrophy
- Being tested
- Injection of DESIRIAL®, Injection of placebo
- Keywords
- Vaginal dryness, Vulvovaginal symptoms, Hyaluronic acid, Injection, Postmenopause, Prospective, 2-step study, Single-blind, Randomized, Placebo, Open study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of DESIRIAL®Device
Also called Injection of hyaluronic acid gel
DESIRIAL® is a hyaluronic acid injectable gel intended to treat symptoms associated with vulvovaginal atrophy in postmenopausal women by vaginal mucosa rehydration in this study.
1 mL of DESIRIAL® will be injected in the vestibule and on the posterior and lateral walls of the vagina, 2 to 3 cm after the introitus.
Injection of placeboOther
Also called Injection of NaCl 0.9%
Placebo is an isotonic saline solution (0.9% NaCl).
1 mL of placebo will be injected in the vestibule and on the posterior and lateral walls of the vagina, 2 to 3 cm after the introitus.
| Study group | Role | What they receive |
|---|---|---|
| Desirial only group | Active comparator | Administration of DESIRIAL® at Day 0 (Visit 1) Receives: Device: Injection of DESIRIAL® |
| Placebo and Desirial group | Placebo comparator | Administration of placebo at Day 0 (Visit 1). If still eligible 12 weeks (Visit 3) after placebo injection, patient will be treated with DESIRIAL® Receives: Device: Injection of DESIRIAL®; Other: Injection of placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of most bothersome symptom
Changes in mean Most Bothersome Symptom (MBS) severity score from baseline (Visit 1) to 12 weeks after a single injection of DESIRIAL® in comparison to a placebo (DO group versus PAD group).
Symptom intensity is assessed using a 4-score scale (from 0 to 3) with minimum score representing a better outcome. Score 0 corresponds to "None", score 1 to "Mild", score 2 to "Moderate" and score 3 to "Severe".
Measured: 12 weeks after Day 0
Secondary outcomes (6)
Variation of most bothersome symptom (MBS)
Changes in mean severity score of MBS after a single injection of DESIRIAL® as detailed:
- From baseline (V1) to 4 weeks after a single injection of DESIRIAL® in comparison to placebo (DO versus PAD group);
- From baseline (Visit 1) to 4, 24, 36 and 52 weeks post-injection for patients in DO group;
- From Visit 3 (12 weeks) to 16, 24, 36 and 48 weeks for patients in PAD group.
Symptom intensity is assessed using a 4-score scale (from 0 to 3) with minimum score representing a better outcome. Score 0 corresponds to "None", score 1 to "Mild", score 2 to "Moderate" and score 3 to "Severe".
Measured: 4 weeks, 12 weeks, 16 weeks, 24 weeks, 36 weeks, 48 weeks and 52 weeks after Day 0
Variation of other moderate to severe symptoms
Changes in mean severity score of other moderate to severe symptoms after a single injection of DESIRIAL® as detailed:
- From baseline (Visit 1) to 4 and 12 weeks after a single injection of DESIRIAL® in comparison to placebo (DO versus PAD group);
- From baseline (Visit 1) to 4, 12, 24, 36 and 52 weeks post-injection for patients in DO group;
- From Visit 3 (12 weeks) to 16, 24, 36 and 48 weeks for patients in PAD group.
Symptom intensity is assessed using a 4-score scale (from 0 to 3) with minimum score representing a better outcome. Score 0 corresponds to "None", score 1 to "Mild", score 2 to "Moderate" and score 3 to "Severe".
Measured: 4 weeks, 12 weeks, 16 weeks, 24 weeks, 36 weeks, 48 weeks and 52 weeks after Day 0
Percentage of responders
Percentages of patients with a most bothersome symptom score less than or equal to 1 (mild) at week 12 in comparison to placebo (DO group versus PAD group)
Measured: 12 weeks after Day 0
Variation of sexual function
Changes in Female Sexual Function Index (FSFI) scores after a single DESIRIAL® injection:
- From baseline (Visit 1) to 4 and 12 weeks after a single injection of DESIRIAL® in comparison to a placebo (DO group versus PAD group);
- From baseline (Visit 1) to 4, 12, 24, 36 and 52 weeks post-injection for patients in DO group;
- From Visit 3 at 12 weeks to 16, 24, 36 and 48 weeks for patients in PAD group.
