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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Federal University of São Paulo.
Recruitment status was  Recruiting
Information provided by:
Federal University of São Paulo Identifier:
First received: May 19, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Isoflavone and Estrogen in Sex Response in Climacteric Women

Resource links provided by NLM:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Kupperman's index [ Time Frame: at recruitment and six months later ] [ Designated as safety issue: No ]

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


Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00905723

Contact: Teresa R Embiruçu, M.D. 5511-75413521
Contact: Regiane HB Rabelo, M.D. 5511-72307128

Ambulatório de Ginecologia Endócrina Recruiting
São Paulo, Brazil, 04039-060
Contact: Maria Cecília Santos, Nurse    5511-55496174   
Principal Investigator: Teresa R Embiruçu, M.D         
Sponsors and Collaborators
Federal University of São Paulo
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 Identifier: NCT00905723     History of Changes
Other Study ID Numbers: 0759/08 
Study First Received: May 19, 2009
Last Updated: May 19, 2009
Health Authority: Brazil: National Committee of Ethics in Research

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

Additional relevant MeSH terms:
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs processed this record on May 03, 2016