Menu
Not yet recruiting NCT06585579

The Effect of Mucogyne® Ovule on Wound Healing (ORIGYNE)

No phase Interventional Cervicovaginitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mucogyne Ovule.
Who it may be relevant to
Registry conditions: Cervicovaginitis. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

ORIGYNE (MUCO232) - the Effect of Mucogyne® Ovule on Wound Healing

Overview

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.

Interventions

  • Device Mucogyne Ovule
    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)

Primary outcome measures

  • To confirm the performance of Mucogyne® ovule in wound healing promotion [Time frame: Day 0 to day 21(+10)]
Secondary outcome measures (6)
  • 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)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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,
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 3 centers
  • CHU Amiens-Picardie — Amiens
  • CHU Besançon — Besançon
  • Hôpital Nord Franche-Comté — Trévenans

Identifiers

NCT: NCT06585579 · MUCO232 · 2022-A02640-43

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