FSFI consists in 19 questions with multiple-choice responses coded from 0.0 to 5.0. Each score has a specific meaning depending on the question. The scale has six sexual domains. The maximum score for each domain is 6.0, obtained by summing item responses and multiplying by a correction factor. The total composite sexual function score is a sum of domain scores and ranges from 2.0 (not sexually active and no desire) to 36.0.
Measured: 4 weeks, 12 weeks, 16 weeks, 24 weeks, 36 weeks, 48 weeks and 52 weeks after Day 0
Variation of vaginal pH
Changes in pH after a single DESIRIAL® injection:
- From baseline (Visit 1) to 4 and 12 weeks after a single injection of DESIRIAL® in comparison to a placebo (DO group versus PAD group);
- From baseline (Visit 1) to 4, 12, 24, 36 and 52 weeks post-injection for patients in DO group;
- From Visit 3 (12 weeks) to 16, 24, 36 and 48 weeks for patients in PAD group.
Measured: 4 weeks, 12 weeks, 16 weeks, 24 weeks, 36 weeks, 48 weeks and 52 weeks after Day 0
Report of adverse events
Evaluation of product tolerance by collection of adverse events
Measured: Through study completion, up to 52 weeks for DO group and up to 48 weeks for PAD group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start21 Jan 2020
- Primary completion29 Sep 2021
- Study completion18 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vulvovaginal 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
- Study performed in two steps: * From 0 to 12 weeks: randomized, single-blind, placebo-controlled study * From 12 to 52 weeks: open label, treatment only study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Vivacy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219722
- Sponsor's protocol ID
- 2019-A00034-53
- Acronym
- SYLIVA
- Status last verified
- Apr 2023
- First submitted
- 18 Dec 2019
- Last updated
- 10 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bensmail H, Marchand Lamiraud F, Martin C, Pelckmans S, Cha'ban F, Siboni Frisch A, Deniz G, Sabban Serfati P, Caubo B, Gurriet B, Petit Breuilh I, Pastijn AI, Berreni N, Cosson M. Hyaluronic acid injection to treat symptoms of vulvovaginal atrophy and improve sexual function in postmenopausal women: A 52-week long-term follow-up. Maturitas. 2025 Oct;201:108687. doi: 10.1016/j.maturitas.2025.108687. Epub 2025 Aug 5.
PubMed 40773978Marchand Lamiraud F, Bensmail H, Martin C, Pelckmans S, Cha'ban F, Siboni Frisch A, Deniz G, Sabban Serfati P, Caubo B, Gurriet B, Petit Breuilh I, Pastijn AI, Berreni N, Cosson M. Hyaluronic acid injection to treat symptoms of vulvovaginal atrophy in postmenopausal women: A 12-week randomised, placebo-controlled, multicentric study. Maturitas. 2025 Jun;197:108264. doi: 10.1016/j.maturitas.2025.108264. Epub 2025 Apr 12.
PubMed 40273666
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Symptoms Associated With Vulvovaginal Atrophy in Postmenopausal Women by Hyaluronic Acid Injection Into the Vaginal Mucosa
- ClinicalTrials.gov ID
- NCT04219722
- Acronym / sponsor ID
- SYLIVA / 2019-A00034-53
- Conditions
- Vulvovaginal Atrophy
- Keywords
- Vaginal dryness, Vulvovaginal symptoms, Hyaluronic acid, Injection, Postmenopause, Prospective, 2-step study, Single-blind
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Laboratoires VivacyIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 18 Jun 2022 (actual)
- First posted
- 7 Jan 2020 (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.
