A prospective, non-interventional, Active post marketing surveillance study of Lenzetto (Estradiol 1.53 mg/actuation transdermal spray) in postmenopausal women.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 18
- 主要终点
- To monitor the Local Skin Tolerability; occurrence of all commonly reported AEs including any clinically relevant differences observed in lab parameters, vital signs or physical examination findings: Local Skin Tolerability, Adverse Event Reporting, Lipid Profile, Vital Signs, Physical Examination.
研究概览
简要总结
Menopause hormone replacement therapy (HRT) is the most efficient treatment for symptoms of acute climacteric syndrome and for efficient prevention of long-term estrogen deficiency. Vaginal administration of low doses of estrogen is a therapy of choice for treatment and prevention of urogenital atrophy and its consequences.
Lenzetto (Estradiol 1.53 mg/actuation transdermal spray), is approved in Europe and the same product was approved by the DCGI on 17 August 2021, for Themis Medicare Ltd to import and market the same product in India. Themis Medicare has started marketing this product in India since January 2023.
This active post marketing surveillance study has been designed to assess the safety and efficacy of Estradiol 1.53 mg/actuation transdermal spray when administered transdermally to the inner forearm once daily for 12 weeks in post-menopausal women.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 35.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
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
- •Refusal to sign the informed consent
- •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;.
- •Hypersensitivity to the active substance or to any of the excipients.
结局指标
主要结局
To monitor the Local Skin Tolerability; occurrence of all commonly reported AEs including any clinically relevant differences observed in lab parameters, vital signs or physical examination findings: Local Skin Tolerability, Adverse Event Reporting, Lipid Profile, Vital Signs, Physical Examination.
时间窗: Baseline, Week 4, Week 8, Week 12
次要结局
- Assessment of climacteric symptoms/severity by five point Menopause Rating Scale (MRS).(Mean change in frequency of mild, moderate and severe vasomotor symptoms.)
研究者
Dr Balaji More
Themis Medicare Limited