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Vaginal DrynessMOVHYDANCT06282614

Performance and Safety of MUCOGYNE® Ovule as a Moisturizer

A study testing Mucogyne Ovule in people with Vaginal Dryness, run by Biocodex at 3 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The aim of this post-Market Clinical Follow-up (PMCF) study is to confirm the efficacy and safety of MUCOGYNE® Ovule in the maintainance of natural moisture of the vulvovaginal mucosa and in the compensation for any natural secretions deficiencies, when used in accordance with its approved labeling, in the context of… 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 Ovule
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
3 sitesFrance
Study dates
11 Apr 2024to 14 Feb 2025
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) : women who suffer pain during sexual intercourse, women taking the mini pill, mothers during breastfeeding, menopausal women and women taking anti-acne treatment.
  • Having a Vaginal Health Index Score (VHIS) <15 associated to pain and/or dyspareunia feeling.
  • If the patient has reproductive potential, she must be willing to use effective method of contraception (oral contraceptive, intrauterine device, subcutaneous contraceptive implant, vaginal ring, and condom).
  • Patient agrees to not use any local oestrogens, or other vaginal product during the study
  • Patient agrees to not modify their intimate hygiene and lubricant products
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  • Patient able to understand and sign the informed consent form before beginning any study procedure
  • Patient able to comply with study requirements, as defined in the protocol.
  • Patient affiliated to a health social security system.

Who cannot join

  • Women with the following conditions:
  • General criteria:
  • Pregnant women (patient 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 (V1) and throughout the duration of the study)
  • Patient 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
  • Patient deprived of freedom by administrative or legal decision or under guardianship
  • Patient in a social or sanitary establishment
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  • Patient suspected to be non-compliant according to the investigator's judgment
  • Patient in an emergency situation
  • Criteria related to patient's status:
  • Patient with known hypersensitivity to one of MUCOGYNE® Ovule components
  • Patient with a known vaginal pathology (clinical diagnosis only) other than vaginal dryness/atrophy
  • Criteria related to previous or ongoing treatments:
  • Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk
  • Patient suffering from systemic diseases and/or using concurrent therapy that may interfere with the evaluation of the study results
  • Patient undergoing a topical treatment on the test area or a systemic treatment such as:
  • corticosteroids during the 2 previous weeks and during the study
  • retinoids and/or immunosuppressors during the 1.5 previous months and during the study
  • Patient having started or changed her oral contraceptive or any other hormonal treatment during the three previous months

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • JEAN Christian's medical office

    Nogent-sur-Marne, 94130

  • Dr Ramez GHADRI's medical office

    Orléans, France, 45100

  • Dr Raïssa APERANO-MAS's medical office

    Rennes, 35000

Other trials in France

About this study

Official title: MOVHYDA (MUCO245) - Performance and Safety of MUCOGYNE® Ovule as a Moisturizer

The aim of this post-Market Clinical Follow-up (PMCF) study is to confirm the efficacy and safety of MUCOGYNE® Ovule in the maintainance of natural moisture of the vulvovaginal mucosa and in the compensation for any natural secretions deficiencies, when used in accordance with its approved labeling, in the context of vulvovaginal dryness.

Conditions
Vaginal Dryness
Being tested
Mucogyne Ovule

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mucogyne OvuleDevice

    At inclusion visit (V0), the Investigator will ask the subject to use MUCOGYNE® Ovule 2 times a week until symptoms improve during 5 weeks (D35± 3) preferably at bedtime

Study groups in NCT06282614
Study groupRoleWhat they receive
Mucogyne treatmentExperimental2 planned visits for each eligible patient : * Screening/Baseline visit : V1 at Day 0. Patient receive Mucogyne Ovule. * End-of-study visit : V2 at Day 35 ± 3
Receives: Device: Mucogyne Ovule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of the efficacy of MUCOGYNE® Ovule 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. The minimum score is 5 and the maximum score is 25. If VHIS <15, the vagina is considered atrophic.

