check_circleStudy Completed
Postmenopause
Bayer Identifier:
14575
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Effects of Wellnara on climacteric symptoms
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.
Key Participants Requirements
Sex
FemaleAge
0 - N/ATrial summary
Enrollment Goal
749Trial Dates
September 2007 - May 2009Phase
N/ACould I Receive a placebo
NoProducts
Wellnara (E2/LNG oral, BAY86-5029)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Germany |
Primary Outcome
- 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).date_rangeTime Frame:At Baseline, after 3 months, after 6 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Effects on climacteric-related skin, hair, and sexual problemsdate_rangeTime Frame:At Baseline, after 3 months, after 6 monthsenhanced_encryptionNoSafety Issue:
- Subjective assessment of efficacydate_rangeTime Frame:After end of studyenhanced_encryptionNoSafety Issue:
- Body weightdate_rangeTime Frame:At Baseline, after 3 months, after 6 monthsenhanced_encryptionYesSafety Issue:
- Blood Pressuredate_rangeTime Frame:At baseline, end of Studyenhanced_encryptionYesSafety Issue:
- Waist-hip-ratio (as far as routinely used in the practice)date_rangeTime Frame:At baseline, after 6 monthsenhanced_encryptionYesSafety Issue:
- Occurrence of vaginal bleedingdate_rangeTime Frame:After 3 months, after 6 monthsenhanced_encryptionYesSafety Issue:
- Subjective assessment of tolerabilitydate_rangeTime Frame:End of studyenhanced_encryptionYesSafety Issue:
- Adverse drug reactionsdate_rangeTime Frame:During the whole studyenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A