Effects of Wellnara on Climacteric Symptoms - Full Text View

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.

Condition	Intervention
Postmenopause	Drug: E2/LNG oral (Wellnara, BAY86-5029)

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Effects of Wellnara on Climacteric Symptoms

Resource links provided by NLM:

MedlinePlus related topics: Menopause

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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). [ Time Frame: At Baseline, after 3 months, after 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Enrollment:	748
Study Start Date:	September 2007
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1	Drug: E2/LNG oral (Wellnara, BAY86-5029) Patients in daily life treatment receiving Wellnara according to local drug information.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913926

Locations

Germany

Many Locations, Germany

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical Director, Jenapharm GmbH&Co.KG
ClinicalTrials.gov Identifier:	NCT00913926 History of Changes
Other Study ID Numbers:	14575, WN0810DE
Study First Received:	June 3, 2009
Last Updated:	November 1, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Climacteric symptoms

ClinicalTrials.gov processed this record on May 21, 2013