The purpose of this study is to determine whether ovaria comp. is effective in relieving climacteric symptoms

Condition	Intervention	Phase
menopausal symptoms Anxiety Depression	Drug: ovaria comp 10 globuli 3 times per day	Phase IV

Further Study Details: 

Primary Outcomes: Climacteric symptoms measured as the difference of the sum score of the menopause rating scale before and after 12 weeks of treatment
Secondary Outcomes: Climacteric symptoms measured as the difference of the subscales of the menopause rating scale before and after 12 weeks of treatment; Follow-up for another 12 weeks of treatment or after cross-over to the placebo group; Follow-up for cross-over to placebo after 24 weeks of treatment; Diurnal profile of cortisol level before and after treatment phases; Anxiety and depression measured by HADS-D before and after treatment period
Expected Total Enrollment:  90

Complementary treatments for climacteric symptoms are used by many women although their efficacy and safety is mostly unproven.

The use of the complex homeopathic remedy Ovaria comp. for the relief of climacteric symptoms will be examined in this three-armed intervention trial and measured with the menopause rating scale II before and after each study phase of 12 weeks. Participants will receive the verum during two treatment phases of 12 weeks and the placebo during one treatment phase of 12 weeks in different sequences and are stratified for post- and perimenopausal status.

Ages Eligible for Study:  45 Years and above,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Climacteric symptoms>=3 Points in MRS II
• Communication possible

Exclusion Criteria:

• Hormone replacement therapy within 2 weeks prior to study inclusion
• Other complementary treatments 7 days before and during the study
• Climacteric symptoms caused by operation, chemotherapy or hormonal therapy of cancer
• Allergy to components of the remedy, especially bee poison

Please refer to this study by ClinicalTrials.gov identifier  NCT00152776

Julia E Osburg, MD      0049-6221-568324    julia_osburg@med.uni-heidelberg.de
Cornelia U von Hagens, MD      0049-568321    cornelia_von_hagens@med.uni-heidelberg.de

Germany, Baden-Württemberg
      Department of Complementary and Integrative Medicine, Heidelberg,  Baden-Württemberg,  D-69115,  Germany; Recruiting

Study chairs or principal investigators

Cornelia U von Hagens, MD,  Principal Investigator,  University of Heidelberg   

Study ID Numbers:  HD04
Last Updated:  September 8, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00152776
Health Authority: Germany: Ethics Commission; Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13