Trial Condition(s):
Postmenopause
Effects of Wellnara on climacteric symptoms
Bayer Identifier:
14575
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Germany | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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.
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
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).Timeframe: At Baseline, after 3 months, after 6 months
Secondary Outcome
- Effects on climacteric-related skin, hair, and sexual problemsTimeframe: At Baseline, after 3 months, after 6 months
- Subjective assessment of efficacyTimeframe: After end of study
- Body weightTimeframe: At Baseline, after 3 months, after 6 months
- Blood PressureTimeframe: At baseline, end of Study
- Waist-hip-ratio (as far as routinely used in the practice)Timeframe: At baseline, after 6 months
- Occurrence of vaginal bleedingTimeframe: After 3 months, after 6 months
- Subjective assessment of tolerabilityTimeframe: End of study
- Adverse drug reactionsTimeframe: During the whole study
Additional Information
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