Exploration of the Effect of a Wheat Polar Lipid Complex on Vaginal Dryness in Healthy Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change in vaginal dryness intensity
研究概览
简要总结
This study aims to explore the positive effect of a dietary supplement composed of wheat polar lipids on vaginal dryness in healthy postmenopausal women
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
WPLC
Dietary supplement - Wheat Polar Lipid Complex
干预措施: Wheat Polar Lipid Complex (Dietary Supplement)
Placebo
Dietary supplement - Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in vaginal dryness intensity
时间窗: 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")
次要结局
- Change in vaginal pH level(6 and 12 weeks)
- Change in menopausal symptoms severity(6 and 12 weeks)
- Change in menopause-specific quality of life(6 and 12 weeks)
- Change in functional and emotional impact of vulvovaginal symptoms(6 and 12 weeks)
- Evolution of self-perceived improvement of vaginal dryness and menopausal symptoms(6 and 12 weeks)