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.
Sponsor study identifier
Secondary identifiers
OTHER · Company Internal
observational
749
1 country
1
Study Start
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2009
Actual (reported)Study Completion
May 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2009
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
May 2009
Actual (reported)May 2009
Actual (reported)June 3, 2009
Actual (reported)June 4, 2009
Actual (reported)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
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
Patients in daily life treatment receiving Wellnara according to local drug information.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The target population of this study are women who have received a prescription of Wellnara on the basis of the decision of the treating gynecologist. The study is expected to collect data of up to 2,400 women in about 700 gynecological practices in Germany.
Many Locations, Germany
Bayer Study Director
Bayer
749 participants (actual enrollment reported by the registry).
First Submitted
June 3, 2009
First Posted
June 4, 2009
Study Start
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
Study Evaluating Potential Drug Interaction Of Bazedoxifene & Premarin In Healthy Postmenopausal Women
Contact the study team to confirm eligibility.
Primary Completion
May 2009
Actual (reported)Study Completion
May 2009
Actual (reported)Last Updated
April 22, 2015
Record last verified: 2015-04
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Source: ClinicalTrials.gov.
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