Climacteric Clinical Trial : the Use of Complementary Therapy and Hormonal Replacement

Climacteric Clinical Trial

Official title:

Climacteric Clinical Trial : the Use of Complementary Therapy and Hormonal Replacement

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00617500
• Other study ID #: SHS 18/07
• Status: Unknown status
• Phase: Phase 4
• First received: January 23, 2008
• Last updated: September 18, 2009
• Start date: July 2008
• Est. completion date: November 2009

Study information

• Verified date: September 2009
• Source: Sociedade Hospital Samaritano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 . 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 278
• Est. completion date: November 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Climacteric

Intervention

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
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 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.

Drug:
• Hormones
Estradiol 1 mg and a drospirenone 2mg/day (3 months)

Locations

Country	Name	City	State
Brazil	Hospital Samaritano	São Paulo
Brazil	Nursing School of University of São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Sociedade Hospital Samaritano	University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	annoying signs and climacteric symptoms		pre and post intervention