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

NCT00905723 | Unknown Phase 3

• 1 other identifier: 0759/08
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal Symptoms

Keywords

climacterium; sexual life; isoflavone; estrogen; McCoy's sexual questionnaire; Kupperman index

Outcome Measures

Primary Outcomes (1)

• McCoy's sexual questionnaire

  at recruitment and six months later

Secondary Outcomes (1)

• Kupperman's index

  at recruitment and six months later

Study Arms (3)

Estrogen

EXPERIMENTAL

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

Drug: estradiol

Isoflavone

EXPERIMENTAL

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

Drug: isoflavone

Placebo

PLACEBO COMPARATOR

Women randomized to this group will be administered daily placebo pills

Drug: Placebo

Interventions

estradiol DRUG

1 mg daily for 6 months

Estrogen

isoflavone DRUG

150 mg isoflavone daily for 6 months

Isoflavone

Placebo DRUG

sugar pill daily for six months

Placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• hormonal therapy
• counter indication to hormonal therapy
• uncontrolled comorbidities

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Ambulatório de Ginecologia Endócrina

São Paulo, São Paulo, 04039-060, Brazil

RECRUITING

Related Links

• Universidade Federal de São Paulo's web page

MeSH Terms

Interventions

Estradiol; Isoflavones

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Mauro A Aidar, M.D., PhD

  Universidade Federal de São Paulo

  STUDY CHAIR

Central Study Contacts

Teresa R Embiruçu, M.D.

CONTACT

5511-75413521; embirucu2@yahoo.com.br

Regiane HB Rabelo, M.D.

CONTACT

5511-72307128; gianehelena@ig.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 19, 2009
• First Posted: May 20, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2010
• Last Updated: May 20, 2009

Record last verified: 2009-05

Locations

BR (1)