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

May 19, 2009 updated by: Federal University of São Paulo

Effects of Isoflavone and Estrogen in Sex Response in Climacteric Women

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • São Paulo, Brazil, 04039-060
        • Recruiting
        • Ambulatório de Ginecologia Endócrina
        • Principal Investigator:
          • Teresa R Embiruçu, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • hormonal therapy
  • counter indication to hormonal therapy
  • uncontrolled comorbidities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Estrogen
Women randomized to this group will receive daily pills containing 1 mg of estradiol
Drug: estradiol
1 mg daily for 6 months
EXPERIMENTAL: Isoflavone
Women randomized to this group will receive daily pills of 150 mg isoflavone
Drug: isoflavone
150 mg isoflavone daily for 6 months
PLACEBO_COMPARATOR: Placebo
Women randomized to this group will be administered daily placebo pills
Drug: Placebo
sugar pill daily for six months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
McCoy's sexual questionnaire
Time Frame: at recruitment and six months later
at recruitment and six months later

Secondary Outcome Measures

Outcome Measure
Time Frame
Kupperman's index
Time Frame: at recruitment and six months later
at recruitment and six months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Study Chair: Mauro A Aidar, M.D., PhD, Universidade Federal de Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ANTICIPATED)

May 1, 2010

Study Registration Dates

First Submitted

May 19, 2009

First Submitted That Met QC Criteria

May 19, 2009

First Posted (ESTIMATE)

May 20, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 20, 2009

Last Update Submitted That Met QC Criteria

May 19, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0759/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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