Clinical trial NCT00617500: Climacteric Clinical Trial : the Use of Complementary Therapy and Hormonal Replacement
Official title: Climacteric Clinical Trial : the Use of Complementary Therapy and Hormonal Replacement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Climacteric
Keywords: climacteric
complementary therapy
hormonal replacement therapy
Lead sponsor: Sociedade Hospital Samaritano
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2008-02-18
Enrollment: 278
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 . 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion criteria:

* women who undergo a hysterectomy surgery
* women using hormonal therapy

Primary outcomes:
measure: annoying signs and climacteric symptoms
timeFrame: pre and post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Samaritano
city: São Paulo
country: Brazil
facility: Nursing School of University of São Paulo
Study officials:
affiliation: Hospital Samaritano
name: Eliseth R Leão, PhD
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo
name: Maria Julia P Silva, PhD
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo
name: Léia Sales, MscN
role: PRINCIPAL_INVESTIGATOR
affiliation: Tocogynecological Department of São Paulo Federal University
name: Ivaldo da Silva, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Samaritano
name: Maria C Martinez, PhD
role: PRINCIPAL_INVESTIGATOR
References: