Exploration of the Effect of a Wheat Polar Lipid Complex... | NCT07386249

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

NCT07386249

Sponsor

Seppic

Status

Recruiting

Last Update Posted

Apr 23, 2026Actual

Enrollment

110Estimated

Phase

Not Applicable

Conditions

Vaginal Dryness
Menopause Symptoms

Interventions

Wheat Polar Lipid Complex
Placebo

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2, 2026Actual

Primary Completion Date

Oct 2026Estimated

Completion Date

Nov 2026Estimated

First Submitted Date

Jan 28, 2026

First Submission Date that Met QC Criteria

Jan 28, 2026

First Posted Date

Feb 4, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2026

Last Update Posted Date

Apr 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

This study is designed as a randomized double-blind placebo-controlled interventional study. One hundred and ten postmenopausal women, aged between 45 and 65 and experiencing vaginal dryness, will be randomly allocated to the control (placebo supplement) or test (active supplement) group. Participants will be supplemented during 12 weeks with those products. Vaginal dryness intensity and menopause symptoms severity will be measured with tests and questionnaires before (baseline), at the middle (6 weeks), and at the end (12 weeks) of the intervention.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
WPLC	Experimental	Dietary supplement - Wheat Polar Lipid Complex	Dietary Supplement: Wheat Polar Lipid Complex
Placebo	Placebo Comparator	Dietary supplement - Placebo	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Wheat Polar Lipid Complex	Dietary Supplement	The study foresees the intake of 1 capsule per day during 12 weeks	WPLC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Change in vaginal pH level	Comparison between groups of the vaginal pH level assessed using a testing strip	6 and 12 weeks
Change in menopausal symptoms severity	Comparison between groups of the menopausal symptoms severity assessed by the Menopause Rating Scale (MRS) questionnaire

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Biological females

Minimum Age

45 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Name	Affiliation	Role
Louise Deldicque, Pr	Université Catholique de Louvain	Study Director
Sylvie Copine, Dr	Université Catholique de Louvain	Principal Investigator
Laurent Simar, Dr

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center of Investigation in Clinical Nutrition (CICN)	Recruiting	Louvain-la-Neuve	Belgium	1348	Belgium