Performance and Safety of MUCOGYNE® Ovule as a Moisturizer

NCT06282614 | Terminated

• 2 other identifiers: MUCO2452023-A02081-44
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

Brief Summary

The aim of this post-Market Clinical Follow-up (PMCF) study is to confirm the efficacy and safety of MUCOGYNE® Ovule in the maintainance of natural moisture of the vulvovaginal mucosa and in the compensation for any natural secretions deficiencies, when used in accordance with its approved labeling, in the context of vulvovaginal dryness.

Conditions

Vaginal Dryness

Outcome Measures

Primary Outcomes (1)

• Assessment of the efficacy of MUCOGYNE® Ovule 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. The minimum score is 5 and the maximum score is 25. If VHIS \<15, the vagina is considered atrophic.

  Day 0 to Day 35 ± 3

Secondary Outcomes (11)

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

  Day 0 to Day 35 ± 3

• Assessment of the local performance of MUCOGYNE® Ovule in reducing vulvo-vaginal discomfort

  Day 0 to Day 35 ± 3

• Assessment of the local performance of MUCOGYNE® Ovule in reducing itching

  Day 0 to Day 35 ± 3

• Assessment of the local performance of MUCOGYNE® Ovule in reducing pain and/or dyspareunia related to vaginal dryness

  Day 0 to Day 35 ± 3

• Assessment of the patient's sexual function

  Day 0 to Day 35 ± 3

Study Arms (1)

Mucogyne treatment

EXPERIMENTAL

2 planned visits for each eligible patient : * Screening/Baseline visit : V1 at Day 0. Patient receive Mucogyne Ovule. * End-of-study visit : V2 at Day 35 ± 3

Device: Mucogyne Ovule

Interventions

Mucogyne Ovule DEVICE

At inclusion visit (V0), the Investigator will ask the subject to use MUCOGYNE® Ovule 2 times a week until symptoms improve during 5 weeks (D35± 3) preferably at bedtime

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.
• If the patient has reproductive potential, she must be willing to use effective method of contraception (oral contraceptive, intrauterine device, subcutaneous contraceptive implant, vaginal ring, and condom).
• Patient agrees to not use any local oestrogens, or other vaginal product during the study
• Patient agrees to not modify their intimate hygiene and lubricant products
• Patient able to understand and sign the informed consent form before beginning any study procedure
• Patient able to comply with study requirements, as defined in the protocol.
• Patient affiliated to a health social security system.

You may not qualify if:

• Women with the following conditions:
• General criteria:
• Pregnant women (patient 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 (V1) and throughout the duration of the study)
• Patient deprived of freedom by administrative or legal decision or under guardianship
• Patient in a social or sanitary establishment
• Patient suspected to be non-compliant according to the investigator's judgment
• Patient in an emergency situation
• Criteria related to patient's status:
• Patient with known hypersensitivity to one of MUCOGYNE® Ovule components
• Patient with a known vaginal pathology (clinical diagnosis only) other than vaginal dryness/atrophy
• Criteria related to previous or ongoing treatments:
• Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk
• Patient suffering from systemic diseases and/or using concurrent therapy that may interfere with the evaluation of the study results
• Patient undergoing a topical treatment on the test area or a systemic treatment such as:
• corticosteroids during the 2 previous weeks and during the study

Sponsors & Collaborators

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

Study Sites (3)

Dr Ramez GHADRI's medical office

Orléans, France, 45100, France

Location

JEAN Christian's medical office

Nogent-sur-Marne, 94130, France

Location

Dr Raïssa APERANO-MAS's medical office

Rennes, 35000, 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: February 1, 2024
• First Posted: February 28, 2024
• Study Start: April 11, 2024
• Primary Completion: February 14, 2025
• Study Completion: February 14, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)