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

NCT05913479 | Completed

• 2 other identifiers: MUCG2342022-A02088-35
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Assessment of the efficacy of MUCOGYNE® Gel intra vaginal applications on subjects' vaginal dryness irrespective of the cause over a 35-day period of use.

  Primary efficacy criterion: Clinical scoring, by the investigator, of the Vaginal Health Index Score (VHIS), including evaluation of elasticity, fluid volume, pH, epithelial integrity, and moisture.

  Day 0 to Day 35 +/- 3

Secondary Outcomes (6)

• Assessment of the local performance of MUCOGYNE® Gel in reducing vulva irritation

  Day 0 to Day 35 +/- 3

• Assessment of the local performance of MUCOGYNE® Gel in reducing vulvo-vaginal dryness

  Day 0 to Day 35 +/- 3

• Assessment by investigator of changes in patient's clinical status

  Day 0 to Day 35 +/- 3

• Assessment of changes in patient's clinical status

  Day 0 to Day 35 +/- 3

• Assessment of the patient's satisfaction

  Day 0 to Day 35 +/- 3

Study Arms (1)

Mucogyne treatment

EXPERIMENTAL

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

Device: Mucogyne Gel

Interventions

Mucogyne Gel 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)

Mucogyne treatment

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with the following conditions:
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Biocodex: lead
• Voisin Consulting Life Science (VCLS): collaborator

Study Sites (4)

Dr Paul Lefevre's medical office

Caen, 14000, France

Location

Dr Thierry KELLER's medical office

Colmar, 68000, France

Location

Dr Christiane ARMAND's medical office

Écully, 69130, France

Location

Sihame MOKHBAT's office

Paris, 75018, France

Location

Study Officials

• Oana BERNARD, MD

  Chief Scientific officer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter (France), open label without comparator study

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 22, 2023
• Study Start: October 10, 2023
• Primary Completion: January 2, 2026
• Study Completion: January 2, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

FR (4)