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NCT07386249
Exploration of the Effect of a Wheat Polar Lipid Complex on Vaginal Dryness in Healthy Postmenopausal Women
Conditions: Vaginal Dryness, Menopause Symptoms
Sex: Female
Ages: 45 Years – 65 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 110
Sponsor: Seppic
Location: Center of Investigation in Clinical Nutrition (CICN) Louvain-la-Neuve Belgium
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
Eligibility Criteria
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 potentially interfere with the MRS assessment or participant safety
* Subject participating in another intervention trial
Source: ClinicalTrials.gov (NCT07386249). StuddyBuddy aggregates publicly available trial information.