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Evaluation of the Efficacy and Safety of Mucogye® Gel as a Moisturizer | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT05913479•Biocodex

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Women with the following conditions:
•≥ 18 years of age at inclusion with vaginal dryness, irrespective of the cause (which may or may not be accompanied by irritation of the vulva, discomfort, or itchiness).
•Having a Vaginal Health Index Score (VHIS) \<15 associated to pain and/or dyspareunia feeling.
•Subject agrees to not use any lubricant, local estrogens, or other vaginal product during the study.
•Subject agrees to not modify their intimate hygiene products.
•Able to understand and sign the informed consent form for study enrolment.
•Subject able to comply with study requirements, as defined in the protocol.
•Subject affiliated to a health social security system.

Exclusion Criteria

•Women with the following conditions:
•General:
•* Pregnancy (subject of childbearing potential must not be pregnant and must agree to avoid pregnancy during the study by using an effective birth control method from at least one month before D0 (V0) and throughout the duration of the study).
•* Participating at the same time in another interventional trial within the four previous weeks and during the study period, being in an exclusion period for a previous study.
•* Deprived of freedom by administrative or legal decision or under guardianship.
•* Subject in a social or sanitary establishment.
•* Subject suspected to be non-compliant according to the investigator's judgment.
•* Subject in an emergency situation.
•Linked to subject's status:
•* Known hypersensitivity to one of MUCOGYNE® Gel components.
+5 more criteria

Locations (4)

Dr Paul Lefevre's medical office

Caen, France

Dr Thierry KELLER's medical office

Colmar, France

Dr Christiane ARMAND's medical office

Écully, France

Sihame MOKHBAT's office

Paris, France

Key Dates

Start Date

October 10, 2023

Primary Completion Date

January 2, 2026

Completion Date

January 2, 2026

Last Updated

February 19, 2026

Enrollment

ACTUAL participants

Conditions

Vaginal Dryness

Interventions

Mucogyne Gel

DEVICE

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TERMINATEDNA

Performance and Safety of MUCOGYNE® Ovule as a Moisturizer

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COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety of Vaginal Radiofrequency for Vulvovaginal Atrophy in Breast Cancer Patients

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