Menopause Symptoms, Vaginal Dryness
Conditions
Keywords
Menopause, Wheat polar lipids, Vaginal dryness
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.
Interventions
DIETARY_SUPPLEMENTWheat Polar Lipid Complex
The study foresees the intake of 1 capsule per day during 12 weeks
DIETARY_SUPPLEMENTPlacebo
The study foresees the intake of 1 capsule per day during 12 weeks
Sponsors
Seppic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Comparative, randomized, placebo-controlled, double-blind, monocentric interventional study in parallel groups
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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") |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in vaginal pH level | 6 and 12 weeks | Comparison between groups of the vaginal pH level assessed using a testing strip |
| Change in menopausal symptoms severity | 6 and 12 weeks | Comparison between groups of the menopausal symptoms severity assessed by the Menopause Rating Scale (MRS) questionnaire |
| Change in menopause-specific quality of life | 6 and 12 weeks | Comparison between groups of menopause-specific quality of life assessed by the Menopause-Specific Quality of Life (MENQOL) questionnaire |
| Change in functional and emotional impact of vulvovaginal symptoms | 6 and 12 weeks | Comparison between groups of functional and emotional impact of vulvovaginal symptoms assessed by the Day-to-day Impact of Vaginal Aging (DIVA) questionnaire |
| Evolution of self-perceived improvement of vaginal dryness and menopausal symptoms | 6 and 12 weeks | 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 |
Countries
Belgium
Contacts
CONTACTValérie Dormal, PhD
CONTACTLouise Deldicque, Pr
STUDY_DIRECTORLouise Deldicque, Pr
Université Catholique de Louvain
PRINCIPAL_INVESTIGATORSylvie Copine, Dr
Université Catholique de Louvain
PRINCIPAL_INVESTIGATORLaurent Simar, Dr
Université Catholique de Louvain
Outcome results
None listed