    Measured: Day 0 to Day 35 ± 3

Secondary outcomes (11)

  1. Assessment of the local performance of MUCOGYNE® Ovule in reducing vulva irritation

    Secondary efficacy criteria : Auto-evaluation, by the subjects, of vulva irritation on Visual Analogical Scales (VAS) from 0 to 10

    Measured: Day 0 to Day 35 ± 3

  2. Assessment of the local performance of MUCOGYNE® Ovule in reducing vulvo-vaginal discomfort

    Secondary efficacy criteria : Auto-evaluation, by the subjects, of discomfort on Visual Analogical Scales (VAS) from 0 to 10

    Measured: Day 0 to Day 35 ± 3

  3. Assessment of the local performance of MUCOGYNE® Ovule in reducing itching

    Secondary efficacy criteria : Auto-evaluation, by the subjects, of itching on Visual Analogical Scales (VAS) from 0 to 10

    Measured: Day 0 to Day 35 ± 3

  4. Assessment of the local performance of MUCOGYNE® Ovule in reducing pain and/or dyspareunia related to vaginal dryness

    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

  5. 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). The minimum score is 2 and the maximum score is 36. An alteration in sexuality is a score less than or equal to 26,55.

    Measured: Day 0 to Day 35 ± 3

  6. 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. Two questions with 5 possible answers :
    • 1 : Strongly agree
    • 2 : Agree
    • 3 : Neither
    • 4 : Disagree
    • 5 : Strongly disagree

    Measured: Day 0 to Day 35 ± 3

  7. 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 from 1 to 7. An improvement is a score from 1 to 3 whereas a deterioration is a score of 5 to 7. A score of 4 means stability.

    Measured: Day 0 to Day 35 ± 3

  8. Assessment by investigator of changes in patient's clinical status

    Secondary efficacy criteria :Completion of the Clinical Global Impressions-Improvement (CGI-I) by the investigator to assess the changes following the treatment taken from 1 to 7. An improvement is a score from 1 to 3 whereas a deterioration is a score of 5 to 7. A score of 4 means stability.

    Measured: Day 0 to Day 35 ± 3

  9. Assessment of the safety of MUCOGYNE® Ovule

    Secondary efficacy criteria : Reporting of number, nature and characteristics of any adverse event : incidence, seriousness, severity, resolution.

    Measured: Day 0 to Day 35 ± 3

  10. Assessment of the device deficiencies of MUCOGYNE® Ovule

    Secondary efficacy criteria : Reporting of Device deficiencies: type of deficiency, batch number, action taken, consequence of deficiency.

    Measured: Day 0 to Day 35 ± 3

  11. Assessment of the usability of MUCOGYNE® Ovule

    Secondary efficacy criteria :

    • Completion of the usability question by the patient. There are 4 possible answers :
    • Very easy
    • Easy
    • Difficult
    • Very Difficult

    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.

  1. First posted28 Feb 2024
  2. Study start11 Apr 2024
  3. Primary completion14 Feb 2025
  4. Study completion14 Feb 2025

Why it stopped: Early efficacy at interim analysis.

Resources

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
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06282614
Sponsor's protocol ID
MUCO245
Other IDs
2023-A02081-44
Acronym
MOVHYDA
Status last verified
Apr 2025
First submitted
1 Feb 2024
Last updated
13 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ghadri R, Aperano-Mas R, Jean C, Keller T, Noel R, Houamel D. Performance and safety of a moisturising hyaluronic acid-based ovule in alleviating vaginal dryness and dyspareunia: a prospective multicentre study. Gynecol Endocrinol. 2026 Dec 31;42(1):2721098. doi: 10.1080/09513590.2026.2721098. Epub 2026 Aug 26.

    PubMed 42643155

Questions about this trial

What is this clinical trial studying?

A study testing Mucogyne Ovule in people with Vaginal Dryness, run by Biocodex at 3 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 9 inclusion and 18 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: stopped early, as of the sponsor's last update on 13 Apr 2025. 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. 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 was stopped early (reason given: Early efficacy at interim analysis.). Results are not available in the source record.

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® Ovule 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?

On the ClinicalTrials.gov record for NCT06282614, 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 13 Apr 2025.

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