Evaluation of the Efficacy and Safety of Mucogye® Gel as a Moisturizer (NCT05913479) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Efficacy and Safety of Mucogye® Gel as a Moisturizer
France34 participantsStarted 2023-10-10
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
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).
* 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:
* Know…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of the efficacy of MUCOGYNE® Gel intra vaginal applications on subjects' vaginal dryness irrespective of the cause over a 35-day period of use.