Vaginal DrynessNCT07386249
Exploration of the Effect of a Wheat Polar Lipid Complex on Vaginal Dryness in Healthy Postmenopausal Women
A study testing Wheat Polar Lipid Complex in people with Vaginal Dryness and Menopause Symptoms, run by Seppic at 1 site in Belgium.
Trial 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 Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Dryness, Menopause Symptoms
- What is being tested?
- Wheat Polar Lipid Complex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Feb 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Center of Investigation in Clinical Nutrition (CICN)
Louvain-la-Neuve, Belgium, 1348
Valérie Dormal, PhD, +32(0)10 47 93 05, valerie.dormal@uclouvain.be
Louise Deldicque, Pr, +32(0)10 47 44 43, louise.deldicque@uclouvain.be
About this study
This study aims to explore the positive effect of a dietary supplement composed of wheat polar lipids on vaginal dryness in healthy postmenopausal women
Read the 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.
- Conditions
- Vaginal Dryness, Menopause Symptoms
- Being tested
- Wheat Polar Lipid Complex, Placebo
- Keywords
- Menopause, Wheat polar lipids, Vaginal dryness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheat Polar Lipid ComplexDietary supplement
The study foresees the intake of 1 capsule per day during 12 weeks
PlaceboDietary supplement
The study foresees the intake of 1 capsule per day during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| WPLC | Experimental | Dietary supplement - Wheat Polar Lipid Complex Receives: Dietary Supplement: Wheat Polar Lipid Complex |
| Placebo | Placebo comparator | Dietary supplement - Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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")
Measured: 2, 4, 6, 8, 10 and 12 weeks
Secondary outcomes (5)
Change in vaginal pH level
Comparison between groups of the vaginal pH level assessed using a testing strip
Measured: 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
Measured: 6 and 12 weeks
Change in menopause-specific quality of life
Comparison between groups of menopause-specific quality of life assessed by the Menopause-Specific Quality of Life (MENQOL) questionnaire
Measured: 6 and 12 weeks
Change in functional and emotional impact of vulvovaginal symptoms
Comparison between groups of functional and emotional impact of vulvovaginal symptoms assessed by the Day-to-day Impact of Vaginal Aging (DIVA) questionnaire
Measured: 6 and 12 weeks
Evolution of self-perceived improvement of vaginal dryness and menopausal symptoms
Comparison between groups of the adjusted for baseline of self-perceived improvement of vaginal dryness and menopausal symptoms assessed by a visual analogue scale, ranging from 0 = not at all to 4 = very much
Measured: 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start2 Feb 2026
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal DrynessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparative, randomized, placebo-controlled, double-blind, monocentric interventional study in parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seppic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Louise Deldicque, Pr, Study director, Université Catholique de LouvainSylvie Copine, Dr, Principal investigator, Université Catholique de LouvainLaurent Simar, Dr, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386249
- Sponsor's protocol ID
- MenoWPLC
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Effect of a Wheat Polar Lipid Complex on Vaginal Dryness in Healthy Postmenopausal Women
- ClinicalTrials.gov ID
- NCT07386249
- Acronym / sponsor ID
- MenoWPLC
- Conditions
- Vaginal Dryness, Menopause Symptoms
- Keywords
- Menopause, Wheat polar lipids, Vaginal dryness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- SeppicIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Comparative, randomized, placebo-controlled, double-blind, monocentric interventional study in parallel groups
| Arm | Type | Receives |
|---|---|---|
| WPLC | Experimental | Dietary Supplement: Wheat Polar Lipid ComplexDietary supplement - Wheat Polar Lipid Complex |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDietary supplement - Placebo |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wheat Polar Lipid ComplexThe study foresees the intake of 1 capsule per day during 12 weeks | Dietary supplement | WPLC |
| PlaceboThe study foresees the intake of 1 capsule per day during 12 weeks | Dietary supplement | Placebo |
Primary outcome
Change in vaginal dryness intensity
Time frame: 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")
5 secondary outcomes
Change in vaginal pH level
Time frame: 6 and 12 weeks
Change in menopausal symptoms severity
Time frame: 6 and 12 weeks
Change in menopause-specific quality of life
Time frame: 6 and 12 weeks
Change in functional and emotional impact of vulvovaginal symptoms
Time frame: 6 and 12 weeks
Evolution of self-perceived improvement of vaginal dryness and menopausal symptoms
Time frame: 6 and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Louise Deldicque, Pr study director
Université Catholique de Louvain
Sylvie Copine, Dr principal investigator
Université Catholique de Louvain
Laurent Simar, Dr principal investigator
Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wheat Polar Lipid Complex in people with Vaginal Dryness and Menopause Symptoms, run by Seppic at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valérie Dormal, PhD (+32(0)10 47 93 05, valerie.dormal@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in vaginal dryness intensity (time frame: 2, 4, 6, 8, 10 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.