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

Federal University of São Paulo

Status and phase: Unknown; Phase 3

Conditions: Postmenopausal Symptoms

Treatments: Drug: estradiol; Drug: Placebo; Drug: isoflavone

Study type: Interventional

Funder types: Other

Identifiers

NCT00905723

0759/08

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

Estrogen

Experimental group

Description:

Women randomized to this group will receive daily pills containing 1 mg of estradiol

Treatment:

Drug: estradiol

Isoflavone

Experimental group

Description:

Women randomized to this group will receive daily pills of 150 mg isoflavone

Treatment:

Drug: isoflavone

Placebo

Placebo Comparator group

Description:

Women randomized to this group will be administered daily placebo pills

Treatment:

Drug: Placebo