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
Qualifiers
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
Treatments tested in this trial
- Wheat Polar Lipid Complex
- Placebo
Treatment groups
110 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov