Exploration of the Effect of a Wheat Polar Lipid Complex on Vaginal Dryness in Healthy Postmenopa… (NCT07386249) | Clinical Trial Compass
RecruitingNot Applicable
Exploration of the Effect of a Wheat Polar Lipid Complex on Vaginal Dryness in Healthy Postmenopausal Women
Belgium110 participantsStarted 2026-02-02
Plain-language summary
This study aims to explore the positive effect of a dietary supplement composed of wheat polar lipids on vaginal dryness in healthy postmenopausal women
Who can participate
Age range
45 Years – 65 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:
* Healthy woman, aged of 45 to 65 years (inclusive)
* In postmenopause, defined according to the STRAW criteria as the absence of menstrual periods for at least 12 consecutive months
* Reporting a vaginal dryness intensity score ≥ 4 on a 0-10 Visual Analogue Scale (VAS), and a score ≥ 16 on the Menopause Rating Scale (MRS)
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Stated willingness to maintain their usual life habits (diet, physical activity, alcohol consumption…)
* Speaking French.
Exclusion Criteria:
* Use of systemic hormonal therapy within the past 3 months
* Use of dietary supplements, herbal products, or over-the-counter remedies intended to alleviate menopausal symptoms within 4 weeks prior to the screening visit (wash-out period ≥ 1 month required)
* Use of vaginal hormonal formulations within 4 weeks prior to screening
* History of hormone-dependent cancers
* History of hysterectomy or bilateral oophorectomy
* Current alcohol dependence or excessive alcohol consumption exceeding an average of 14 standard drinks per week
* Current use of illicit drugs or recent history of drug dependence
* Current or previously diagnosed eating disorders considered likely to impact participant safety or study outcomes
* Presence of severe or uncontrolled chronic medical conditions, or any acute medical condition judged by the investigator to pot…
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.