Wheat polar lipid supplement for vaginal dryness in postmenopausal women

Exploration of the Effect of a Wheat Polar Lipid Complex on Vaginal Dryness in Healthy Postmenopausal Women

This trial will test whether a daily wheat polar lipid dietary supplement can reduce vaginal dryness in healthy postmenopausal women.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 45 Years to 65 Years
• Sex: Female
• Sponsor: Seppic (industry)
• Locations: 1 site (Louvain-la-Neuve, Belgium)
• Trial ID: NCT07386249 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled study will enroll 110 postmenopausal women aged 45–65 with bothersome vaginal dryness. Participants will be randomly assigned to receive either the wheat polar lipid supplement or a matched placebo daily for 12 weeks. Vaginal dryness intensity and overall menopause symptom severity will be measured at baseline, 6 weeks, and 12 weeks using a 0–10 visual analogue scale and the Menopause Rating Scale. The trial is conducted at the Center of Investigation in Clinical Nutrition in Louvain‑la‑Neuve, Belgium.

Who should consider this trial

Good fit: Ideal candidates are healthy postmenopausal women aged 45–65 (no periods for ≥12 months) who report vaginal dryness (VAS ≥4 and MRS ≥16), speak French, and can attend study visits in Belgium.

Not a fit: Women using recent systemic or vaginal hormonal therapies, recent menopause-targeted supplements, or those without significant vaginal dryness or who cannot attend in-person visits are unlikely to benefit from this study.

Why it matters

Potential benefit: If effective, the supplement could offer a non-hormonal, oral option to reduce vaginal dryness and improve menopausal symptoms.

How similar studies have performed: Use of wheat polar lipids for vaginal dryness is relatively novel with limited prior clinical data, though some non-hormonal supplement approaches for menopausal symptoms have shown mixed results.

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

Where this trial is running

Louvain-la-Neuve, Belgium

• Center of Investigation in Clinical Nutrition (CICN) — Louvain-la-Neuve, Belgium, Belgium (RECRUITING)

Study contacts

• Principal investigator: Sylvie Copine, Dr — Université Catholique de Louvain
• Study coordinator: Valérie Dormal, PhD

Conditions: Vaginal Dryness, Menopause Symptoms, Menopause, Wheat polar lipids, Vaginal dryness