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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Federal University of São Paulo.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00905723
First Posted: May 20, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federal University of São Paulo
  Purpose
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.

Condition Intervention Phase
Postmenopausal Symptoms Drug: estradiol Drug: isoflavone Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Isoflavone and Estrogen in Sex Response in Climacteric Women

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • McCoy's sexual questionnaire [ Time Frame: at recruitment and six months later ]

Secondary Outcome Measures:
  • Kupperman's index [ Time Frame: at recruitment and six months later ]

Estimated Enrollment: 60
Study Start Date: May 2009
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • hormonal therapy
  • counter indication to hormonal therapy
  • uncontrolled comorbidities
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905723


Contacts
Contact: Teresa R Embiruçu, M.D. 5511-75413521 embirucu2@yahoo.com.br
Contact: Regiane HB Rabelo, M.D. 5511-72307128 gianehelena@ig.com.br

Locations
Brazil
Ambulatório de Ginecologia Endócrina Recruiting
São Paulo, Brazil, 04039-060
Contact: Maria Cecília Santos, Nurse    5511-55496174    mc.santos@hotmail.com   
Principal Investigator: Teresa R Embiruçu, M.D         
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Chair: Mauro A Aidar, M.D., PhD Universidade Federal de São Paulo
  More Information

Additional Information:
Responsible Party: Teresa Raquel Embiruçu de Araújo, Universidade Federal de São Paulo - Departamento de Ginecologia
ClinicalTrials.gov Identifier: NCT00905723     History of Changes
Other Study ID Numbers: 0759/08
First Submitted: May 19, 2009
First Posted: May 20, 2009
Last Update Posted: October 12, 2017
Last Verified: May 2009

Keywords provided by Federal University of São Paulo:
climacterium
sexual life
isoflavone
estrogen
McCoy's sexual questionnaire
Kupperman index

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Estrogens
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female