Effects of Wellnara on Climacteric Symptoms

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Postmenopause

Intervention / Treatment
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* Drug: E2/LNG oral (Wellnara, BAY86-5029)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who have received a prescription of Wellnara on the basis of the decision of the treating gynecologist Exclusion Criteria: Limited to the criteria listed in the expert information as contraindications
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: E2/LNG oral (Wellnara, BAY86-5029)<br>* Patients in daily life treatment receiving Wellnara according to local drug information.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  | At Baseline, after 3 months, after 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on climacteric-related skin, hair, and sexual problems |  | At Baseline, after 3 months, after 6 months | 
| Subjective assessment of efficacy |  | After end of study | 
| Body weight |  | At Baseline, after 3 months, after 6 months | 
| Blood Pressure |  | At baseline, end of Study | 
| Waist-hip-ratio (as far as routinely used in the practice) |  | At baseline, after 6 months | 
| Occurrence of vaginal bleeding |  | After 3 months, after 6 months | 
| Subjective assessment of tolerability |  | End of study | 
| Adverse drug reactions |  | During the whole study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Climacteric symptoms