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

NCT ID: NCT05913479

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-10
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Mucogyne treatment

3 planned visits for each eligible patient:

• Screening/Baseline visit: V0 at Day 0. Patient receive a box of Mucogyne Gel.
• Phone call: V1 phone call at Day 10 ± 3
• End-of-study visit: V2 at Day 35 ± 3

Group Type: EXPERIMENTAL

Mucogyne Gel

Intervention Type: DEVICE

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)

Interventions

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)

Intervention Type: DEVICE

Eligibility Criteria

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.
• Subject with a known vaginal pathology (clinical diagnosis only) other than vaginal dryness/atrophy.
• Linked to previous or ongoing treatments:

• Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk.
• Subject suffering from systemic diseases and/or using concurrent therapy that may interfere with the evaluation of the study results.
• Subject undergoing a topical treatment on the test area or a systemic treatment: corticosteroids during the 2 previous weeks and during the study; retinoids and/or immunosuppressors during the 1,5 previous months and during the study; subject having started or changed her oral contraceptive or any other hormonal treatment during the one previous month.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Voisin Consulting Life Science (VCLS)

UNKNOWN

Sponsor Role: collaborator

Biocodex

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oana BERNARD, MD

Role: STUDY_DIRECTOR

Chief Scientific officer

Locations

Dr Paul Lefevre's medical office

Caen, , France

Site Status: RECRUITING

Dr Thierry KELLER's medical office

Colmar, , France

Site Status: RECRUITING

Dr Christiane ARMAND's medical office

Écully, , France

Site Status: RECRUITING

Sihame MOKHBAT's office

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Roxane NOEL

Role: CONTACT

r.noel@biocodex.fr

+33 3 44 86 75 79 ext. +33

Facility Contacts

Paul LEFEVRE, md

Role: primary

Thierry KELLER, MD

Role: primary

Christiane ARMAND, MD

Role: primary

Sihame MOKHBAT, midwife

Role: primary

Other Identifiers

2022-A02088-35

Identifier Type: OTHER

Identifier Source: secondary_id

MUCG234

Identifier Type: -

Identifier Source: org_study_id