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

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ClinicalTrials.gov Identifier: NCT00905723
Recruitment Status : Unknown
Verified May 2009 by Federal University of São Paulo.
Recruitment status was:  Recruiting
First Posted : May 20, 2009
Last Update Posted : May 20, 2009
Sponsor:
Information provided by:
Federal University of São Paulo

Brief Summary:
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 or disease Intervention/treatment Phase
Postmenopausal Symptoms Drug: estradiol Drug: isoflavone Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : May 2009
Estimated Primary Completion Date : May 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Estrogens

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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older 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

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

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 Posted: May 20, 2009    Key Record Dates
Last Update Posted: May 20, 2009
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