Performance and Safety of MUCOGYNE® Ovule as a Moisturizer (MOVHYDA)

Biocodex

Status: Terminated

Conditions: Vaginal Dryness

Treatments: Device: Mucogyne Ovule

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06282614

MUCO245

2023-A02081-44 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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) : 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Mucogyne treatment

Experimental group

Description:

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

Treatment:

Device: Mucogyne Ovule