CTRI/2024/04/066430招募中4 期
A prospective, non-interventional, Active post marketing surveillance study of Lenzetto (Estradiol 1.53 mg/actuation transdermal spray) in postmenopausal women. - NI
试验速览
- 阶段
- 4 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •Naturally or surgically postmenopausal women (35 years or older) with a history of moderate to severe vasomotor symptoms: adequate washout period from estrogen-containing products prior to baseline assessments if previously treated.
排除标准
- •1. Refusal to sign the informed consent
- •2. Contraindications for the use of Lenzetto according to the prescribing information (below):
- •- Known, past or suspected breast cancer;
- •- Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer);
- •- Undiagnosed genital bleeding;
- •- Untreated endometrial hyperplasia;
- •- Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism);
- •- Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency)
- •- Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction);
- •- Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal;
- •- Porphyria;
- •- Hypersensitivity to the active substance or to any of the excipients.
研究者
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