ClimactericPhase 4NCT00617500
Climacteric Clinical Trial : the Use of Complementary Therapy and Hormonal Replacement
A Phase 4 study testing flower therapy, therapeutic touch and auricular therapy in people with Climacteric, run by Sociedade Hospital Samaritano at 2 sites in Brazil.
Trial summary
The alternative and complementary therapies are being gradually included in the Brazilian Health Unique System (SUS), as it is foreseen in the National Politics of Integrative and Complementary Practices in Brazil . Read more about this study
- Who is it for?
- Ages 45 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Climacteric
- What is being tested?
- flower therapy, therapeutic touch and auricular therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 2 sitesBrazil
- Study dates
- Jul 2008to Nov 2009
- 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 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Recruited and registered in local of the study
- They should present the signs and symptoms checked - insomnia, anxiety and hot flushes, they felt at the beginning of the climacteric
- They should not be under hormonal replacement or even should have stopped their use more than 90 days
Who cannot join
- women who undergo a hysterectomy surgery
- women using hormonal therapy
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital Samaritano
São Paulo, São Paulo, 01232-010
Nursing School of University of São Paulo
São Paulo, São Paulo, 01232-010
About this study
The alternative and complementary therapies are being gradually included in the Brazilian Health Unique System (SUS), as it is foreseen in the National Politics of Integrative and Complementary Practices in Brazil . However, though this thematic is also included in the National Agenda of Research Priorities concerning Health, published studies concerning this matter are quite scarce. The World Health Organization (WHO) indicated that it is a big challenge to effect the following studies: cost-effectiveness, as well as safety, efficiency and the quality of such practices. WHO also pointed out the clinical situations where they could be applied and that is why this investigation we are undertaken is fully justified.
Annoying signs and symptoms which come along with the climacteric period, especially anxiety, insomnia and hot flushes, change women´s life quality and their affective, social and business relationships as well. Consequently, this can generate sadness, depression and isolation.
Read more
Many women cannot undergo hormonal replacement, for several reasons: or they have some illnesses which reject hormones, or due to hypersensitiveness reactions or even economical difficulties. Also, the cost-effectiveness ratio between conventional therapy of hormonal replacement and complementary therapies which compose this study are not known yet .
The complementary therapies proposed in this study concern non-invasive methods, of low cost, which justify being researched in order to verify the potential of those annoying signs alleviation.
- Conditions
- Climacteric
- Being tested
- flower therapy, therapeutic touch, auricular therapy, Hormones
- Keywords
- climacteric, complementary therapy, hormonal replacement therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flower therapyOther
Each woman will perform 12 sessions of 20 to 30 minutes, depending on the treatment group, with weekly intervals performed in one of the consultation rooms.
therapeutic touchOther
Each woman will perform 12 sessions of 20 to 30 minutes, depending on the treatment group, with weekly intervals performed in one of the consultation rooms.
auricular therapyOther
Each woman will perform 12 sessions of 20 to 30 minutes, depending on the treatment group, with weekly intervals performed in one of the consultation rooms.
HormonesDrug
Estradiol 1 mg and a drospirenone 2mg/day (3 months)
| Study group | Role | What they receive |
|---|---|---|
| Hormone | Active comparator | Not described Receives: Drug: Hormones |
| flower therapy | Experimental | Not described Receives: Other: flower therapy |
| therapeutic touch | Experimental | Not described Receives: Other: therapeutic touch |
| auriculotherapy | Experimental | Not described Receives: Other: auricular therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
annoying signs and climacteric symptoms
Measured: pre and post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2008 (estimated)
- Study completionNov 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClimactericStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sociedade Hospital Samaritano
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Investigators
- Eliseth R Leão, PhD, Study director, Hospital SamaritanoMaria Julia P Silva, PhD, Study director, University of Sao PauloLéia Sales, MscN, Principal investigator, University of Sao PauloIvaldo da Silva, PhD, Principal investigator, Tocogynecological Department of São Paulo Federal UniversityMaria C Martinez, PhD, Principal investigator, Hospital Samaritano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617500
- Sponsor's protocol ID
- SHS 18/07
- Status last verified
- Sep 2009
- First submitted
- 23 Jan 2008
- Last updated
- 22 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Climacteric Clinical Trial : the Use of Complementary Therapy and Hormonal Replacement
- ClinicalTrials.gov ID
- NCT00617500
- Acronym / sponsor ID
- SHS 18/07
- Conditions
- Climacteric
- Keywords
- climacteric, complementary therapy, hormonal replacement therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- Sociedade Hospital SamaritanoUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- Jul 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Nov 2009 (estimated)
- First posted
- 18 Feb 2008 (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 alternative and complementary therapies are being gradually included in the Brazilian Health Unique System (SUS), as it is foreseen in the National Politics of Integrative and Complementary Practices in Brazil . However, though this thematic is also included in the National Agenda of Research Priorities concerning Health, published studies concerning this matter are quite scarce. The World Health Organization (WHO) indicated that it is a big challenge to effect the following studies: cost-effectiveness, as well as safety, efficiency and the quality of such practices. WHO also pointed out the clinical situations where they could be applied and that is why this investigation we are undertaken is fully justified.
Annoying signs and symptoms which come along with the climacteric period, especially anxiety, insomnia and hot flushes, change women´s life quality and their affective, social and business relationships as well. Consequently, this can generate sadness, depression and isolation.
Many women cannot undergo hormonal replacement, for several reasons: or they have some illnesses which reject hormones, or due to hypersensitiveness reactions or even economical difficulties. Also, the cost-effectiveness ratio between conventional therapy of hormonal replacement and complementary therapies which compose this study are not known yet .
The complementary therapies proposed in this study concern non-invasive methods, of low cost, which justify being researched in order to verify the potential of those annoying signs alleviation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hormone | Active comparator | Drug: Hormones |
| flower therapy | Experimental | Other: flower therapy |
| therapeutic touch | Experimental | Other: therapeutic touch |
| auriculotherapy | Experimental | Other: auricular therapy |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female
- Recruited and registered in local of the study
- They should present the signs and symptoms checked - insomnia, anxiety and hot flushes, they felt at the beginning of the climacteric
- They should not be under hormonal replacement or even should have stopped their use more than 90 days
Key exclusion criteria (2 listed)
- women who undergo a hysterectomy surgery
- women using hormonal therapy
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 |
|---|---|---|
| flower therapyEach woman will perform 12 sessions of 20 to 30 minutes, depending on the treatment group, with weekly intervals performed in one of the consultation rooms. | Other | flower therapy |
| therapeutic touchEach woman will perform 12 sessions of 20 to 30 minutes, depending on the treatment group, with weekly intervals performed in one of the consultation rooms. | Other | therapeutic touch |
| auricular therapyEach woman will perform 12 sessions of 20 to 30 minutes, depending on the treatment group, with weekly intervals performed in one of the consultation rooms. | Other | auriculotherapy |
| HormonesEstradiol 1 mg and a drospirenone 2mg/day (3 months) | Drug | Hormone |
Primary outcome
annoying signs and climacteric symptoms
Time frame: pre and post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2009.
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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.
Eliseth R Leão, PhD study director
Hospital Samaritano
Maria Julia P Silva, PhD study director
University of Sao Paulo
Léia Sales, MscN principal investigator
University of Sao Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing flower therapy, therapeutic touch and auricular therapy in people with Climacteric, run by Sociedade Hospital Samaritano at 2 sites in Brazil.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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. 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?
Results are not available in the source record.
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?
annoying signs and climacteric symptoms (time frame: pre and post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2009.