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Completed

NCT Number: NCT00152776

Treating Climacteric Symptoms With a Complex Homeopathic Remedy

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

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Key information

Conditions

Menopause Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Complementary and Integrative Medicine

Heidelberg, Baden-Wurttemberg, D-69115, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ovaria comp 10 globuli 3 times per day 24 weeks

Drug

order of intervention and placebo varies between Groups I-III

Other names: placebo globuli 3 times per day 12 weeks

Primary outcomes

  1. Climacteric symptoms

    Time frame: 12 weeks

    sum score of the menopause rating scale (MRS II) before and after 12 weeks of treatment

Secondary outcomes

  1. Climacteric symptoms (vegetative, psychological, urogenital subscales of the MRS II)

    Time frame: 12 weeks

    difference of the subscales of the menopause rating scale before and after 12 weeks of treatment

  2. Follow-up for another 12 weeks of treatment or after cross-over to the placebo group

    Time frame: 12+12 weeks

    sum score and subscales of the MRS II

  3. Follow-up for cross-over to placebo after 24 weeks of treatment

    Time frame: 12+12+12 weeks

    sum score and subscales of the MRS II

  4. Diurnal profile of cortisol level before and after treatment phases

    Time frame: 12+12+12 weeks

    cortisol (saliva: morning, noon, evening)

  5. Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS-D) before and after treatment period

    Time frame: 12+12+12 weeks

    Hospital Anxiety and Depression Scale

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Collaborators

  • Wala GmbH

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 9, 2005
Registry last updated
Jun 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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