The Effects of Isoflavone and Estrogen in Sex Response in Climacteric Women

NCT ID: NCT00905723

Last Updated: 2009-05-20

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Brief Summary

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Climacterium is marked by hypoestrogenism and it is associated to drastic vasomotors symptoms, genital atrophy and humor alteration. Additionally, these symptoms impair sexual life and life quality. These effects can be counteracted by administration of estrogen therapy. However, estrogen therapy has side effects and isoflavone has been proposed as an estrogen substitute in reposition therapy. The aim of the randomized controlled trial is to evaluate the effects of isoflavone in the sex life assessed by a modified McCoy's sexual questionnaire.

Detailed Description

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Conditions

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Postmenopausal Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Estrogen

Women randomized to this group will receive daily pills containing 1 mg of estradiol

Group Type EXPERIMENTAL

estradiol

Intervention Type DRUG

1 mg daily for 6 months

Isoflavone

Women randomized to this group will receive daily pills of 150 mg isoflavone

Group Type EXPERIMENTAL

isoflavone

Intervention Type DRUG

150 mg isoflavone daily for 6 months

Placebo

Women randomized to this group will be administered daily placebo pills

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

sugar pill daily for six months

Interventions

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estradiol

1 mg daily for 6 months

Intervention Type DRUG

isoflavone

150 mg isoflavone daily for 6 months

Intervention Type DRUG

Placebo

sugar pill daily for six months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* women aged 45-65 years old
* presenting climacteric symptoms
* sexual complaints

Exclusion Criteria

* hormonal therapy
* counter indication to hormonal therapy
* uncontrolled comorbidities
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Universidade Federal de São Paulo - Departamento de Ginecologia

Principal Investigators

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Mauro A Aidar, M.D., PhD

Role: STUDY_CHAIR

Universidade Federal de São Paulo

Locations

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Ambulatório de Ginecologia Endócrina

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Teresa R Embiruçu, M.D.

Role: CONTACT

5511-75413521

Regiane HB Rabelo, M.D.

Role: CONTACT

5511-72307128

Facility Contacts

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Maria Cecília Santos, Nurse

Role: primary

5511-55496174

Related Links

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http://www.unifesp.br

Universidade Federal de São Paulo's web page

Other Identifiers

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0759/08

Identifier Type: -

Identifier Source: org_study_id

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