EUCTR2019-001435-31-ES进行中（未招募）1 期
Prospective and open clinical trial to evaluate the rapidity of action of a 0.005% estriol vaginal gel on the signs and symptoms of vaginal atrophy in postmenopausal women. BLISSET Study. - BLISSET Study
ITF Research Pharma S.L.U.0 个研究点目标入组 40 人开始时间: 2019年6月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Women between 45 and 75 years old.
- •Postmenopausal women (who have at least 12 months without menstruation) by natural process or by surgical intervention.
- •Women who present with vaginal symptoms resulting from vaginal atrophy, at least moderate-severe vaginal dryness, and in whom a local estrogen treatment is considered necessary to relieve their symptoms.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Women with a history of malignant or premalignant lesions in breast or endometrium, malignant colon or hepatic tumors, malignant melanoma, venous thromboembolic disorders (deep vein thrombosis, pulmonary embolism) or arterial thromboembolic disorders (cardiac ischemia, myocardial infarction, cerebrovascular accident) , peripheral arterial disease, thrombosis of the mesenteric artery, thrombosis of the renal artery or coagulopathies.
- •Women with vaginal bleeding of unknown etiology.
- •Women with uterovaginal prolapse grade II or higher, or signs and symptoms suggestive of infection of the genitals or urinary tract.
- •Women with an endometrial thickness equal to or greater than 4 mm measured by transvaginal ultrasound before the start of the study.
- •Women who have received any type of vulvovaginal treatment in the 15 days prior to the start of the study.
- •Women who have received phytoestrogens within 1 month before the start of the study (including vaginal administration).
- •Women who have received hormone therapy in the 3 months before the start of the study (including the administration of estrogen via the vagina).
- •Women who are being treated with estrogen or progestin, tibolone or selective modulators of the estrogen receptor, antiepileptic and urinary antiseptics.
- •Women who have received long-term antibiotic treatment (for two or more weeks) in the last 3 months before the start of the study.
- •Women in treatment with medications such as: antiepileptic drugs, antibiotics and anti-infectives.
- •Women who, for any reason, the researcher considers that they are not candidates to participate in this study.
研究者
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