MedTrace Logo

Effects of Wellnara on Climacteric Symptoms

NCT00913926 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 749

Last updated 2015-04-22

No results posted yet for this study

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.

Conditions

  • Postmenopause

Interventions

DRUG

E2/LNG oral (Wellnara, BAY86-5029)

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • Germany

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00913926 on ClinicalTrials.gov