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Effects of Wellnara on Climacteric Symptoms

NCT ID: NCT00913926

Last Updated: 2015-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

749 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Postmenopause

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

E2/LNG oral (Wellnara, BAY86-5029)

Intervention Type DRUG

Patients in daily life treatment receiving Wellnara according to local drug information.

Interventions

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E2/LNG oral (Wellnara, BAY86-5029)

Patients in daily life treatment receiving Wellnara according to local drug information.

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Jenapharm GmbH&Co.KG

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Germany

Site Status

Countries

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Germany

Other Identifiers

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WN0810DE

Identifier Type: OTHER

Identifier Source: secondary_id

14575

Identifier Type: -

Identifier Source: org_study_id

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