Treating Climacteric Symptoms With a Complex Homeopathic Remedy

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

Detailed Description
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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.

Official Title
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Treatment of Climacteric Symptoms With Ovaria Comp - A Prospective Randomized Placebo Controlled Doubleblind Study

Conditions
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Menopause, Anxiety Disorders, Depression

Intervention / Treatment
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* Drug: ovaria comp 10 globuli 3 times per day 24 weeks


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group I<br>ovaria comp 10 Globuli 3 times per day 24 weeks - Placebo 12 weeks | Drug: ovaria comp 10 globuli 3 times per day 24 weeks<br>* order of intervention and placebo varies between Groups I-III<br>* Other names: placebo globuli 3 times per day 12 weeks;|
| Placebo Comparator: Group II<br>Placebo 12 weeks - ovaria comp 10 globuli 3 times per day 24 weeks | Drug: ovaria comp 10 globuli 3 times per day 24 weeks<br>* order of intervention and placebo varies between Groups I-III<br>* Other names: placebo globuli 3 times per day 12 weeks;|
| Placebo Comparator: Group III<br>ovaria comp 10 globuli 3 times per day 12 weeks - Placebo 12 weeks - ovaria comp 10 globuli 3 times per day 12 weeks | Drug: ovaria comp 10 globuli 3 times per day 24 weeks<br>* order of intervention and placebo varies between Groups I-III<br>* Other names: placebo globuli 3 times per day 12 weeks;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Climacteric symptoms | sum score of the menopause rating scale (MRS II) before and after 12 weeks of treatment | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Climacteric symptoms (vegetative, psychological, urogenital subscales of the MRS II) | difference of the subscales of the menopause rating scale before and after 12 weeks of treatment | 12 weeks | 
| Follow-up for another 12 weeks of treatment or after cross-over to the placebo group | sum score and subscales of the MRS II | 12+12 weeks | 
| Follow-up for cross-over to placebo after 24 weeks of treatment | sum score and subscales of the MRS II | 12+12+12 weeks | 
| Diurnal profile of cortisol level before and after treatment phases | cortisol (saliva: morning, noon, evening) | 12+12+12 weeks | 
| Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS-D) before and after treatment period | Hospital Anxiety and Depression Scale | 12+12+12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menopausal symptoms, complementary medicine