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

What this trial studies

This study aims to explore the positive effect of a dietary supplement composed of wheat polar lipids on vaginal dryness in healthy postmenopausal women

Conditions in scope

• Vaginal Dryness
• Menopause Symptoms

Interventions

• Wheat Polar Lipid Complex (Dietary Supplement) — The study foresees the intake of 1 capsule per day during 12 weeks
• Placebo (Dietary Supplement) — The study foresees the intake of 1 capsule per day during 12 weeks

Who can join

Women only · Ages 45 Years to 65 Years · Accepts healthy volunteers.

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2026-02-02
• Primary completion: 2026-10
• Last update posted: 2026-04-23
• First posted: 2026-02-04

Sponsor & contact

Lead sponsor: Seppic (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Change in vaginal dryness intensity (2, 4, 6, 8, 10 and 12 weeks)
  Comparison between groups of the vaginal dryness intensity assessed by a Visual Analogue Scale ranging from 0 ("no dryness at all") to 10 ("extreme vaginal dryness")

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.