CervicovaginitisORIGYNENCT06585579
The Effect of Mucogyne® Ovule on Wound Healing (ORIGYNE)
A study testing Mucogyne Ovule in people with Cervicovaginitis, run by Biocodex at 3 sites in France.
Trial summary
This clinical investigation is a post-market clinical follow-up performed to confirm the performance and safety of the Mucogyne® ovule medical device in promoting the process of wound healing, when used in accordance with its approved labelling, in the context of local cervicovaginal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervicovaginitis
- 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
- 144 participants
- Where
- 3 sitesFrance
- Study dates
- Oct 2024to Nov 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
- Adult women who had undergone localized surgery (laser or loop electrosurgical excision procedure (LEEP) conization) for cervical or vaginal dysplasia,
- Is able to understand the study related information and to give a written informed consent,
- Has signed the informed consent form before beginning any study procedure,
- Has no condition that may interfere with the study assessments,
- Agrees not to use other vaginal products than those planned in the study protocol, during participation in the study,
- Is able to comply with protocol requirements and respect the conditions of the study,
- Affiliated to the Social Security system.
Who cannot join
- Previous vaginal surgery within the year preceding the inclusion in the study,
- Known hypersensitivity to any of the medical device ingredients,
- Patient with local infectious lesions in the area to be repaired.
- Patient who had used anti-inflammatory drugs (regular intake) or anticoagulants during the month preceding the inclusion in the study,
- Patient who had a history of diseases known to disturb wound healing (e.g. systemic, heart, and renal diseases, coagulation disorders, immunedeficiency, connective tissue disorders, diabetes, anemia (with hemoglobin level < 9 g/dl) and hemophilia),
- Immunosuppressive treatment,
Show all 9Show fewer
- Heavy cigarettes smoker (i.e., more than 15 cigarettes or equivalent/day, according to the patient and their documented records),
- Patients under judicial protection or under guardianship and patients deprived of freedom,
- Has any other severe chronic or acute medical or psychiatric condition that in the judgment of the Investigator, could interfere with the study assessments.
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Amiens-Picardie
Amiens, 80054
Arthur FOULON, MD
CHU Besançon
Besançon, 25000
Rajeev RAMANAH, MD
Hôpital Nord Franche-Comté
Trévenans, 90400
Catherine GAY
About this study
Official title: ORIGYNE (MUCO232) - the Effect of Mucogyne® Ovule on Wound Healing
This clinical investigation is a post-market clinical follow-up performed to confirm the performance and safety of the Mucogyne® ovule medical device in promoting the process of wound healing, when used in accordance with its approved labelling, in the context of local cervicovaginal surgery.
- Conditions
- Cervicovaginitis
- 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
In Mucogyne group, patient will receive 2 boxes of Mucogyne® ovule. 24 hours after intervention, the patient will apply Mucogyne® ovule, 1 ovule per day for 10 days, to be repeated as needed (for practices' homogenisation, after the 10th day, it is recommended to apply one ovule every second day, until EOS visit)
| Study group | Role | What they receive |
|---|---|---|
| Mucogyne group | Experimental | For each eligible patient, the study will consist of:
* A Screening/Inclusion visit
* A treatment period (application of the medical device Mucogyne® ovule) for 21 days
* An End Of Study visit (Day 21 (+10) after surgery) Receives: Device: Mucogyne Ovule |
| Control group | No intervention | standard of care e.i no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To confirm the performance of Mucogyne® ovule in wound healing promotion
The primary endpoint is a composite endpoint derived with the following criteria:
- Inflammation evaluated with a 5-point scale (none, mild, moderate, severe, very severe) and not assessed,
- Edema evaluated with a 5-point scale (none, mild, moderate, severe, very severe) and not assessed,
- Abrasion evaluated with a 5-point scale (none, mild, moderate, severe, very severe) and not assessed,
- Coalescence evaluated with a 3-point scale (none, partial, total) and not assessed.
- Opening of the cervix (only for cervical wound) evaluated with a 4-point scale (closed, slightly open, open, gaping) and not assessed.
Measured: Day 0 to day 21(+10)
Secondary outcomes (6)
To assess the aspect of the epithelium 3(+1) weeks after surgery
Criteria assessing the aspect of the epithelium (such as presence of mucosa, stroma, presence and quality of mucus, opening of the cervix, presence or absence of inflammation, edema, vulvo-vaginal abrasions, coalescence, adherence, leucorrhoea and bleeding at contact)
Measured: Day 0 to day 21(+10)
To assess the performance of Mucogyne® ovule in symptoms relief
Vaginal symptoms (dryness, itching, burning, discharge) will be assessed by the patient using a 4-point scale (1 = absent, 2 = mild, 3 = moderate, 4 = severe) at 3 (+1) weeks after surgery
Measured: Day 0 to day 21(+10)
To assess the performance of Mucogyne® ovule in reducing postoperative side effects and complications
Postoperative side-effects (i.e. postoperative bleeding, infection and impairment of daily activities, etc.) will be assessed using a questionnaire. For the assessment of hemorrhage, the amounts of bleeding will be checked with a pictorial blood assessment chart.
