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Performance and Safety of MUCOGYNE® Ovule as a Moisturizer | Clinical Trials | Clareo Health

TERMINATEDNA

Performance and Safety of MUCOGYNE® Ovule as a Moisturizer

MOVHYDA (MUCO245) - Performance and Safety of MUCOGYNE® Ovule as a Moisturizer

NCT06282614•Biocodex

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

Age

18 - No limit years

Sex

FEMALE

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
+8 more criteria

Locations (3)

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

Key Dates

Start Date

April 11, 2024

Primary Completion Date

February 14, 2025

Completion Date

February 14, 2025

Last Updated

April 13, 2025

Enrollment

ACTUAL participants

Conditions

Vaginal Dryness

Interventions

Mucogyne Ovule

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Performance and Safety of MUCOGYNE® Ovule as a Moisturizer

Inclusion Criteria

Exclusion Criteria

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