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OpenTrials
Completed

NCT Number: NCT00913926

Effects of Wellnara on Climacteric Symptoms

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.

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Key information

Conditions

Postmenopause

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

E2/LNG oral (Wellnara, BAY86-5029)

Drug

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

Primary outcomes

  1. 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 outcomes

  1. Effects on climacteric-related skin, hair, and sexual problems

    Time frame: At Baseline, after 3 months, after 6 months

  2. Subjective assessment of efficacy

    Time frame: After end of study

  3. Body weight

    Time frame: At Baseline, after 3 months, after 6 months

  4. Blood Pressure

    Time frame: At baseline, end of Study

  5. Waist-hip-ratio (as far as routinely used in the practice)

    Time frame: At baseline, after 6 months

  6. Occurrence of vaginal bleeding

    Time frame: After 3 months, after 6 months

  7. Subjective assessment of tolerability

    Time frame: End of study

  8. Adverse drug reactions

    Time frame: During the whole study

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jun 4, 2009
Registry last updated
Apr 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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