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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

TRANSDERMAL HRT RELIEVING POSTMENOPAUSAL SYMPTOMS

NCT02033512

Menopause

COMPLETED PHASE2

Profile of Brazilian Climacteric Women: the Brazilian Menopause Study

NCT06872385

Menopause

COMPLETED

Integrative Health Care Model for Climacteric Stage Women

NCT01272115

State; Climacteric

COMPLETED NA

Efficacy and Safety for Cimicifuga/Hypericum Product

NCT01481025

Perimenopausal Disorder

UNKNOWN PHASE3

Pharmacokinetic Aspects of 25-mg Estradiol Pellet in Climacteric Women

NCT06136208

Climacteric Syndrome Menopause Hypoestrogenism

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Climacteric

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hormone

Group Type ACTIVE_COMPARATOR

Hormones

Intervention Type DRUG

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