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Climacteric Clinical Trial : the Use of Complementary Therapy and Hormonal Replacement
This study is currently recruiting participants.
Verified by Sociedade Hospital Samaritano, February 2009
First Received: January 23, 2008   Last Updated: February 25, 2009   History of Changes
Sponsors and Collaborators: Sociedade Hospital Samaritano
University of Sao Paulo
Information provided by: Sociedade Hospital Samaritano
ClinicalTrials.gov Identifier: NCT00617500
  Purpose

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.


Condition Intervention
Climacteric
Other: flower therapy
Other: therapeutic touch
Other: auricular therapy
Drug: Hormones

MedlinePlus related topics: Complementary and Alternative Medicine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Parallel Assignment, Efficacy Study
Official Title: Climacteric Clinical Trial : the Use of Complementary Therapy and Hormonal Replacement

Further study details as provided by Sociedade Hospital Samaritano:

Primary Outcome Measures:
  • annoying signs and climacteric symptoms [ Time Frame: pre and post intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 278
Study Start Date: July 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Hormone: Active Comparator Drug: Hormones
Estradiol 1 mg and a drospirenone 2mg/day (3 months)
flower therapy: Experimental Other: flower therapy
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 touch: Experimental Other: therapeutic touch
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.
auriculotherapy: Experimental Other: auricular therapy
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.

  Eligibility

Ages Eligible for Study:   45 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00617500

Contacts
Contact: Eliseth R Leão, PhD 55 11 38215891 eliseth.leao@samaritano.org.br

Locations
Brazil
Hospital Samaritano Recruiting
São Paulo, Brazil, 01232-010
Contact: Eliseth R Leão, PhD     55 11 38215891     eliseth.leao@samaritano.org.br    
Principal Investigator: Eliseth R Leão, PhD            
Sub-Investigator: Maria Julia P Silva, PhD            
Nursing School of University of São Paulo Recruiting
São Paulo, Brazil, 01232-010
Contact: Maria Julia P Silva, PhD     55 11 30617544     juliaps@usp.br    
Principal Investigator: Eliseth R Leão, PhD            
Sub-Investigator: Maria Julia P Silva, PhD            
Sponsors and Collaborators
Sociedade Hospital Samaritano
University of Sao Paulo
Investigators
Study Director: Eliseth R Leão, PhD Hospital Samaritano
Study Director: Maria Julia P Silva, PhD University of São Paulo
Principal Investigator: Léia Sales, MscN University of São Paulo
Principal Investigator: Ivaldo da Silva, PhD Tocogynecological Department of São Paulo Federal University
Principal Investigator: Maria C Martinez, PhD Hospital Samaritano
  More Information

No publications provided

Responsible Party: Scientific Research Department of Samaritano Hospital ( Eliseth Ribeiro Leão )
Study ID Numbers: SHS 18/07
Study First Received: January 23, 2008
Last Updated: February 25, 2009
ClinicalTrials.gov Identifier: NCT00617500     History of Changes
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Sociedade Hospital Samaritano:
climacteric
complementary therapy
hormonal replacement therapy

Study placed in the following topic categories:
Estradiol 3-benzoate
Estradiol valerate
Drospirenone
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Hormones
Estradiol

ClinicalTrials.gov processed this record on May 07, 2009