Effects of Wellnara on Climacteric Symptoms

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00913926
• Collaborator: (none)
• Enrollment: 749
• Location: 1
• Duration (Months): 20
• Patients Per Site Per Month: 37.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postmenopause	Drug: E2/LNG oral (Wellnara, BAY86-5029)

Study Design

• Study Type: Observational
• Actual Enrollment: 749 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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 Start Date: Sep 1, 2007
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Group 1	Drug: E2/LNG oral (Wellnara, BAY86-5029); Patients in daily life treatment receiving Wellnara according to local drug information.

Outcome Measures

Primary Outcome Measures

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). [At Baseline, after 3 months, after 6 months]

Secondary Outcome Measures

1. Effects on climacteric-related skin, hair, and sexual problems [At Baseline, after 3 months, after 6 months]

2. Subjective assessment of efficacy [After end of study]

3. Body weight [At Baseline, after 3 months, after 6 months]

4. Blood Pressure [At baseline, end of Study]

5. Waist-hip-ratio (as far as routinely used in the practice) [At baseline, after 6 months]

6. Occurrence of vaginal bleeding [After 3 months, after 6 months]

7. Subjective assessment of tolerability [End of study]

8. Adverse drug reactions [During the whole study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Many Locations		Germany

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00913926
• Other Study ID Numbers: 14575; WN0810DE
• First Posted: Jun 4, 2009
• Last Update Posted: Apr 22, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by , ,: Climacteric symptoms

Study Results

No Results Posted as of Apr 22, 2015