check_circleStudy Completed

Postmenopause

Bayer Identifier:

14575

ClinicalTrials.gov Identifier:

NCT00913926

EudraCT Number:

Not Available

EU CT Number:

Not Available
Effects of Wellnara on climacteric symptoms

Trial 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.

Key Participants Requirements

Sex

Female

Age

0 - N/A


  • - Women who have received a prescription of Wellnara on the basis of the decision of the treating gynecologist


  • - Limited to the criteria listed in the expert information as contraindications

Trial summary

Enrollment Goal
749
Trial Dates
September 2007 - May 2009
Phase
N/A
Could I Receive a placebo
No
Products
Wellnara (E2/LNG oral, BAY86-5029)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Germany

Primary Outcome

  • 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).
    date_rangeTime Frame:
    At Baseline, after 3 months, after 6 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Effects on climacteric-related skin, hair, and sexual problems
    date_rangeTime Frame:
    At Baseline, after 3 months, after 6 months
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    Safety Issue:
    No
  • Subjective assessment of efficacy
    date_rangeTime Frame:
    After end of study
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    Safety Issue:
    No
  • Body weight
    date_rangeTime Frame:
    At Baseline, after 3 months, after 6 months
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    Safety Issue:
    Yes
  • Blood Pressure
    date_rangeTime Frame:
    At baseline, end of Study
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    Safety Issue:
    Yes
  • Waist-hip-ratio (as far as routinely used in the practice)
    date_rangeTime Frame:
    At baseline, after 6 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Occurrence of vaginal bleeding
    date_rangeTime Frame:
    After 3 months, after 6 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Subjective assessment of tolerability
    date_rangeTime Frame:
    End of study
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    Safety Issue:
    Yes
  • Adverse drug reactions
    date_rangeTime Frame:
    During the whole study
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    Safety Issue:
    Yes

Trial design

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.
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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