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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00617500
Enrollment
278
Registered
2008-02-18
Start date
2008-07-31
Completion date
2009-11-30
Last updated
2009-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Climacteric

Keywords

climacteric, complementary therapy, hormonal replacement therapy

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.

Interventions

OTHERflower 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.

OTHERtherapeutic 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.

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.

DRUGHormones

Estradiol 1 mg and a drospirenone 2mg/day (3 months)

Sponsors

University of Sao Paulo
CollaboratorOTHER
Sociedade Hospital Samaritano
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
annoying signs and climacteric symptomspre and post intervention

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026