Performance and Safety of MUCOGYNE® Ovule as a Moisturizer (NCT06282614) | Clinical Trial Compass
TerminatedNot Applicable
Performance and Safety of MUCOGYNE® Ovule as a Moisturizer
Stopped: Early efficacy at interim analysis.
France33 participantsStarted 2024-04-11
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 interventiona…
What they're measuring
1
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