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New treatment option for Vaginal Dryness
Official title Exploration of the Effect of a Wheat Polar Lipid Complex on Vaginal Dryness in Healthy Postmenopausal Women
ClinicalTrials.gov ID: NCT07386249
What this study is testing
- What it's testing
- This study aims to explore the positive effect of a dietary supplement composed of wheat polar lipids on vaginal dryness in healthy postmenopausal women
- Time commitment: about 12 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 65, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Louvain-la-Neuve, Belgium, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 45 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Louvain-la-Neuve, Belgium, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.