Effects of Wellnara on Climacteric Symptoms
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.
2 other identifiers
observational
749
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 3, 2009
CompletedFirst Posted
Study publicly available on registry
June 4, 2009
CompletedApril 22, 2015
April 1, 2015
1.7 years
June 3, 2009
April 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (1)
Group 1
Interventions
Patients in daily life treatment receiving Wellnara according to local drug information.
Eligibility Criteria
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.
You may qualify if:
- Women who have received a prescription of Wellnara on the basis of the decision of the treating gynecologist
You may not qualify if:
- Limited to the criteria listed in the expert information as contraindications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Unknown Facility
Many Locations, Germany
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 3, 2009
First Posted
June 4, 2009
Study Start
September 1, 2007
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
April 22, 2015
Record last verified: 2015-04