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NCT00913926 Clinical Trial

Effects of Wellnara on Climacteric Symptoms

Postmenopause Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00913926
Other study ID # 14575
Secondary ID WN0810DE
Status Completed
Phase N/A
First received June 3, 2009
Last updated April 21, 2015
Start date September 2007
Est. completion date May 2009

Study information
Verified date April 2015
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 749
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• E2/LNG oral (Wellnara, BAY86-5029)
Patients in daily life treatment receiving Wellnara according to local drug information.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Effects on climacteric-related skin, hair, and sexual problems At Baseline, after 3 months, after 6 months No
Secondary Subjective assessment of efficacy After end of study No
Secondary Body weight At Baseline, after 3 months, after 6 months Yes
Secondary Blood Pressure At baseline, end of Study Yes
Secondary Waist-hip-ratio (as far as routinely used in the practice) At baseline, after 6 months Yes
Secondary Occurrence of vaginal bleeding After 3 months, after 6 months Yes
Secondary Subjective assessment of tolerability End of study Yes
Secondary Adverse drug reactions During the whole study Yes
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