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Evaluation of the Efficacy and Safety of Mucogye® Gel as a Moisturizer

NCT05913479 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-02-19

No results posted yet for this study

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.

Conditions

  • Vaginal Dryness

Interventions

DEVICE

Mucogyne Gel

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)

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
2023-10-10
Primary Completion
2026-01-02
Completion
2026-01-02

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 NCT05913479 on ClinicalTrials.gov