Clinical Trials Directory

Trials / Completed

CompletedNCT05913479

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

HYDRAGYNE (MUCG234) - Evaluation of the Efficacy and Safety of Mucogye® Gel as a Moisturizer

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
34 (actual)
Sponsor
Biocodex · Industry
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEMucogyne GelAt 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)

Timeline

Start date
2023-10-10
Primary completion
2026-01-02
Completion
2026-01-02
First posted
2023-06-22
Last updated
2026-02-19

Locations

4 sites across 1 country: France

Source: ClinicalTrials.gov record NCT05913479. Inclusion in this directory is not an endorsement.

Evaluation of the Efficacy and Safety of Mucogye® Gel as a Moisturizer (NCT05913479) · Clinical Trials Directory