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Research Investigation of Soy and Estrogen

NCT00997893 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2020-12-07

Study results available
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Summary

The purpose of this study is to determine the effects of oral estradiol and soy phytoestrogens on anxiety, stress responsivity and cognition in perimenopausal women.

Conditions

Interventions

DIETARY_SUPPLEMENT

Soy Phytoestrogen

Novasoy® pill (55 mg)

DRUG

Estradiol

Estradiol pill (1 mg)

DRUG

Medroxyprogesterone Acetate (MPA)

medroxyprogesterone acetate (MPA) (10mg)

DRUG

Soy Placebo

oral placebo pill (0mg Soy Phytoestrogen)

DRUG

MPA Placebo

oral placebo pill (0mg MPA)

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Pauline M Maki, PhD · University of Illinois at Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2015-05-31
Completion
2015-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00997893 on ClinicalTrials.gov