The Effects of Isoflavone and Estrogen in Sex Response in Climacteric Women
- Registration Number
- NCT00905723
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 60
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Isoflavone isoflavone Women randomized to this group will receive daily pills of 150 mg isoflavone Placebo Placebo Women randomized to this group will be administered daily placebo pills Estrogen estradiol Women randomized to this group will receive daily pills containing 1 mg of estradiol
- Primary Outcome Measures
Name Time Method McCoy's sexual questionnaire at recruitment and six months later
- Secondary Outcome Measures
Name Time Method Kupperman's index at recruitment and six months later
Trial Locations
- Locations (1)
Ambulatório de Ginecologia Endócrina
🇧🇷São Paulo, Brazil