DESIRIAL® is a CE-marketed hyaluronic acid gel intented to rehydrate vaginal and vestibular mucous membranes by mucosal injections. In this study, 121 postmenopausal women of minimum age 45 with symptoms associated with vulvovaginal atrophy, refusing estrogen therapies for treatment of symptoms or with contraindications for such therapies, with at least one moderate to severe vulvovaginal symptom among dryness sensation, dyspareunia, itching / irritation and pain, who have given her informed consent and met all the eligibility criteria, will be enrolled. Patients will randomly receive 1 injection of DESIRIAL® or placebo (ratio 2:1) in the vaginal mucosa at Day 0. If still eligible 12 weeks after, patients receiving placebo at Day 0 will be treated with DESIRIAL®. Patients will come to a total of 6 to 8 visits depending on the product injected at Day 0 over a period of 11 up to 12 months. Phone interview will be performed between 3 and 5 days after injection. Variation of vulvovaginal symptomatology, sexual function, vaginal pH and safety will be assessed.
Detailed description
This is a prospective, international, multicenter study performed in 2 steps:
- From 0 to 12 weeks: randomized, single-blind, placebo-controlled study;
- From 12 to 52 weeks: open label, treatment only study.
The study will assess the efficacy of DESIRIAL® in reducing the vulvovaginal symptomatology after a single injection. One hundred twenty one postmenopausal women of minimum age 45, with symptoms associated with vulvovaginal atrophy, refusing estrogen therapies for treatment of symptoms or with contraindications for such therapies, with at least one moderate to severe vulvovaginal symptom among dryness sensation, dyspareunia, itching / irritation and pain, who have given her informed consent and met all the eligibility criteria, will be enrolled. Patients will randomly (2:1 ratio) receive a 1mL-injection of DESIRIAL® (Desirial Only group, DO) or placebo (Placebo and Desirial group, PAD) in the vestibular and vaginal mucosa using the multi-puncture and/or retrolinear technique at D0. If still eligible 12 weeks after, patients from PAD group receiving placebo at Day 0 will be treated with DESIRIAL®. Group DO will be followed up at 4, 12, 24, 36 and 52 weeks timepoints.Group PAD will be followed up at 4, 12, 16, 24, 36 and 48 weeks timepoints. Phone interview will be performed between 3 and 5 days after injection to check safety. Variation of vulvovaginal symptomatology, sexual function and vaginal pH will be measured using vulvovaginal symptomatology questionnaire, Female Sexual Function Index (FSFI) and vaginal pH indicator strip respectively. Safety will also be assessed through collection of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Study performed in two steps: * From 0 to 12 weeks: randomized, single-blind, placebo-controlled study * From 12 to 52 weeks: open label, treatment only study
| Arm | Type | Receives |
|---|---|---|
| Desirial only group | Active comparator | Device: Injection of DESIRIAL®Administration of DESIRIAL® at Day 0 (Visit 1) |
| Placebo and Desirial group | Placebo comparator | Device: Injection of DESIRIAL®, Other: Injection of placeboAdministration of placebo at Day 0 (Visit 1). If still eligible 12 weeks (Visit 3) after placebo injection, patient will be treated with DESIRIAL® |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 45 years of age at inclusion;
- With postmenopausal status: at least 12 months of spontaneous amenorrhea or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy at the time of inclusion. Hormone-dependent breast cancer survivors previously treated with long-term anti-estrogen treatment tamoxifene, in complete remission of breast cancer, and with a post-menopause diagnosis after tamoxifene discontinuation are eligible;
- Refusing estrogen therapies for treatment of vulvovaginal symptomatology or with contraindications for such therapies;
- With at least one of the following vulvovaginal symptoms, as moderate to severe, self-assessed: Dryness sensation, Dyspareunia, Itching / irritation, Pain. Possible scores are 0 - none, 1 - mild, 2 - moderate, 3 - severe;
- Subject affiliated to a health social security system (if applicable according to national regulation);
Key exclusion criteria (33 listed)
- General:
- Linked to genital status: With a stage 2 upper genital tract prolapse indicated for surgery.
