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.
Study Type
OBSERVATIONAL
Enrollment
749
Patients in daily life treatment receiving Wellnara according to local drug information.
Unnamed facility
Many Locations, Germany
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).
Time frame: At Baseline, after 3 months, after 6 months
Effects on climacteric-related skin, hair, and sexual problems
Time frame: At Baseline, after 3 months, after 6 months
Subjective assessment of efficacy
Time frame: After end of study
Body weight
Time frame: At Baseline, after 3 months, after 6 months
Blood Pressure
Time frame: At baseline, end of Study
Waist-hip-ratio (as far as routinely used in the practice)
Time frame: At baseline, after 6 months
Occurrence of vaginal bleeding
Time frame: After 3 months, after 6 months
Subjective assessment of tolerability
Time frame: End of study
Adverse drug reactions
Time frame: During the whole study
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