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

NCT00905723 — Phase 3, Unknown, 60 participants, Federal University of São Paulo

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Effects of Isoflavone and Estrogen in Sex Response in Climacteric Women

Registry	NCT00905723
Status	Unknown
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	60 (Estimated)
Sponsor	Federal University of São Paulo (Other)
Conditions	Postmenopausal Symptoms
Interventions	estradiol, isoflavone, Placebo (Drug)
Dates	start 2009-05-01, primary completion 2010-05-01 (estimated), first posted 2009-05-20, last updated 2009-05-20
Locations	1 site in Brazil

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Estrogen	Experimental	Drug: estradiol	Women randomized to this group will receive daily pills containing 1 mg of estradiol
Isoflavone	Experimental	Drug: isoflavone	Women randomized to this group will receive daily pills of 150 mg isoflavone
Placebo	Placebo comparator	Drug: Placebo	Women randomized to this group will be administered daily placebo pills

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

+Outcome measures

Primary outcomes

McCoy's sexual questionnaire [at recruitment and six months later]

Secondary outcomes

Kupperman's index [at recruitment and six months later]

+Eligibility

Sex: Female, ages: 45 Years to 65 Years, accepts healthy volunteers

Inclusion Criteria:

* women aged 45-65 years old
* presenting climacteric symptoms
* sexual complaints

Exclusion Criteria:

* hormonal therapy
* counter indication to hormonal therapy
* uncontrolled comorbidities

+Locations (1)

Facility	City	Country	Status
Ambulatório de Ginecologia Endócrina	São Paulo, São Paulo	Brazil	Recruiting

+Investigators

Mauro A Aidar, M.D., PhD, Study chair, Universidade Federal de São Paulo

My Notes

Public

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