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NCT00905723 Clinical Trial

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

Postmenopausal Symptoms Clinical Trial

Official title:
Effects of Isoflavone and Estrogen in Sex Response in Climacteric Women

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT00905723
Other study ID # 0759/08
Secondary ID
Status Unknown status
Phase Phase 3
First received May 19, 2009
Last updated May 19, 2009
Start date May 2009

Study information
Verified date May 2009
Source Federal University of São Paulo
Contact Teresa R Embiruçu, M.D.
Phone 5511-75413521
Email embirucu2@yahoo.com.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Unknown status
Enrollment 60
Est. completion date
Est. primary completion date May 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• estradiol
1 mg daily for 6 months
• isoflavone
150 mg isoflavone daily for 6 months
• Placebo
sugar pill daily for six months

Locations
Country Name City State
Brazil Ambulatório de Ginecologia Endócrina São Paulo

Sponsors (1)
Lead Sponsor Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary McCoy's sexual questionnaire at recruitment and six months later
Secondary Kupperman's index at recruitment and six months later
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