Effects of Wellnara on Climacteric Symptoms

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00913926

Enrollment

749

Registered

2009-06-04

Start date

2007-09-30

Completion date

2009-05-31

Last updated

2015-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopause

Keywords

Climacteric symptoms

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.

Interventions

DRUGE2/LNG oral (Wellnara, BAY86-5029)

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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).	At Baseline, after 3 months, after 6 months

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026