Trials / Unknown
UnknownNCT00905723
The Effects of Isoflavone and Estrogen in Sex Response in Climacteric Women
Effects of Isoflavone and Estrogen in Sex Response in Climacteric Women
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Federal University of São Paulo · Academic / Other
- Sex
- Female
- Age
- 45 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | estradiol | 1 mg daily for 6 months |
| DRUG | isoflavone | 150 mg isoflavone daily for 6 months |
| DRUG | Placebo | sugar pill daily for six months |
Timeline
- Start date
- 2009-05-01
- Primary completion
- 2010-05-01
- First posted
- 2009-05-20
- Last updated
- 2009-05-20
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT00905723. Inclusion in this directory is not an endorsement.