NCT00913926

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
• Phase: —
• Study type: Observational
• Enrollment: 749 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Postmenopause

Interventions

Type	Name	Description
DRUG	E2/LNG oral (Wellnara, BAY86-5029)	Patients in daily life treatment receiving Wellnara according to local drug information.

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2009-06-04
• Last updated: 2015-04-22

Locations

1 site across 1 country: Germany