MenopauseINREG 1NCT02739880
Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule
A study testing DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid) in people with Menopause and Dyspareunia, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years, women only
- Conditions the study is for
- Menopause, Dyspareunia
- What is being tested?
- DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- 19 Jun 2017to 6 Sep 2018
- 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 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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 hypersensitivity to Betadine
- Known hypersensitivity to Lidocaine
- Hypersensitivity to EMLA®
- Previous urogynaecological vulvovaginal surgery
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
Centre Médical KARIS
Perpignan, 66000
About this study
Official title: Evaluation of the Effect of Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule: A Prospective, Bicentric, Pilot Study
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.
Read the detailed description
The secondary objectives of this study are to measure changes in the following between 0 and 8 weeks after injection:
- vaginal flora and Nugent score.
- vaginal pH.
- functional evolution via the VHI index by Gloria Bachman (state of the vaginal mucosa), pain / dyspareunia (visual analog scale) and the satisfaction concerning care viay the PGI-I questionnaire (Patient Global Impression and Improvement).
- Procollagen I and III gene expression (by PCR) and mitotic activity of the mucosa (Ki67 proliferation marker) based on biopsies.
- Conditions
- Menopause, Dyspareunia
- Being tested
- DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid)
- Keywords
- Vaginal discomfort, Vaginal dryness
- Medical subject headings
- Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid)Device
Also called Cross-linked Hyaluronic Acid, DESIRIAL®
Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule
The intervention is Intended for intra-mucosal injection in women for biostimulation / rehydration of the surface layers of the lining of the genital areas, vaginal hypotrophies and / or treatment of female sexual dysfunction related to subsidence G "spot or area of Gräfenberg ".
Following disinfection and topical anesthesia (lidocaine gel), the vesitbule is injected using a multi-point technique. The optimal volume of DESIRIAL® to be used for injection into the vestibule is approximately 0.3 ml in total.
| Study group | Role | What they receive |
|---|---|---|
| The study population | Experimental | The study population consists of postmenopausal patients (more than 2 years and less than 10 years) with a body mass index <35 with sexual disorders (dyspareunia) or vaginal discomfort associated with vaginal dryness.
Intervention: Intra-mucosal Injections of Cross-linked Hyaluronic Acid Receives: Device: DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The thickness of the vaginal mucosa on a histological section
Measured: Day 0
The thickness of the vaginal mucosa on a histological section
Measured: Week 8
Secondary outcomes (15)
Vaginal pH
Measured: Day 0
Vaginal pH
Measured: Week 8
Vaginal flora (on Pap smear)
Measured: Day 0
Vaginal flora (on Pap smear)
Measured: Week 8
Nugent score (on Pap smear)
Measured: Day 0
Nugent score (on Pap smear)
Measured: Week 8
PGI-I (Patient Global Impression and Improvement) Questionnaire
Measured: Week 8
The Vaginal Health Index by Gloria Bachman
Measured: Day 0
The Vaginal Health Index by Gloria Bachman
Measured: Week 8
Pain (dyspareunia) by visual analog scale
Measured: Day 0
Pain (dyspareunia) by visual analog scale
Measured: Week 8
Measurement of collagen expression (procollagen I and III)
Measured: Day 0
Measurement of collagen expression (procollagen I and III)
Measured: Week 8
Level of Ki67 proliferation marker
Measured: Day 0
Level of Ki67 proliferation marker
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study start19 Jun 2017
- Primary completion6 Sep 2018
- Study completion6 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoires Vivacy
- Responsible party
- Sponsor
- Investigators
- Nicolas Berreni, MD, Study director, Centre Médical Karis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739880
- Sponsor's protocol ID
- LOCAL/2016/PM-001
- Other IDs
- 2016-A00124-47
- Acronym
- INREG 1
- Status last verified
- Mar 2019
- First submitted
- 6 Apr 2016
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Berreni N, Salerno J, Chevalier T, Alonso S, Mares P. Evaluation of the effect of multipoint intra-mucosal vaginal injection of a specific cross-linked hyaluronic acid for vulvovaginal atrophy: a prospective bi-centric pilot study. BMC Womens Health. 2021 Aug 28;21(1):322. doi: 10.1186/s12905-021-01435-w.
