Clinical trial NCT00913926: Effects of Wellnara on Climacteric Symptoms
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postmenopause
Keywords: Climacteric symptoms
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 749
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility 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

Primary outcomes:
measure: 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).
timeFrame: At Baseline, after 3 months, after 6 months
Secondary outcomes:
measure: Effects on climacteric-related skin, hair, and sexual problems
timeFrame: At Baseline, after 3 months, after 6 months
measure: Subjective assessment of efficacy
timeFrame: After end of study
measure: Body weight
timeFrame: At Baseline, after 3 months, after 6 months
measure: Blood Pressure
timeFrame: At baseline, end of Study
measure: Waist-hip-ratio (as far as routinely used in the practice)
timeFrame: At baseline, after 6 months
measure: Occurrence of vaginal bleeding
timeFrame: After 3 months, after 6 months
measure: Subjective assessment of tolerability
timeFrame: End of study
measure: Adverse drug reactions
timeFrame: During the whole study
Other outcomes:
Locations:
city: Many Locations
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: