Treating Climacteric Symptoms With a Complex Homeopathic Remedy - Full Text View

Sponsors and Collaborators:	University of Heidelberg Wala GmbH
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00152776

Purpose

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

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

MedlinePlus related topics: Anxiety Depression Menopause

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Treatment of Climacteric Symptoms With Ovaria Comp - A Prospective Randomized Placebo Controlled Doubleblind Study

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:

Climacteric symptoms measured as the difference of the sum score of the menopause rating scale before and after 12 weeks of treatment

Secondary Outcome Measures:

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 Hospital Anxiety and Depression Scale (HADS-D) before and after treatment period

Estimated Enrollment:	102
Study Start Date:	February 2005
Study Completion Date:	December 2006

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Climacteric symptoms>=3 Points in Menopause Rating Scale (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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152776

Locations

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

Sponsors and Collaborators

University of Heidelberg

Wala GmbH

Investigators

Principal Investigator:

Cornelia U von Hagens, MD

University of Heidelberg

More Information

Study ID Numbers:	HD04
Study First Received:	September 8, 2005
Last Updated:	April 18, 2007
ClinicalTrials.gov Identifier:	NCT00152776
Health Authority:	Germany: Ethics Commission; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Heidelberg:

menopausal symptoms
complementary medicine

Study placed in the following topic categories:

Depression
Anxiety Disorders
Mental Disorders

Depressive Disorder
Menopause
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 16, 2009