NCT03385551已完成不适用
Observational Study to Evaluate the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Vulvovaginal Symptoms
研究概览
简要总结
This is a study to evaluate the acceptability, efficacy and preferences of 10 of estradiol vaginal tablets vs promestriene vaginal cream
详细描述
This is an observational, prospective, open-label, parallel-group study to evaluate the acceptability, efficacy, and preferences of postmenopausal women older than 45 between 10 micrograms of estradiol vaginal tablets vs promestriene vaginal cream
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women aged 45 years or older. Women will be considered postmenopausal with more than 12 months since last menstrual period
- •Women who have been prescribed vaginal estradiol tablets or vaginal promestriene cream· Women who have read and signed the Informed Consent Form
- •Women with an intact uterus
- •One or more vaginal symptoms (dryness, soreness, irritation, dyspareunia) rated as moderate to severe. Symptoms are moderate if the patient needs a treatment and feels discomfort. Symptoms are severe if the patient needs a treatment, and feels such a degree of discomfort that this could severely impact the subject's daily activities
- •In case of doubt, blood estradiol concentration will be determined, and the subject will only be enrolled if the levels are equal to 30pg./ml. or less.
排除标准
- •Women who had a known or suspected history of breast carcinoma
- •Estrogen dependent neoplasia. Women with a known, past or suscpected Estrogen-dependent malignant tumours such as endormetrial or ovarian cancer
- •Positive or suspicious mammogram results
- •Any systemic malignant disease
- •Hormone therapy treatment (sex hormones or vaginal treatments or steroids) in the last three months Women who had abnormal vaginal bleeding or uterine bleeding of unknown cause
- •Vaginal infection requiring treatment
- •Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism) Untreated endometrial hyperplasia Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency) Active or previous arterial thromboembolic disease (e.g. angina, myocardial infarction) Acute liver disease, or history of liver disease as long as liver function tests have failed to return to normal Known Hypersensitivity to the active substances or to any of the excipients Porphyria
- •Any serious disease or chronic condition that could interfere with study compliance
- •History of thrombolytic disorders
- •Use of vaginal contraceptives (DIU, vaginal ring...)
- •Participation in another clinical trial in the last three months.
研究组 & 干预措施
ARM 1
Patients who have been prescribed by the physician within the standard clinical practice 10 micrograms of estradiol vaginal tablets. One tablet intravaginally once daily for two weeks. Thereafter one tablet twice per week with at least a 3-days interval between treatments
干预措施: Estradiol (Drug)
结局指标
主要结局
Vulvovaginal Symptoms
时间窗: Change from Baseline, at week 4 and at week 12
Dispareunya, dryness, itching nd burning
次要结局
未报告次要终点
研究者
研究点 (2)
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