Combination therapy with Probiotics and Estrogen vaginal cream versus Estrogen vaginal cream for treatment of genitourinary syndrome in Postmenopausal women – A Randomized open label clinical trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- CHECK FOR THE NUGENT SCORE
研究概览
简要总结
Combination therapy with Probiotics and Estrogen vaginal cream versus Estrogen vaginal cream for treatment of genitourinary syndrome in Postmenopausal women
Patient will be assessed on clinical symptoms vaginal PH Nugent score vaginal health index
patients will be assessed initially and after 8 and 12weeks regarding the progress of usage of probiotics and vaginal estrogen cream
Outcome Changes in Nugents score, Vaginal pH, VHI and severity of patient reported symptoms
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 45.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Postmenopausal women with genitourinary syndrome Diagnosis of GSM in our study will be based on the presence of at least 1 symptoms with pH more than or equal to 4.5 and the symptoms not attributed to any other pathology Symptoms Genital -Dryness, Burning, Irritation Sexual -Lack of lubrication, discomfort or pain Urinary- Urgency, Dysuria, Recurrent UTI.
排除标准
- •Previous local or systemic menopausal hormone therapy Hormone -dependent tumors Vaginal bleeding of unknown cause Taken antibiotics 2 weeks prior to start treatment Any other lesions in cervix, vagina and vulva Acute infections of the genital tract, use of any vaginal therapy, severe systemic diseases, all contraindications for administration of estrogen, and participation in another study.
- •Patients already taking probiotics.
结局指标
主要结局
CHECK FOR THE NUGENT SCORE
时间窗: CHECK FOR THE NUGENT SCORE | VAGINAL PH | CLINICAL IMPROVEMENT | VAGINAL HEALTH INDEX | at 8weeks and 12weeks
VAGINAL PH
时间窗: CHECK FOR THE NUGENT SCORE | VAGINAL PH | CLINICAL IMPROVEMENT | VAGINAL HEALTH INDEX | at 8weeks and 12weeks
CLINICAL IMPROVEMENT
时间窗: CHECK FOR THE NUGENT SCORE | VAGINAL PH | CLINICAL IMPROVEMENT | VAGINAL HEALTH INDEX | at 8weeks and 12weeks
VAGINAL HEALTH INDEX
时间窗: CHECK FOR THE NUGENT SCORE | VAGINAL PH | CLINICAL IMPROVEMENT | VAGINAL HEALTH INDEX | at 8weeks and 12weeks
次要结局
未报告次要终点
研究者
Dr Bommareddy Pooja
SRM Medical College Hospital and research center