Visit 1

Your first visit to the University of Illinois at Chicago is a screening visit to ensure that you qualify for the study. You will first meet with the research coordinator to go though the informed consent process where the study will be explained to you in detail and our privacy policy will be explained. At this point, you can choose if you would like to continue with your participation in the study.

Following the informed consent process, you will meet with our study physician where your medical history will be reviewed and she will give you a brief physical. There will be a small blood draw in order to measure your cholesterol and hormone levels. After the physical, you will meet with a psychologist for about two hours to review your psychological history.

If the results from the physical and psychological interview show that you qualify, you will meet with our research coordinator. At this time, you will complete a few, short tests of cognitive abilities and a short questionnaire. As well, the research coordinator will provide you with and explain to you the daily diaries that are to completed everyday throughout the course of the study.

Visit 2

At this visit, you will meet one-on-one with a study coordinator. She will instruct you on how to go through paper and pencil, verbal and computerized tests of mental abilities, including memory, attention and language.

Visit 3

Visit 3 is to take place the day after visit two. It is comprised of a series of questionnaires, completing a memory task and undergoing a language evaluation. At various time points during the visit, you will be asked to provide saliva samples. Also, throughout the visit you will wear a small heart rate monitor. At the end of the visit, you will be provided with your study treatment which is to be taken twice a day for the next twelve weeks. You will also be provided with your post-treatment pills. This is not to be taken until you have completed your twelve weeks of treatment.

Visit 4

This visit is to take place ten weeks after you have started your treatment and serves as a safety check. We will meet with you to discuss any potential changes in your health and how your progress with the study is going. At this time, there will be a second small blood draw.

Visit 5

At this visit, you will meet one-on-one with the study coordinator. This visit is going to follow the same procedures as described in visit 2. You will complete different tests on mental abilities.

Visit 6

Visit 6 will be conducted the following day after visit 5 and will be similar to visit 3. You will complete a series of questionnaires, complete a memory task, go through a language evaluation, provide saliva samples and wear a heart rate monitor throughout the session.

Visit 7

At this visit, you will meet with the study physician for the exit physical

Hot Flash Monitoring

At your first and fourth visit, will hook you the hot flash monitor which you will wear over the course of a 72 hour period. The times and locations for the monitor to be attached as well as returned will be discussed. The monitors will be returned using an oversight shipment box that you will be provided with.

Actigraph Watch

You will be wearing the actigraph watch along with the hot flash monitor. The days which you wear this device will be determined by you and the research coordinator around your first and fourth visits. The watch measures how much you are moving across the day and provides us with an objective measure of sleep. The watch should be worn on the non-dominant hand, and is small and light.

Phone Safety Screens

At weeks 2, 4, 6 and 8 following your start of taking the study treatment, you will be receiving a phone call from a member of the lab. They will be asking you about any adverse events you may be experiencing, if you have taken any other medications during the course of your treatment, and will see if you have any questions about completing the daily diaries. As well, they will ask you to count the number of pills you have left.

Study Design