Effects of Wellnara on Climacteric Symptoms

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00913926
First received: June 3, 2009
Last updated: November 1, 2011
Last verified: November 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 31, 2014