Effects of the Concentrated Extract of Soy on Coagulation Factors After Menopause

Menopause Clinical Trial

Official title:

Effects of the Concentrated Extract of Soy on Coagulation Factors After Menopause

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00925639
• Other study ID #: CEP/UNIFESP 0728/08
• Status: Not yet recruiting
• Phase: Phase 3
• First received: June 19, 2009
• Last updated: June 19, 2009
• Start date: August 2009
• Est. completion date: August 2010

Study information

• Verified date: June 2009
• Source: Federal University of São Paulo
• Contact: Regiane HB Rabelo, MD
• Phone: 5511-72307128
• Email: gianehelena[@]ig.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Hypoestrogenism, common in menopause, is responsible for systemic and metabolic changes affecting women's wellness, favoring hot flashes, urogenital atrophy and bone mass loss. Hormone reposition therapy (HRT) with estrogen or estrogen associated to progesterone is administered to minimize these effects. Meanwhile, the beneficial effects of HRT are known, there is still concern about its adverse effects such as thromboembolic and cardiovascular effects, increased risk of breast and endometrial cancer. Thus, there is an increasing interest in the development of phytohormonal HRT. The aim of the investigators' study is to evaluate the effects of concentrated extract of soy on hypercoagulation markers in menopausal women.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: August 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• > 1 year of amenorrhea

• 45 to 65 years old

• without hormone reposition treatment or herbal medications in the 6 months preceding the research

Exclusion Criteria:

• history of thromboembolism

• history of cardiovascular disease

• presence of estrogen dependent neoplasia

• presence of abnormal genital bleeding

• uncontrolled metabolic diseases

• smoking or drinking habits

• use of anticoagulants or acetyl salicylic acid

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menopause

Intervention

Drug:
• Isoflavone
150 mg of concentrated extract of soy containing 60 mg of isoflavone comprising 40 mg of genistein, 14,55 mg of daidizein, 3,02 mg of daidzine, 1,14 mg of glicitine, 0,91 mg genistine and 0,38 mg of glicetein.
• Placebo
Starch pill

Locations

Country	Name	City	State
Brazil	Ambulatório de Ginecologia Endócrina	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of serum DDimer		3 months	Yes

External Links

•   Universidade Federal de Sao Paulo's web page