NCT00179556

Brief Summary

Hot flashes occur in three quarters of menopausal women, and can negatively impact quality of life. Interest has arisen in isoflavones, found in rich supply in soy products, as therapy for hot flashes. The study examines the effect of a new soy supplement, as compared to a placebo, in menopausal women on hot flash symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

March 14, 2017

Status Verified

March 1, 2017

Enrollment Period

2.1 years

First QC Date

September 13, 2005

Last Update Submit

March 12, 2017

Conditions

Menopausal Symptoms

Keywords

Hot flashesMenopausal symptomsSoybean germAglyconesMenopause

Outcome Measures

Primary Outcomes (1)

  • Hot flash frequency and severity

Secondary Outcomes (1)

  • Menopausal quality of life

Interventions

Isoflavone supplementDRUG

Eligibility Criteria

Age38 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No menstrual period for at least six months, Hot flashes at least four t imes per day, Ages 38-65

You may not qualify if:

  • Pregnant, BMI\>45, History of breast cancer or other estrogen dependent tumors, Abnormal uterine bleeding, Heart, renal, or liver disease, Diabetes, Women taking hormone replacement therapy or serotonin reuptake inhibitors, Women taking any dietary supplements for the treatment of hot flashes (ex. soy supplements, vitamin E, flaxseed, red clover extract) within the past 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hope Ricciotti, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

  • George Blackburn, MD, PhD

    Beth Israel Deaconess Medical Center

    STUDY CHAIR

  • Lalita Khaodhiar, MD

    Beth Israel Deaconess Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Obstetrics, Gynecology and Reproductive Biology

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

June 1, 2003

Primary Completion

July 1, 2005

Study Completion

September 1, 2005

Last Updated

March 14, 2017

Record last verified: 2017-03

Locations

US(1)