PubMed 34454465
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule: A Prospective, Bicentric, Pilot Study
- ClinicalTrials.gov ID
- NCT02739880
- Acronym / sponsor ID
- INREG 1 / LOCAL/2016/PM-001
- Conditions
- Menopause, Dyspareunia
- Keywords
- Vaginal discomfort, Vaginal dryness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- Laboratoires Vivacy
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 6 Sep 2018 (actual)
- Study completion
- 6 Sep 2018 (actual)
- First posted
- 15 Apr 2016 (estimated)
- 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 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.
Detailed description
The secondary objectives of this study are to measure changes in the following between 0 and 8 weeks after injection:
- vaginal flora and Nugent score.
- vaginal pH.
- functional evolution via the VHI index by Gloria Bachman (state of the vaginal mucosa), pain / dyspareunia (visual analog scale) and the satisfaction concerning care viay the PGI-I questionnaire (Patient Global Impression and Improvement).
- Procollagen I and III gene expression (by PCR) and mitotic activity of the mucosa (Ki67 proliferation marker) based on biopsies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | Experimental | Device: DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid)The study population consists of postmenopausal patients (more than 2 years and less than 10 years) with a body mass index <35 with sexual disorders (dyspareunia) or vaginal discomfort associated with vaginal dryness. Intervention: Intra-mucosal Injections of Cross-linked Hyaluronic Acid |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- 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
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 |
|---|---|---|
| DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid)Also: Cross-linked Hyaluronic Acid, DESIRIAL®Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule The intervention is Intended for intra-mucosal injection in women for biostimulation / rehydration of the surface layers of the lining of the genital areas, vaginal hypotrophies and / or treatment of female sexual dysfunction related to subsidence G "spot or area of Gräfenberg ". Following disinfection and topical anesthesia (lidocaine gel), the vesitbule is injected using a multi-point technique. The optimal volume of DESIRIAL® to be used for injection into the vestibule is approximately 0.3 ml in total. | Device | The study population |
Primary outcome
The thickness of the vaginal mucosa on a histological section
Time frame: Day 0
The thickness of the vaginal mucosa on a histological section
Time frame: Week 8
15 secondary outcomes
Vaginal pH
Time frame: Day 0
Vaginal pH
Time frame: Week 8
Vaginal flora (on Pap smear)
Time frame: Day 0
Vaginal flora (on Pap smear)
Time frame: Week 8
Nugent score (on Pap smear)
Time frame: Day 0
Nugent score (on Pap smear)
Time frame: Week 8
PGI-I (Patient Global Impression and Improvement) Questionnaire
Time frame: Week 8
The Vaginal Health Index by Gloria Bachman
Time frame: Day 0
The Vaginal Health Index by Gloria Bachman
Time frame: Week 8
Pain (dyspareunia) by visual analog scale
Time frame: Day 0
Pain (dyspareunia) by visual analog scale
Time frame: Week 8
Measurement of collagen expression (procollagen I and III)
Time frame: Day 0
Measurement of collagen expression (procollagen I and III)
Time frame: Week 8
Level of Ki67 proliferation marker
Time frame: Day 0
Level of Ki67 proliferation marker
Time frame: Week 8
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 21 Nov 2025.
- Results publication: PubMed 34454465Berreni N, Salerno J, Chevalier T, Alonso S, Mares P. Evaluation of the effect of multipoint intra-mucosal vaginal injection of a specific cross-linked hyaluronic acid for vulvovaginal atrophy: a prospective bi-centric pilot study. BMC Womens Health. 2021 Aug 28;21(1):322. doi: 10.1186/s12905-021-01435-w.
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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.
Nicolas Berreni, MD study director
Centre Médical Karis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid) in people with Menopause and Dyspareunia, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
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 20 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 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The thickness of the vaginal mucosa on a histological section (time frame: Day 0). The study lists 2 primary outcomes in all. 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 NCT02739880, which also lists 1 linked publication.
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 21 Nov 2025.