NCT00012909

Brief Summary

The decision regarding the use of post-menopausal estrogen hormone replacement therapy (HT) is complex because patients must balance the short and long-term risks and benefits. Information from new and important clinical trials must also be considered. The purpose of this research is to develop and evaluate the efficacy of a HT CD-ROM decision-aid in improving the decision making process for women considering the use of estrogen HT.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

March 14, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2001

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
Last Updated

April 7, 2015

Status Verified

November 1, 2007

First QC Date

March 14, 2001

Last Update Submit

April 6, 2015

Conditions

MenopauseHormone Replacement Therapy

Study Arms (1)

Arm 1

OTHER
Behavioral: Hormone Replacement Therapy Decision-Aid

Interventions

Hormone Replacement Therapy Decision-AidBEHAVIORAL
Arm 1

Eligibility Criteria

Age45 Years - 74 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- postmenopausal as defined by: Amenorrhea for 12 months or FSH greater than or equal to 25

You may not qualify if:

  • unable to speak English
  • are assessed not to have capacity for making medical decisions for their own care
  • had alcohol or drug abuse issues in past 6 months before baseline visit
  • personal history of breast cancer, active liver disease, active vascular thrombosis, and/or active unexplained vaginal bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-5000, United States

Location

Clement J. Zablocki VA Medical Center, Milwaukee, WI

Milwaukee, Pennsylvania, 53295-1000, United States

Location

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

  • Schapira MM, Gilligan MA, McAuliffe TL, Nattinger AB. Menopausal hormone therapy decisions: insights from a multi-attribute model. Patient Educ Couns. 2004 Jan;52(1):89-95. doi: 10.1016/s0738-3991(02)00266-5.

    PMID: 14729295RESULT

Study Officials

  • Marilyn M. Schapira, MD MPH

    Clement J. Zablocki VA Medical Center, Milwaukee, WI

    PRINCIPAL INVESTIGATOR

  • Arneda Van White, MD

    Edward Hines Jr. VA Hospital, Hines, IL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2001

First Posted

March 16, 2001

Study Completion

March 1, 2004

Last Updated

April 7, 2015

Record last verified: 2007-11

Locations

US(3)