Performance and Safety of MUCOGYNE® Ovule as a Moisturizer

NCT ID: NCT06282614

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-11
• Study Completion Date: 2025-02-14

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

Study Design

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

Study Groups

Mucogyne treatment

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

Group Type: EXPERIMENTAL

Mucogyne Ovule

Intervention Type: 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

Interventions

Mucogyne Ovule

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

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) : women who suffer pain during sexual intercourse, women taking the mini pill, mothers during breastfeeding, menopausal women and women taking anti-acne treatment.
• 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.

Exclusion Criteria

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 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
• 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
• retinoids and/or immunosuppressors during the 1.5 previous months and during the study
• Patient having started or changed her oral contraceptive or any other hormonal treatment during the three previous months

• 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 Ramez GHADRI's medical office

Orléans, France, France

JEAN Christian's medical office

Nogent-sur-Marne, , France

Dr Raïssa APERANO-MAS's medical office

Rennes, , France

Countries

France

Other Identifiers

2023-A02081-44

Identifier Type: OTHER

Identifier Source: secondary_id

MUCO245

Identifier Type: -

Identifier Source: org_study_id