Exploration of the Effect of a Wheat Polar Lipid Complex on Vaginal Dryness in Healthy Postmenopausal Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorSeppic
About this trial
This study aims to explore the positive effect of a dietary supplement composed of wheat polar lipids on vaginal dryness in healthy postmenopausal women
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Wheat Polar Lipid Complex
Dietary supplementThe study foresees the intake of 1 capsule per day during 12 weeks
Placebo
Dietary supplementThe study foresees the intake of 1 capsule per day during 12 weeks
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: WPLCExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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")
Time frame
2, 4, 6, 8, 10 and 12 weeksSecondary outcomes
1
Change in vaginal pH level
Comparison between groups of the vaginal pH level assessed using a testing strip
Time frame
6 and 12 weeks2
Change in menopausal symptoms severity
Comparison between groups of the menopausal symptoms severity assessed by the Menopause Rating Scale (MRS) questionnaire
Time frame
6 and 12 weeks3
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
Time frame
6 and 12 weeks4
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
Time frame
6 and 12 weeks Source ClinicalTrials.gov