NCT00000612

Brief Summary

To conduct a three-armed trial assessing the effect of soy phytoestrogens on menopausal complaints, plasma lipids and lipoproteins, vaginal bleeding and endometrial proliferation, and health related quality of life.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 1996

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

January 1, 1996

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1998

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

May 13, 2016

Status Verified

November 1, 2000

First QC Date

October 27, 1999

Last Update Submit

May 12, 2016

Conditions

Cardiovascular DiseasesEndometrial HyperplasiaHeart DiseasesMenopausal ComplaintsUterine DiseasesMenopause

Interventions

estrogens, conjugatedDRUG
diet, soy proteinsBEHAVIORAL
dietary supplementsBEHAVIORAL

Eligibility Criteria

Age45 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Perimenopausal/menopausal women, ages 45 to 55.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • Clarkson TB, Anthony MS, Williams JK, Honore EK, Cline JM. The potential of soybean phytoestrogens for postmenopausal hormone replacement therapy. Proc Soc Exp Biol Med. 1998 Mar;217(3):365-8. doi: 10.3181/00379727-217-44246.

    PMID: 9492349BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesEndometrial HyperplasiaHeart DiseasesUterine Diseases

Interventions

Estrogens, Conjugated (USP)DietSoybean ProteinsDietary Supplements

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Estradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaPlant ProteinsProteinsAmino Acids, Peptides, and ProteinsPlant Proteins, DietaryDietary ProteinsFoodSoy FoodsVegetable ProductsVegetablesFood and Beverages

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

January 1, 1996

Study Completion

December 1, 1998

Last Updated

May 13, 2016

Record last verified: 2000-11