A Phase 3 interventional study of estradiol and isoflavone in Postmenopausal Symptoms, sponsored by Federal University of São Paulo. Status unknown at 1 site in Brazil. Open to female participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-05-20.
Sponsored by Federal University of São Paulo · Phase 3, Interventional, and Treatment
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.
Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Women randomized to this group will receive daily pills containing 1 mg of estradiol
Drug: estradiol
Women randomized to this group will receive daily pills of 150 mg isoflavone
Drug: isoflavone
Women randomized to this group will be administered daily placebo pills
Drug: Placebo
1 mg daily for 6 months
150 mg isoflavone daily for 6 months
sugar pill daily for six months
McCoy's sexual questionnaire
Time frame: at recruitment and six months later
Kupperman's index
Time frame: at recruitment and six months later
This study is status unknown, as verified in May 2009. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Federal University of São Paulo