Study Purpose

 

This study will help researchers determine if menopausal hormone therapy (HT) prevents or delays the onset of the number one killer of women, heart disease.

Questions KEEPS is Designed to Answer

Does initiating HT in recently menopausal women provide significant protection against hardening of the arteries (atherosclerosis), which is the major cause of heart attacks?

Is the alternative way of administering the natural estrogen, estradiol, using a skin patch, (a method known as transdermal) equally effective or potentially safer than oral estrogen?

 

 

Background

The KEEPS effort grew out of the perception that the (WHI) randomized, controlled trial of estrogen and progestin left questions unanswered regarding the hypothesis that estrogen prevents coronary vascular disease (CVD). The WHI investigators have interpreted the study as showing a lack of benefits or net negative risk/benefits ratio of HT.

High levels of protection against CVD have been observed in previous observational studies. An important difference between the WHI study and prior studies is the age at which women started HT. In the studies that showed protection against CVD, women began using HT for symptoms at the menopausal transition, whereas the WHI studied older women, most of whom had been postmenopausal for many years.

Physiological considerations and results of animal studies support the concept that estrogen may be beneficial for preventing early lesions of atherosclerosis, but ineffective, or even harmful, once the disease is established.

We are currently recruiting for KEEPS. Its major components include:

• Five-year, randomized, placebo-controlled, double-blinded study, each participant will be evaluated for four years.
  
• Conducted at 8 national sites
  
• Approximately 720 recently menopausal women ages 42 to 58 is being recruited
  
• Study participants will be divided into three groups and will receive either transdermal estrogen (via skin patch), oral estrogen or placebo

Women who are receiving active estrogen will also receive progesterone (the bio-identical human progestin) for 12 days per month.

 
 

Funding

KEEPS is funded by the Phoenix-based Aurora Foundation. KLRI is currently seeking additional funding sources to cover unfunded areas of KEEPS.

 

Coordinating Center: KEEPS will be coordinated through Phoenix-based Kronos Longevity Research Institute.