Postmenopausal Symptoms
Conditions
Keywords
climacterium, sexual life, isoflavone, estrogen, McCoy's sexual questionnaire, Kupperman index
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.
Interventions
DRUGestradiol
1 mg daily for 6 months
DRUGisoflavone
150 mg isoflavone daily for 6 months
DRUGPlacebo
sugar pill daily for six months
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| McCoy's sexual questionnaire | at recruitment and six months later |
Secondary
| Measure | Time frame |
|---|---|
| Kupperman's index | at recruitment and six months later |
Countries
Brazil
Contacts
Primary ContactTeresa R Embiruçu, M.D.
Backup ContactRegiane HB Rabelo, M.D.
Outcome results
None listed