Trial Condition(s):

Postmenopause

Effects of Wellnara on climacteric symptoms

Bayer Identifier:

14575

ClinicalTrials.gov Identifier:

NCT00913926

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
749
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Wellnara (E2/LNG oral, BAY86-5029)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Germany

Status
Completed
 

Trial Design