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
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