Performance and Safety of MUCOGYNE® Ovule as a Moisturizer

Last updated: April 10, 2025
Sponsor: Biocodex
Overall Status: Terminated

Phase

N/A

Condition

Vaginitis

Vaginal Atrophy

Treatment

Mucogyne Ovule

Clinical Study ID

NCT06282614
MUCO245
2023-A02081-44
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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, oritchiness) : women who suffer pain during sexual intercourse, women taking the minipill, mothers during breastfeeding, menopausal women and women taking anti-acnetreatment.

  • Having a Vaginal Health Index Score (VHIS) <15 associated to pain and/or dyspareuniafeeling.

  • If the patient has reproductive potential, she must be willing to use effectivemethod of contraception (oral contraceptive, intrauterine device, subcutaneouscontraceptive implant, vaginal ring, and condom).

  • Patient agrees to not use any local oestrogens, or other vaginal product during thestudy

  • Patient agrees to not modify their intimate hygiene and lubricant products

  • Patient able to understand and sign the informed consent form before beginning anystudy procedure

  • Patient able to comply with study requirements, as defined in the protocol.

  • Patient affiliated to a health social security system.

Exclusion

Exclusion Criteria:

Women with the following conditions:

General criteria:

  • Pregnant women (patient of childbearing potential must not be pregnant and mustagree to avoid pregnancy during the study by using an effective birth control methodfrom 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 thefour previous weeks and during the study period, being in an exclusion period for aprevious study

  • Patient deprived of freedom by administrative or legal decision or underguardianship

  • 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 vaginaldryness/atrophy

Criteria related to previous or ongoing treatments:

  • Patient with a condition or receiving a medication which, in the investigator'sjudgment, put the patient at undue risk

  • Patient suffering from systemic diseases and/or using concurrent therapy that mayinterfere with the evaluation of the study results

  • Patient undergoing a topical treatment on the test area or a systemic treatment suchas:

  • corticosteroids during the 2 previous weeks and during the study

  • retinoids and/or immunosuppressors during the 1.5 previous months and duringthe study

  • Patient having started or changed her oral contraceptive or any other hormonaltreatment during the three previous months

Study Design

Total Participants: 33
Treatment Group(s): 1
Primary Treatment: Mucogyne Ovule
Phase:
Study Start date:
April 11, 2024
Estimated Completion Date:
February 14, 2025

Connect with a study center

  • JEAN Christian's medical office

    Nogent-sur-Marne, 94130
    France

    Site Not Available

  • Dr Ramez GHADRI's medical office

    Orléans, 45100
    France

    Site Not Available

  • Dr Raïssa APERANO-MAS's medical office

    Rennes, 35000
    France

    Site Not Available

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