The purpose of the study is to determine what effect the investigational drug has on the liver and menstrual cycle of healthy women. The study drug is being developed for the treatment of uterine fibroids and endometriosis and will be given orally as a capsule.

 

Vital signs, ECGs, physical and pelvic examinations, pap smears, vaginal ultrasounds, blood and urine samples will be obtained or performed during this study.

 

Qualified Participants will complete:

 

·          1 screening visit

·          2 overnight stays (non-consecutive)

·          13 outpatient visits

·          1 follow up visit

 

You may be compensated up to $2700.00 for time and travel if all procedures are completed.

 

If you are able to answer “YES” to the following statements, you may qualify for this study.

 

I am a healthy female between the ages of 18 to 50.

 

My BMI is between 18 and 39 kg/m^2.

I am not pregnant or lactating.

 

I have a normal menstrual cycle of 26 – 32 days.

 

Included in this group are women with the following conditions (not currently under treatment):

 I am willing to not attempt to become pregnant.

 

I am willing to discontinue hormonal contraceptives and am willing to use double barrier contraceptives over the course of the study.

 

I have not used oral contraceptives or hormone releasing IUDs in the last 30 days or Depo-Provera® in the past 6 months.

 

I have not received an investigational drug within the last 30 days prior to the study.

 

I am willing to limit alcohol consumption to no more than 2 drinks per week and avoid alcohol consumption within 48 hours of each visit.

 

I do not have a history of any of the following:

 I do not currently or plan to take for at least 2 weeks prior to screening and during the study any of the following:

 

It is important to understand that even if you feel that you meet all the above criteria, you are still required to complete the protocol screening procedures. Frequently, subjects do not qualify because of medical history, or minor changes in vital signs, ECG and lab tests.   Scheduling a screening appointment does not guarantee that you will qualify for that study. Additionally, subjects are screened on a first come first served basis, and studies may complete enrollment prior to your visit. Additionally, no guarantees can be made regarding group assignments for any particular study. ICON will not assume any liability for lost time, travel or failure to qualify.

 

To fully qualify, it will be necessary to obtain blood samples after a 8 hour fast. You have the option of coming to the screening appointment fasting or you may return at a later date to obtain fasting blood work. If you choose to come fasting, you will need to refrain from eating or drinking anything (with the exception of water) 8 hours before your appointment.

 

We will be testing for alcohol and illegal drugs. You have the option of obtaining a urine sample at the screening appointment or you may return at a later date to obtain urine for a drug sample.

 

If you are able to answer “YES” to the above questions and would like to make an appointment online please click on the following link:

 

 (We will need to know the 1st day and last day of your last two menstrual cycles.)

 

Study Dates   -    Note: Your actual dates will depend on your individual menstrual cycle.

 

  Visit 1A: 17Aug10

 Visit 1B: 24Aug10

 Visit 1C: 31Aug10

 Visit 6 Week 4: 12Oct10

 Visit 7 Week 5: 19Oct10

 Visit 8 Week 6: 26Oct10

 Visit 9 Week 7: 02Nov10

 Visit 10 Week 8: 09Nov10

 Visit 11 Week 9: 16Nov10

    Visit 12 Admit: 22Nov10

 Visit 13 Follow Up: 28Dec10

 

 

Notice:

 

In order to schedule a screening appointment online, you will be required to enter your personal information (name, DOB, etc.) into a secure, password protected database. Your information will remain confidential and will not be accessible by any party that does not work directly for ICON Clinical Research. It may be necessary for the recruitment staff to contact you by phone in the event of a schedule change or if more information is needed. You have the right to remove your information from the database at anytime by logging in to the scheduling program and choosing “My Profile” and then selecting the “Terminate Account” button.