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Effects of Wellnara on Climacteric Symptoms

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00913926
First Posted: June 4, 2009
Last Update Posted: April 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bayer
  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: Multicenter Non-interventional Study on Efficacy, Tolerability, and Acceptance of Wellnara Containing 1.03 mg Estradiol Hemihydrate (Equivalent to 1 mg Estradiol) and 0.04 mg Levonorgestrel for Treatment of Hormone Deficiency Symptoms in Postmenopausal Women During 6 Cycles of 28 Days.

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 ]

Secondary Outcome Measures:
  • Effects on climacteric-related skin, hair, and sexual problems [ Time Frame: At Baseline, after 3 months, after 6 months ]
  • Subjective assessment of efficacy [ Time Frame: After end of study ]
  • Body weight [ Time Frame: At Baseline, after 3 months, after 6 months ]
  • Blood Pressure [ Time Frame: At baseline, end of Study ]
  • Waist-hip-ratio (as far as routinely used in the practice) [ Time Frame: At baseline, after 6 months ]
  • Occurrence of vaginal bleeding [ Time Frame: After 3 months, after 6 months ]
  • Subjective assessment of tolerability [ Time Frame: End of study ]
  • Adverse drug reactions [ Time Frame: During the whole study ]

Enrollment: 749
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913926


Locations
Germany
Many Locations, Germany
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Medical Director, Jenapharm GmbH&Co.KG
ClinicalTrials.gov Identifier: NCT00913926     History of Changes
Other Study ID Numbers: 14575
WN0810DE ( Other Identifier: Company Internal )
First Submitted: June 3, 2009
First Posted: June 4, 2009
Last Update Posted: April 22, 2015
Last Verified: April 2015

Keywords provided by Bayer:
Climacteric symptoms