Vaginal DrynessHYDRAGYNENCT05913479
Evaluation of the Efficacy and Safety of Mucogye® Gel as a Moisturizer
A study testing Mucogyne Gel in people with Vaginal Dryness, run by Biocodex at 4 sites in France.
Trial summary
The aim of this post-Market Clinical Follow-up (PMCF) study for a class IIb medical device is to confirm th efficacy and safety of Mucogyne Gel as a moisturizer in women with vaginal dryness irrespective of the cause; when used in accordance with its approved labelling. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Dryness
- What is being tested?
- Mucogyne Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 4 sitesFrance
- Study dates
- 10 Oct 2023to 2 Jan 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with the following conditions:
- ≥ 18 years of age at inclusion with vaginal dryness, irrespective of the cause (which may or may not be accompanied by irritation of the vulva, discomfort, or itchiness).
- Having a Vaginal Health Index Score (VHIS) <15 associated to pain and/or dyspareunia feeling.
- Subject agrees to not use any lubricant, local estrogens, or other vaginal product during the study.
- Subject agrees to not modify their intimate hygiene products.
- Able to understand and sign the informed consent form for study enrolment.
- Subject able to comply with study requirements, as defined in the protocol.
- Subject affiliated to a health social security system.
Who cannot join
- Women with the following conditions:
- General:
- Pregnancy (subject of childbearing potential must not be pregnant and must agree to avoid pregnancy during the study by using an effective birth control method from at least one month before D0 (V0) and throughout the duration of the study).
- Participating at the same time in another interventional trial within the four previous weeks and during the study period, being in an exclusion period for a previous study.
- Deprived of freedom by administrative or legal decision or under guardianship.
- Subject in a social or sanitary establishment.
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- Subject suspected to be non-compliant according to the investigator's judgment.
- Subject in an emergency situation.
- Linked to subject's status:
- Known hypersensitivity to one of MUCOGYNE® Gel components.
- Subject with a known vaginal pathology (clinical diagnosis only) other than vaginal dryness/atrophy.
- Linked to previous or ongoing treatments:
- Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk.
- Subject suffering from systemic diseases and/or using concurrent therapy that may interfere with the evaluation of the study results.
- Subject undergoing a topical treatment on the test area or a systemic treatment: corticosteroids during the 2 previous weeks and during the study; retinoids and/or immunosuppressors during the 1,5 previous months and during the study; subject having started or changed her oral contraceptive or any other hormonal treatment during the one previous month.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Dr Paul Lefevre's medical office
Caen, 14000
Dr Thierry KELLER's medical office
Colmar, 68000
Dr Christiane ARMAND's medical office
Écully, 69130
Sihame MOKHBAT's office
Paris, 75018
About this study
Official title: HYDRAGYNE (MUCG234) - Evaluation of the Efficacy and Safety of Mucogye® Gel as a Moisturizer
The aim of this post-Market Clinical Follow-up (PMCF) study for a class IIb medical device is to confirm th efficacy and safety of Mucogyne Gel as a moisturizer in women with vaginal dryness irrespective of the cause; when used in accordance with its approved labelling.
- Conditions
- Vaginal Dryness
- Being tested
- Mucogyne Gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mucogyne GelDevice
At inclusion visit (V0), the Investigator will ask the subject to apply MUCOGYNE® Gel as described in the Instructions For Use, i.e., internally, one application 2 to 3 times a week until symptoms improve during 5 weeks (D35 +/- 3)
| Study group | Role | What they receive |
|---|---|---|
| Mucogyne treatment | Experimental | 3 planned visits for each eligible patient:
* Screening/Baseline visit: V0 at Day 0. Patient receive a box of Mucogyne Gel.
* Phone call: V1 phone call at Day 10 ± 3
* End-of-study visit: V2 at Day 35 ± 3 Receives: Device: Mucogyne Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the efficacy of MUCOGYNE® Gel intra vaginal applications on subjects' vaginal dryness irrespective of the cause over a 35-day period of use.
Primary efficacy criterion: Clinical scoring, by the investigator, of the Vaginal Health Index Score (VHIS), including evaluation of elasticity, fluid volume, pH, epithelial integrity, and moisture.
Measured: Day 0 to Day 35 +/- 3
Secondary outcomes (6)
Assessment of the local performance of MUCOGYNE® Gel in reducing vulva irritation
Secondary efficacy criteria
- Auto-evaluation, by the subjects, of pain and/or dyspareunia on Visual Analogical Scales (VAS) from 0 to 10
Measured: Day 0 to Day 35 +/- 3
Assessment of the local performance of MUCOGYNE® Gel in reducing vulvo-vaginal dryness
Secondary efficacy criteria
- Clinical scoring of vulvo-vaginal dryness by the Investigator on a Visual Analogical Scale from 0 to 10
Measured: Day 0 to Day 35 +/- 3
Assessment by investigator of changes in patient's clinical status
Secondary efficacy criteria
- Completion of the CGI-I (Clinical Global Impressions-Improvement) by the Investigator.
