NCT00076050

Brief Summary

The purpose of this study is to determine if soy-derived phytoestrogens (naturally occurring compounds similar to estrogen) can prevent bone loss and other menopausal symptoms in women who have recently gone through menopause. Study hypothesis: Tablets of high-dose, purified soy phytoestrogens spare the normally occurring spinal bone loss and improve biological and other emotional changes of menopause.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
248

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2004

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
7.5 years until next milestone

Results Posted

Study results publicly available

December 6, 2016

Completed
Last Updated

December 6, 2016

Status Verified

October 1, 2016

Enrollment Period

5.5 years

First QC Date

January 13, 2004

Results QC Date

June 26, 2013

Last Update Submit

October 12, 2016

Conditions

MenopauseOsteoporosisOsteopenia

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Bone Mineral Density

    baseline and 2 years

Secondary Outcomes (2)

  • Changes in Women's Health Questionnaire Score

    baseline and 2 years

  • Change in Vaginal Maturation Value

    baseline and 2 years

Study Arms (2)

1

EXPERIMENTAL

Participants will receive a 200-mg dose of soy isoflavones daily over 2 years.

Dietary Supplement: Soy isoflavones

2

PLACEBO COMPARATOR

Participants will receive placebo daily over 2 years.

Dietary Supplement: Placebo

Interventions

Soy isoflavonesDIETARY_SUPPLEMENT

Purified soy isoflavones (phytoestrogens) in tablet form tablets; 200 mg.

1
PlaceboDIETARY_SUPPLEMENT

Placebo soy isoflavones

2

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Absence of menstrual period for 12 months but not more than 5 years, or absence of menstrual period for 6 to 12 months and follicle stimulating factor (FSH) greater than 40 IU/L

You may not qualify if:

  • Treatment with estrogens, progesterone, raloxifene, or tamoxifen
  • Treatment with bisphosphonates, calcitonin, fluoride, or systemic corticosteroids
  • Use of soy/herbal supplements, including DHEA, within 3 months prior to study entry
  • Use of antibiotics in the month prior to study entry
  • Use of prescription medication to treat hot flashes
  • Chemical menopause, including post-chemotherapy
  • Hyperthyroidism
  • Hypothyroidism
  • Uncontrolled diabetes
  • Malabsorption syndromes or other chronic diseases
  • Body mass index (BMI) less than 20 or greater than 32
  • Bone mineral density (BMD) T-score below -2.0 in lumbar spine or femoral neck

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

Related Publications (1)

  • Levis S, Strickman-Stein N, Ganjei-Azar P, Xu P, Doerge DR, Krischer J. Soy isoflavones in the prevention of menopausal bone loss and menopausal symptoms: a randomized, double-blind trial. Arch Intern Med. 2011 Aug 8;171(15):1363-9. doi: 10.1001/archinternmed.2011.330.

    PMID: 21824950DERIVED

MeSH Terms

Conditions

OsteoporosisBone Diseases, Metabolic

Interventions

Soybean Proteins

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant ProteinsProteinsAmino Acids, Peptides, and ProteinsPlant Proteins, DietaryDietary ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaSoy FoodsVegetable ProductsVegetablesFood and Beverages

Results Point of Contact

Title
Silvina Levis MD
Organization
University of Miami
slevis@med.miami.edu
305-575-3388

Study Officials

  • Silvina Levis, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 13, 2004

First Posted

January 14, 2004

Study Start

September 1, 2003

Primary Completion

March 1, 2009

Study Completion

June 1, 2009

Last Updated

December 6, 2016

Results First Posted

December 6, 2016

Record last verified: 2016-10

Locations

US(1)