MenopausePhase 4NCT00152776
Treating Climacteric Symptoms With a Complex Homeopathic Remedy
A Phase 4 study testing ovaria comp 10 globuli 3 times per day 24 weeks in people with Menopause and Anxiety Disorders, run by Heidelberg University at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether ovaria comp. is effective in relieving climacteric symptoms. Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Anxiety Disorders, Depression
- What is being tested?
- ovaria comp 10 globuli 3 times per day 24 weeks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2005to Dec 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Climacteric symptoms>=3 Points in Menopause Rating Scale (MRS) II
- Communication possible
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Complementary and Integrative Medicine
Heidelberg, Baden-Wurttemberg, D-69115
About this study
Official title: Treatment of Climacteric Symptoms With Ovaria Comp - A Prospective Randomized Placebo Controlled Doubleblind Study
The purpose of this study is to determine whether ovaria comp. is effective in relieving climacteric symptoms.
Read the 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.
- Conditions
- Menopause, Anxiety Disorders, Depression
- Being tested
- ovaria comp 10 globuli 3 times per day 24 weeks
- Keywords
- menopausal symptoms, complementary medicine
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ovaria comp 10 globuli 3 times per day 24 weeksDrug
Also called placebo globuli 3 times per day 12 weeks
order of intervention and placebo varies between Groups I-III
| Study group | Role | What they receive |
|---|---|---|
| Group I | Placebo comparator | ovaria comp 10 Globuli 3 times per day 24 weeks - Placebo 12 weeks Receives: Drug: ovaria comp 10 globuli 3 times per day 24 weeks |
| Group II | Placebo comparator | Placebo 12 weeks - ovaria comp 10 globuli 3 times per day 24 weeks Receives: Drug: ovaria comp 10 globuli 3 times per day 24 weeks |
| Group III | Placebo comparator | ovaria comp 10 globuli 3 times per day 12 weeks - Placebo 12 weeks - ovaria comp 10 globuli 3 times per day 12 weeks Receives: Drug: ovaria comp 10 globuli 3 times per day 24 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Climacteric symptoms
sum score of the menopause rating scale (MRS II) before and after 12 weeks of treatment
Measured: 12 weeks
Secondary outcomes (5)
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
Measured: 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
Measured: 12+12 weeks
Follow-up for cross-over to placebo after 24 weeks of treatment
sum score and subscales of the MRS II
Measured: 12+12+12 weeks
Diurnal profile of cortisol level before and after treatment phases
cortisol (saliva: morning, noon, evening)
Measured: 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
Measured: 12+12+12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Wala GmbH
- Responsible party
- Principal investigator, Cornelia von Hagens, Heidelberg University
- Investigators
- Cornelia U von Hagens, MD, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152776
- Sponsor's protocol ID
- HD04
- Status last verified
- Jun 2018
- First submitted
- 8 Sep 2005
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
von Hagens C, Schiller P, Godbillon B, Osburg J, Klose C, Limprecht R, Strowitzki T. Treating menopausal symptoms with a complex remedy or placebo: a randomized controlled trial. Climacteric. 2012 Aug;15(4):358-67. doi: 10.3109/13697137.2011.597895. Epub 2011 Oct 23.
PubMed 22017387
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Climacteric Symptoms With Ovaria Comp - A Prospective Randomized Placebo Controlled Doubleblind Study
- ClinicalTrials.gov ID
- NCT00152776
- Acronym / sponsor ID
- HD04
- Conditions
- Menopause, Anxiety Disorders, Depression
- Keywords
- menopausal symptoms, complementary medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Wala GmbH
- Study start
- Feb 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 9 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether ovaria comp. is effective in relieving climacteric symptoms.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Placebo comparator | Drug: ovaria comp 10 globuli 3 times per day 24 weeksovaria comp 10 Globuli 3 times per day 24 weeks - Placebo 12 weeks |
| Group II | Placebo comparator | Drug: ovaria comp 10 globuli 3 times per day 24 weeksPlacebo 12 weeks - ovaria comp 10 globuli 3 times per day 24 weeks |
| Group III | Placebo comparator | Drug: ovaria comp 10 globuli 3 times per day 24 weeksovaria comp 10 globuli 3 times per day 12 weeks - Placebo 12 weeks - ovaria comp 10 globuli 3 times per day 12 weeks |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Climacteric symptoms>=3 Points in Menopause Rating Scale (MRS) II
- Communication possible
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ovaria comp 10 globuli 3 times per day 24 weeksAlso: placebo globuli 3 times per day 12 weeksorder of intervention and placebo varies between Groups I-III | Drug | Group I, Group II, Group III |
Primary outcome
Climacteric symptoms
Time frame: 12 weeks
sum score of the menopause rating scale (MRS II) before and after 12 weeks of treatment
5 secondary outcomes
Climacteric symptoms (vegetative, psychological, urogenital subscales of the MRS II)
Time frame: 12 weeks
Follow-up for another 12 weeks of treatment or after cross-over to the placebo group
Time frame: 12+12 weeks
Follow-up for cross-over to placebo after 24 weeks of treatment
Time frame: 12+12+12 weeks
Diurnal profile of cortisol level before and after treatment phases
Time frame: 12+12+12 weeks
Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS-D) before and after treatment period
Time frame: 12+12+12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
- Results publication: PubMed 22017387von Hagens C, Schiller P, Godbillon B, Osburg J, Klose C, Limprecht R, Strowitzki T. Treating menopausal symptoms with a complex remedy or placebo: a randomized controlled trial. Climacteric. 2012 Aug;15(4):358-67. doi: 10.3109/13697137.2011.597895. Epub 2011 Oct 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cornelia U von Hagens, MD principal investigator
Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ovaria comp 10 globuli 3 times per day 24 weeks in people with Menopause and Anxiety Disorders, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Climacteric symptoms (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00152776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2018; AzTrials last refreshed its copy on 1 Nov 2026.