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Effects of Wellnara on Climacteric Symptoms

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Bayer

Status

Completed

Conditions

Postmenopause

Treatments

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

Study type

Observational

Funder types

Industry

Identifiers

NCT00913926
14575
WN0810DE (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

749 patients

Sex

Female

Volunteers

No Healthy Volunteers

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 design

749 participants in 1 patient group

Group 1
Treatment:
Drug: E2/LNG oral (Wellnara, BAY86-5029)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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