CLINICAL CENTERS AND COORDINATING CENTER FOR A SAFETY FOLLOW-UP STUDYTO THE POSTMENOPAUSAL ESTROGEN/PROGESTIN INTERVENTIONS TRIAL



NIH GUIDE, Volume 22, Number 33, September 17, 1993



RFP AVAILABLE:  NHLBI-HR-94-02

                NHLBI-HR-94-03



P.T. 34



Keywords:

  Clinical Trial 

  Hormones 



National Heart, Lung, and Blood Institute



The National Heart, Lung, and Blood Institute (NHLBI) intends to

negotiate with:  (1) George Washington University, (2) Johns Hopkins

University, (3) Stanford University, (4) University of California,

Los Angeles, (5) University of California, San Diego, (6) University

of Iowa, (7) University of Texas, San Antonio, and (8) Bowman Gray

School of Medicine for conduct of safety follow-up of women recruited

into the Postmenopausal Estrogen/Progestin Interventions (PEPI)

Trial.  The active phase of the three-year PEPI Trial required these

institutions to collect data to evaluate the effects of five study

treatment regimens on cardiovascular disease risk factors.  The

duration of the PEPI Trial represents the longest duration to date of

a clinical trial assessing the effects of hormone replacement

therapies.  However, the long-term risks and benefits of hormonal

therapies in postmenopausal women remains controversial.  The

proposed three and one-half year study provides for minimal safety

follow-up of the existing PEPI cohort.  The primary focus of the

safety follow-up will be three annual endometrial biopsies and

mammograms, in the cohort of 875 women, beginning in February 1994.

Six months will be allowed for analysis of the data collected during

the three-year safety follow-up.  Inherent duplication of cost to the

Government and unacceptable delays in completing the project make

competition unfeasible for this phase of the study, which provides

for safety follow-up of the subjects and analysis of collected data.



.

Return to 1993 Index

Return to NIH Guide Main Index

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.