NCT06282614TerminatedNot Applicable
MOVHYDA (MUCO245) - Performance and Safety of MUCOGYNE® Ovule as a Moisturizer
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Biocodex
- Enrollment
- 33
- Locations
- 6
- Primary Endpoint
- Assessment of the efficacy of MUCOGYNE® Ovule intra vaginal applications on subjects' vaginal dryness irrespective of the cause over a 35-day period of use
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Assessment of the efficacy of MUCOGYNE® Ovule intra vaginal applications on subjects' vaginal dryness irrespective of the cause over a 35-day period of use
Time Frame: Day 0 to Day 35 ± 3
Primary efficacy criterion: Clinical scoring, by the investigator, of the Vaginal Health Index Score (VHIS), including evaluation of elasticity, fluid volume, pH, epithelial integrity, and moisture. The minimum score is 5 and the maximum score is 25. If VHIS \<15, the vagina is considered atrophic.
Secondary Outcomes
- Assessment of the patient's sexual function(Day 0 to Day 35 ± 3)
- Assessment of the usability of MUCOGYNE® Ovule(Day 0 to Day 35 ± 3)
- Assessment of the safety of MUCOGYNE® Ovule(Day 0 to Day 35 ± 3)
- Assessment of the device deficiencies of MUCOGYNE® Ovule(Day 0 to Day 35 ± 3)
- Assessment by investigator of changes in patient's clinical status(Day 0 to Day 35 ± 3)
- Assessment of the local performance of MUCOGYNE® Ovule in reducing vulva irritation(Day 0 to Day 35 ± 3)
- Assessment of the local performance of MUCOGYNE® Ovule in reducing vulvo-vaginal discomfort(Day 0 to Day 35 ± 3)
- Assessment of the patient's satisfaction(Day 0 to Day 35 ± 3)
- Assessment of changes in patient's clinical status(Day 0 to Day 35 ± 3)
- Assessment of the local performance of MUCOGYNE® Ovule in reducing pain and/or dyspareunia related to vaginal dryness(Day 0 to Day 35 ± 3)
- Assessment of the local performance of MUCOGYNE® Ovule in reducing itching(Day 0 to Day 35 ± 3)
Investigators
Study Sites (6)
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