Measured: Day 0 to Day 35 +/- 3
Assessment of changes in patient's clinical status
Secondary efficacy criteria
- Completion of the Patients' Global Impression of Change (PGIC) Scale to assess the changes perceived by the patient following the treatment taken.
Measured: Day 0 to Day 35 +/- 3
Assessment of the patient's satisfaction
Secondary efficacy criteria
- Completion of the intra vaginal treatment satisfaction questionnaire (Likert questionnaire) to assess the level of satisfaction of the treatment on the vaginal symptoms.
Measured: Day 0 to Day 35 +/- 3
Assessment of the patient's sexual function
Secondary efficacy criteria
- Completion of the self-reported FSFI (Female Sexual Function Index) to investigate sexual function (for women having sexual relations).
Measured: Day 0 to Day 35 +/- 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start10 Oct 2023
- Primary completion2 Jan 2026
- Study completion2 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal DrynessStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multicenter (France), open label without comparator study
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocodex
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Voisin Consulting Life Science (VCLS)
- Responsible party
- Sponsor
- Investigators
- Oana BERNARD, MD, Study director, Chief Scientific officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913479
- Sponsor's protocol ID
- MUCG234
- Other IDs
- 2022-A02088-35
- Acronym
- HYDRAGYNE
- Status last verified
- Feb 2026
- First submitted
- 31 May 2023
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYDRAGYNE (MUCG234) - Evaluation of the Efficacy and Safety of Mucogye® Gel as a Moisturizer
- ClinicalTrials.gov ID
- NCT05913479
- Acronym / sponsor ID
- HYDRAGYNE / MUCG234
- Conditions
- Vaginal Dryness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- BiocodexIndustry (pharma, biotech, devices)
- Collaborators
- Voisin Consulting Life Science (VCLS)
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 2 Jan 2026 (actual)
- Study completion
- 2 Jan 2026 (actual)
- First posted
- 22 Jun 2023 (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 aim of this post-Market Clinical Follow-up (PMCF) study for a class IIb medical device is to confirm th efficacy and safety of Mucogyne Gel as a moisturizer in women with vaginal dryness irrespective of the cause; when used in accordance with its approved labelling.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multicenter (France), open label without comparator study
| Arm | Type | Receives |
|---|---|---|
| Mucogyne treatment | Experimental | Device: Mucogyne Gel3 planned visits for each eligible patient: * Screening/Baseline visit: V0 at Day 0. Patient receive a box of Mucogyne Gel. * Phone call: V1 phone call at Day 10 ± 3 * End-of-study visit: V2 at Day 35 ± 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 18 years of age at inclusion with vaginal dryness, irrespective of the cause (which may or may not be accompanied by irritation of the vulva, discomfort, or itchiness).
- Having a Vaginal Health Index Score (VHIS) <15 associated to pain and/or dyspareunia feeling.
- Subject agrees to not use any lubricant, local estrogens, or other vaginal product during the study.
- Subject agrees to not modify their intimate hygiene products.
- Able to understand and sign the informed consent form for study enrolment.
Key exclusion criteria (15 listed)
- General:
- Linked to subject's status:
- Linked to previous or ongoing treatments:
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 |
|---|---|---|
| Mucogyne GelAt inclusion visit (V0), the Investigator will ask the subject to apply MUCOGYNE® Gel as described in the Instructions For Use, i.e., internally, one application 2 to 3 times a week until symptoms improve during 5 weeks (D35 +/- 3) | Device | Mucogyne treatment |
Primary outcome
Assessment of the efficacy of MUCOGYNE® Gel intra vaginal applications on subjects' vaginal dryness irrespective of the cause over a 35-day period of use.
Time frame: Day 0 to Day 35 +/- 3
Primary efficacy criterion: Clinical scoring, by the investigator, of the Vaginal Health Index Score (VHIS), including evaluation of elasticity, fluid volume, pH, epithelial integrity, and moisture.
6 secondary outcomes
Assessment of the local performance of MUCOGYNE® Gel in reducing vulva irritation
Time frame: Day 0 to Day 35 +/- 3
Assessment of the local performance of MUCOGYNE® Gel in reducing vulvo-vaginal dryness
Time frame: Day 0 to Day 35 +/- 3
Assessment by investigator of changes in patient's clinical status
Time frame: Day 0 to Day 35 +/- 3
Assessment of changes in patient's clinical status
Time frame: Day 0 to Day 35 +/- 3
Assessment of the patient's satisfaction
Time frame: Day 0 to Day 35 +/- 3
Assessment of the patient's sexual function
Time frame: Day 0 to Day 35 +/- 3
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 19 Feb 2026.
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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.
Oana BERNARD, MD study director
Chief Scientific officer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mucogyne Gel in people with Vaginal Dryness, run by Biocodex at 4 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 8 inclusion and 15 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 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Assessment of the efficacy of MUCOGYNE® Gel intra vaginal applications on subjects' vaginal dryness irrespective of the cause over a 35-day period of use. (time frame: Day 0 to Day 35 +/- 3). 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 19 Feb 2026.