Effects of Wellnara on Climacteric Symptoms

Completed

• Conditions: Postmenopause
• Interventions: Drug: E2/LNG oral (Wellnara, BAY86-5029)

• Registration Number: NCT00913926
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Study First Submitted: 2009-06-03
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 749

Inclusion Criteria

• Women who have received a prescription of Wellnara on the basis of the decision of the treating gynecologist

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Exclusion Criteria

• Limited to the criteria listed in the expert information as contraindications

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	E2/LNG oral (Wellnara, BAY86-5029)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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