About the Study

How does KEEPS differ from the Women's Health Initiative studies?

Women in the WHI studies were 50-79 years old (average 62.7). The women participating in KEEPS will be 42-58 years old with their last menstrual cycle occurring within six months to three years. Thus, KEEPS women will be similar to the women in the many observational trials showing protection against heart disease by HT and less like those in the WHI study. The KEEPS investigators believe this is a critical difference because there are scientific reasons to believe that estrogen may only be effective in protecting against coronary artery disease if it is started early, before the disease gets a chance to develop.

What does KEEPS entail?

The study is a randomized, placebo-controlled double-blinded, prospective trial with two active treatment groups and one placebo group. It is a multi-center trial with eight centers around the country at which participants will be entered and followed, and a coordinating center, which oversees and administers the study. Participants will be treated for four years.

Women are randomly assigned to three treatment groups. The medications that are used in KEEPS are 0.45 mg of oral estrogen (Premarin® manufactured by Wyeth) and a transdermal (Climara®) skin patch manufactured by Berlex) as well as a progesterone (Prometrium®, manufactured by Solvay). The progesterone will be given to women on active estrogens only and given the first 12 days of the month.

Can I participate in KEEPS?

Summary of inclusion criteria:
  • 42-58 years of age

  • Menses absent for at least six months and no more than three years

  • Good general health

  • Have not used HT in the last three months or willing to undergo a “wash-out” period

  • Have not had a hysterectomy

When will the study begin and when will participants be recruited?

Recruiting for KEEPS has been completed.

Are there risks or side effects?

Prior to starting any clinical research study, an impartial, independent institutional review board (IRB) must decide that the potential benefits of the information to be obtained justifies the level of risk since there are no guarantees that the medication will be effective.

The principal investigator or study coordinator must explain any potential risks and benefits in detail to prospective participants before they consent to become part of the clinical study. Only the prospective participant can decide whether or not it is appropriate for her to participate.

What is informed consent?

Informed consent is required for participation in clinical studies involving human participants. Individuals are given information about what is involved in the study, including possible benefits and risks. The study coordinator encourages participants to ask questions. After informed consent is reviewed, individuals can make a decision whether or not to participate. The informed consent to participate is then documented in her medical history.

What safety procedures will you include?

Participants will be monitored at three-month intervals by questionnaires administered either during follow-up visits or by telephone contact.

Laboratory monitoring will be carried out at baseline, six months and yearly thereafter.

Participants also will undergo mammography at baseline (if no mammogram is available from the previous year) and then annually.

Are participants required to pay to be in a study?

There is no cost to the women who participate in KEEPS.

Will I be compensated for my participation?

Compensation is provided.

How is clinical research funded?

KEEPS is coordinated and funded by KLRI, a not-for-profit research institute, as part of its ongoing commitment to clinical research in aging and age-related diseases. KLRI has no affiliation with any pharmaceutical company.

Can a participant drop from a study at any time?

Just as a participant can decide not to become a participant in the study, she may choose to stop participation at any time.

 

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