Wheat polar lipid supplement for vaginal dryness in postmenopausal women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: valerie.dormal@uclouvain.be
• Phone: +32(0)10 47 93 05

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.