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

NCT07386249 | Recruiting

• 1 other identifier: MenoWPLC
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Vaginal Dryness; Menopause Symptoms

Keywords

Menopause; Wheat polar lipids; Vaginal dryness

Outcome Measures

Primary Outcomes (1)

• Change in vaginal dryness intensity

  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")

  2, 4, 6, 8, 10 and 12 weeks

Secondary Outcomes (5)

• Change in vaginal pH level

  6 and 12 weeks

• Change in menopausal symptoms severity

  6 and 12 weeks

• Change in menopause-specific quality of life

  6 and 12 weeks

• Change in functional and emotional impact of vulvovaginal symptoms

  6 and 12 weeks

• Evolution of self-perceived improvement of vaginal dryness and menopausal symptoms

  6 and 12 weeks

Study Arms (2)

WPLC

EXPERIMENTAL

Dietary supplement - Wheat Polar Lipid Complex

Dietary Supplement: Wheat Polar Lipid Complex

Placebo

PLACEBO COMPARATOR

Dietary supplement - Placebo

Dietary Supplement: Placebo

Interventions

Wheat Polar Lipid Complex DIETARY_SUPPLEMENT

The study foresees the intake of 1 capsule per day during 12 weeks

WPLC

Placebo DIETARY_SUPPLEMENT

The study foresees the intake of 1 capsule per day during 12 weeks

Placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Gender Eligibility Details: Biological females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seppic: lead

Study Sites (1)

Center of Investigation in Clinical Nutrition (CICN)

Louvain-la-Neuve, Belgium, 1348, Belgium

RECRUITING

Study Officials

• Louise Deldicque, Pr

  Université Catholique de Louvain

  STUDY DIRECTOR

• Sylvie Copine, Dr

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

• Laurent Simar, Dr

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valérie Dormal, PhD

CONTACT

+32(0)10 47 93 05; valerie.dormal@uclouvain.be

Louise Deldicque, Pr

CONTACT

+32(0)10 47 44 43; louise.deldicque@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Comparative, randomized, placebo-controlled, double-blind, monocentric interventional study in parallel groups

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 4, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)