- Linked to inflammatory or immune status:
- Linked to infection:
- Linked to neoplasia:
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 |
|---|---|---|
| Injection of DESIRIAL®Also: Injection of hyaluronic acid gelDESIRIAL® is a hyaluronic acid injectable gel intended to treat symptoms associated with vulvovaginal atrophy in postmenopausal women by vaginal mucosa rehydration in this study. 1 mL of DESIRIAL® will be injected in the vestibule and on the posterior and lateral walls of the vagina, 2 to 3 cm after the introitus. | Device | Desirial only group, Placebo and Desirial group |
| Injection of placeboAlso: Injection of NaCl 0.9%Placebo is an isotonic saline solution (0.9% NaCl). 1 mL of placebo will be injected in the vestibule and on the posterior and lateral walls of the vagina, 2 to 3 cm after the introitus. | Other | Placebo and Desirial group |
Primary outcome
Variation of most bothersome symptom
Time frame: 12 weeks after Day 0
Changes in mean Most Bothersome Symptom (MBS) severity score from baseline (Visit 1) to 12 weeks after a single injection of DESIRIAL® in comparison to a placebo (DO group versus PAD group). Symptom intensity is assessed using a 4-score scale (from 0 to 3) with minimum score representing a better outcome. Score 0 corresponds to "None", score 1 to "Mild", score 2 to "Moderate" and score 3 to "Severe".
6 secondary outcomes
Variation of most bothersome symptom (MBS)
Time frame: 4 weeks, 12 weeks, 16 weeks, 24 weeks, 36 weeks, 48 weeks and 52 weeks after Day 0
Variation of other moderate to severe symptoms
Time frame: 4 weeks, 12 weeks, 16 weeks, 24 weeks, 36 weeks, 48 weeks and 52 weeks after Day 0
Percentage of responders
Time frame: 12 weeks after Day 0
Variation of sexual function
Time frame: 4 weeks, 12 weeks, 16 weeks, 24 weeks, 36 weeks, 48 weeks and 52 weeks after Day 0
Variation of vaginal pH
Time frame: 4 weeks, 12 weeks, 16 weeks, 24 weeks, 36 weeks, 48 weeks and 52 weeks after Day 0
Report of adverse events
Time frame: Through study completion, up to 52 weeks for DO group and up to 48 weeks for PAD group
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 10 Apr 2023.
- Derived from this study: PubMed 40773978Bensmail H, Marchand Lamiraud F, Martin C, Pelckmans S, Cha'ban F, Siboni Frisch A, Deniz G, Sabban Serfati P, Caubo B, Gurriet B, Petit Breuilh I, Pastijn AI, Berreni N, Cosson M. Hyaluronic acid injection to treat symptoms of vulvovaginal atrophy and improve sexual function in postmenopausal women: A 52-week long-term follow-up. Maturitas. 2025 Oct;201:108687. doi: 10.1016/j.maturitas.2025.108687. Epub 2025 Aug 5.
- Derived from this study: PubMed 40273666Marchand Lamiraud F, Bensmail H, Martin C, Pelckmans S, Cha'ban F, Siboni Frisch A, Deniz G, Sabban Serfati P, Caubo B, Gurriet B, Petit Breuilh I, Pastijn AI, Berreni N, Cosson M. Hyaluronic acid injection to treat symptoms of vulvovaginal atrophy in postmenopausal women: A 12-week randomised, placebo-controlled, multicentric study. Maturitas. 2025 Jun;197:108264. doi: 10.1016/j.maturitas.2025.108264. Epub 2025 Apr 12.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of DESIRIAL® in people with Vulvovaginal Atrophy, run by Laboratoires Vivacy at 14 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 6 inclusion and 33 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 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France, Belgium. 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. Some participants in this study may receive a placebo. 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?
Variation of most bothersome symptom (time frame: 12 weeks after Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04219722, which also lists 2 linked publications.
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 10 Apr 2023.