Measured: Day 0 to day 21(+10)
To assess change in clinical status
Change in clinical status will be assessed by the Investigator using Clinical Global Impressions scale, (CGI) at 3(+1) weeks after surgery
Measured: Day 0 to day 21(+10)
To assess compliance with the Medical Device use
Compliance with the Medical Device use will be assessed by number of days of use
Measured: Day 0 to day 21(+10)
To assess the safety of Mucogyne® ovule
Number, nature and characteristics of any incident reported: incidence, seriousness, severity, resolution
Measured: Day 0 to day 21(+10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CervicovaginitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, multicenter, randomized, controlled study
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocodex
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oana BERNARD, MD, Study director, Chief Scientific Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585579
- Sponsor's protocol ID
- MUCO232
- Other IDs
- 2022-A02640-43
- Acronym
- ORIGYNE
- Status last verified
- Sep 2024
- First submitted
- 3 Sep 2024
- Last updated
- 5 Sep 2024
- 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 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ORIGYNE (MUCO232) - the Effect of Mucogyne® Ovule on Wound Healing
- ClinicalTrials.gov ID
- NCT06585579
- Acronym / sponsor ID
- ORIGYNE / MUCO232
- Conditions
- Cervicovaginitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- BiocodexIndustry (pharma, biotech, devices)
- Study start
- Oct 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 5 Sep 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.
This clinical investigation is a post-market clinical follow-up performed to confirm the performance and safety of the Mucogyne® ovule medical device in promoting the process of wound healing, when used in accordance with its approved labelling, in the context of local cervicovaginal surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, multicenter, randomized, controlled study
| Arm | Type | Receives |
|---|---|---|
| Mucogyne group | Experimental | Device: Mucogyne OvuleFor each eligible patient, the study will consist of: * A Screening/Inclusion visit * A treatment period (application of the medical device Mucogyne® ovule) for 21 days * An End Of Study visit (Day 21 (+10) after surgery) |
| Control group | No intervention | –standard of care e.i no treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult women who had undergone localized surgery (laser or loop electrosurgical excision procedure (LEEP) conization) for cervical or vaginal dysplasia,
- Is able to understand the study related information and to give a written informed consent,
- Has signed the informed consent form before beginning any study procedure,
- Has no condition that may interfere with the study assessments,
- Agrees not to use other vaginal products than those planned in the study protocol, during participation in the study,
Key exclusion criteria (9 listed)
- Previous vaginal surgery within the year preceding the inclusion in the study,
- Known hypersensitivity to any of the medical device ingredients,
- Patient with local infectious lesions in the area to be repaired.
- Patient who had used anti-inflammatory drugs (regular intake) or anticoagulants during the month preceding the inclusion in the study,
- Patient who had a history of diseases known to disturb wound healing (e.g. systemic, heart, and renal diseases, coagulation disorders, immunedeficiency, connective tissue disorders, diabetes, anemia (with hemoglobin level < 9 g/dl) and hemophilia),
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 OvuleIn Mucogyne group, patient will receive 2 boxes of Mucogyne® ovule. 24 hours after intervention, the patient will apply Mucogyne® ovule, 1 ovule per day for 10 days, to be repeated as needed (for practices' homogenisation, after the 10th day, it is recommended to apply one ovule every second day, until EOS visit) | Device | Mucogyne group |
Primary outcome
To confirm the performance of Mucogyne® ovule in wound healing promotion
Time frame: Day 0 to day 21(+10)
The primary endpoint is a composite endpoint derived with the following criteria: * Inflammation evaluated with a 5-point scale (none, mild, moderate, severe, very severe) and not assessed, * Edema evaluated with a 5-point scale (none, mild, moderate, severe, very severe) and not assessed, * Abrasion evaluated with a 5-point scale (none, mild, moderate, severe, very severe) and not assessed, * Coalescence evaluated with a 3-point scale (none, partial, total) and not assessed. * Opening of the cervix (only for cervical wound) evaluated with a 4-point scale (closed, slightly open, open, gaping) and not assessed.
6 secondary outcomes
To assess the aspect of the epithelium 3(+1) weeks after surgery
Time frame: Day 0 to day 21(+10)
To assess the performance of Mucogyne® ovule in symptoms relief
Time frame: Day 0 to day 21(+10)
To assess the performance of Mucogyne® ovule in reducing postoperative side effects and complications
Time frame: Day 0 to day 21(+10)
To assess change in clinical status
Time frame: Day 0 to day 21(+10)
To assess compliance with the Medical Device use
Time frame: Day 0 to day 21(+10)
To assess the safety of Mucogyne® ovule
Time frame: Day 0 to day 21(+10)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mucogyne Ovule in people with Cervicovaginitis, 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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 5 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gaëlle MARIAULE (+33 3 44 86 75 97, g.mariaule@biocodex.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To confirm the performance of Mucogyne® ovule in wound healing promotion (time frame: Day 0 to day 21(+10)). 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 5 Sep 2024.