Multicenter Non-interventional Study on Efficacy, Tolerability, and Acceptance of Wellnara Containing 1.03 mg Estradiol Hemihydrate (Equivalent to 1 mg Estradiol) and 0.04 mg Levonorgestrel for Treatment of Hormone Deficiency Symptoms in Postmenopausal Women During 6 Cycles of 28 Days.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 749
- 主要终点
- Primary endpoint in the observation of efficacy concerning climacteric complaints is the change in Menopause Rating Scale (MRS II) in relation to the status immediately before starting treatment (Baseline).
研究概览
简要总结
Aim of this NIS is to obtain further information on efficacy, tolerability, and acceptance of Wellnara in a large user population under the conditions of routine medical practice. Furthermore, any adverse drug reactions will be recorded in a large user population under the conditions of medical routine. To investigate the efficacy of Wellnara, patients will fill in a questionnaire, the so-called Menopause Rating Scale (MRS II). Further, the effects of treatment on skin and hair will be evaluated by the investigator. Patients will assess treatment effects on their sexual life. Safety parameters include monitoring of vaginal bleeding, measurement of blood pressure and body weight, and - as far as routinely used in the practice - calculation of waist-hip-ratio. Any relevant additional information related to adverse drug reactions will also be documented.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who have received a prescription of Wellnara on the basis of the decision of the treating gynecologist
排除标准
- •Limited to the criteria listed in the expert information as contraindications
研究组 & 干预措施
Group 1
干预措施: E2/LNG oral (Wellnara, BAY86-5029) (Drug)
结局指标
主要结局
Primary endpoint in the observation of efficacy concerning climacteric complaints is the change in Menopause Rating Scale (MRS II) in relation to the status immediately before starting treatment (Baseline).
时间窗: At Baseline, after 3 months, after 6 months
次要结局
- Subjective assessment of efficacy(After end of study)
- Blood Pressure(At baseline, end of Study)
- Occurrence of vaginal bleeding(After 3 months, after 6 months)
- Subjective assessment of tolerability(End of study)
- Effects on climacteric-related skin, hair, and sexual problems(At Baseline, after 3 months, after 6 months)
- Waist-hip-ratio (as far as routinely used in the practice)(At baseline, after 6 months)
- Adverse drug reactions(During the whole study)
- Body weight(At Baseline, after 3 months, after 6 months)