NCT04232813已完成3 期
Evaluation of 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
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Vulvovaginal Symptoms
研究概览
简要总结
Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream in postmenopausal women aged 45 years or older, with one or more moderate to severe symptoms of vulvovaginal atrophy (dryness, dyspareunia, soreness or irritation).
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
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
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 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.
- •Blood estradiol concentration of 30 pg/ml or less .
排除标准
- •Women who have not signed the Informed consent Form
- •Women who had a known or suspected history of breast carcinoma
- •Estrogen dependent neoplasia. Women with a known, past or suspected Estrogen-dependent malignant tumours such as endometrial 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
Estradiol 10 micrograms vaginal tablets
Active Comparator
One tablet intravaginally once daily for two weeks. Thereafter one tablet twice per week with at least a 3-days interval between treatments to maintain therapeutic response.
干预措施: Estradiol 10 MCG Vaginal Tablet [VAGIFEM] (Drug)
Promestriene 10mg./g vaginal cream
Active Comparator
One application once daily intravaginally for two weeks. Thereafter one application twice per week with at least a 3-days interval between treatments to maintain therapeutic response.
干预措施: Promestriene Vaginal (Drug)
结局指标
主要结局
Vulvovaginal Symptoms
时间窗: Change from Baseline, at week 4 and at week 12
Percentage of patients with vulvovaginal atrophy that accept 17B-Estradiol vaginal tablets vs promestriene vaginal cream after 12 weeks
次要结局
- Evaluation of relief of atrophic vaginitis symptoms using intensity ratings of none, mild, moderate or severe of dryness and dyspareunia.(Change from Baseline, at week 4 and at week 12)
- Evaluation of vaginal maturation index by Pap smear.(Change from Baseline, at week 4 and at week 12)
- Evaluation of changes in ph.(Change from Baseline, at week 4 and at week 12)
- Occurrence of adverse events(Change from Baseline, at week 4 and at week 12)
- Evaluation of endometrium thickness using vaginal ultrasound(Change from Baseline, at week 4 and at week 12)
- Evaluation of changes in soreness and irritation.(Change from Baseline, at week 4 and at week 12)
研究者
研究点 (1)
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