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

Biocodex

Status: Completed

Conditions: Vaginal Dryness

Treatments: Device: Mucogyne Gel

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05913479

MUCG234

2022-A02088-35 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 50 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).
• 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Mucogyne treatment

Experimental group

Description:

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

Treatment:

Device: Mucogyne Gel