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Performance and Safety of MUCOGYNE® Ovule as a Moisturizer

NCT06282614 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-04-13

No results posted yet for this study

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 vulvovaginal dryness.

Conditions

  • Vaginal Dryness

Interventions

DEVICE

Mucogyne Ovule

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

Sponsors & Collaborators

  • Voisin Consulting Life Science (VCLS)

    collaborator UNKNOWN

  • Biocodex

    lead INDUSTRY

Principal Investigators

  • Oana BERNARD, MD · Chief Scientific Officer

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-11
Primary Completion
2025-02-14
Completion
2025-02-14

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06282614 on ClinicalTrials.gov