NCT05122065Unknown不适用
Defining the Vaginal Microbiome and the Vaginal pH of Menopausal Women With and Without Genitourinary Syndrome and With and Without Hormone Replacement Therapy
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 432
- 主要终点
- Vaginal microbiome sample collection
研究概览
简要总结
In this study the investigators will analyze the vaginal microbiome of menopausal women in order to shed light on its potential implication on menopausal symptoms and quality of life. Moreover, the investigators will assess the effect of hormone replacement treatment on symptoms and overall quality of life during menopause and whether women under hormone replacement treatment have distinct vaginal microbiome profiles.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who are females from birth
- •Women between 40-70 years old
- •Women that are US residents, understand, and speak English
- •Women of all race and ethnicities
- •Women that are postmenopausal (at least 12 consecutive months without a period)
- •Women with a naturally occuring menopause
- •Women willing to abstain from all sexual activity, feminine hygiene products (eg. douches, wipes, washes, sprays, powders, moisturizers/lubricants, deodorant suppositories, tablet suppositories, anti-itch creams, hot tubs) on the vaginal area, and any vaginal suppositories for 48 hours before sampling
- •Women who are healthy (without GSM)
- •Women who have GSM:
- •with formal diagnosis of GSM, or
- •who regularly experience a couple of the following symptoms: (i) vaginal dryness, vaginal burning, vaginal discharge & genital itching, vaginal irritation, (ii) light bleeding, discomfort or pain during or after intercourse, decreased lubrication during intercourse, decreased arousal, orgasm, libido, (iii) painful or difficult urination (dysuria), urinary frequency and urgency, recurrent UTIs (Urinary Tract Infections).
- •Women who either take or do not take HRT, including estrogen-only medicines, combination of estrogen/progestin medicines, combination of estrogen/other medicines.
排除标准
- •Women suffering from gynecological diseases including polycystic ovary syndrome, endometriosis, pelvic inflammatory disease, active HPV (human papillomavirus) or herpes simplex virus in the past few months, BV (Bacterial Vaginosis), yeast infections, or positive for any STD (Sexually Transmitted Disease; genital warts, chlamydia, gonorrhea, syphilis, trichomoniasis), HIV (Human Immunodeficiency Virus), cancer, type I diabetes, type II diabetes, chronic kidney disease.
- •Women having any genital surgery including removal of one or both ovaries, uterus or cervix.
- •Women whose menopause occurred by surgical operation (hysterectomy, oophorectomy), or drug/treatment (eg. chemotherapy, radiation therapy).
- •Women using douches daily or weekly.
- •Women who use on a regular basis one of the following: metformin, antihistamines, antidepressants, corticosteroids, boric acid, laxatives, antifungal/antimycotic medication.
- •Women using any oral or vaginal prebiotics, probiotics, or antibiotics in the past 6 months.
- •Women who take progestin-only medicines including progestin-only HRT.
结局指标
主要结局
Vaginal microbiome sample collection
时间窗: Baseline
Identify microbiome-based bacterial signatures to distinguish the different menopausal groups and the CST (Community State Type) group clustering according to the vaginal microbiome of menopausal women.
次要结局
- Vaginal pH -at home test kit(Baseline)
- Menopause Rating Scale (MRS) questionnaire(Baseline)
- Facial Skin Type Test(Baseline)
- Demographic questionnaire(Baseline)
- Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire(Baseline)
- Body Hydration Test(Baseline)
- Brief Resilience Scale (BRS) questionnaire(Baseline)
研究者
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