FH 3162-0008

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

• I am a healthy female, meaning no significant medical conditions
• I am between 18 and 45 years old
• My BMI is  between 18.0 and 29.9 kg/m2
• I have regular menstrual cycles
• I am not currently participating in an investigational study and have not taken an investigational medication within 1 month prior to enrollment
• I have a low risk of getting pregnant and currently using one of the following forms of contraception – sterilized, in exclusively same-sex partnership, abstinent, in monogamous relationship with vasectomized partner, using non-hormonal IUD or consistently using barrier methods of contraception
• I am willing to have a PAP smear or mammogram if needed
• I have not been pregnant in the last 3 months and do not intend to become pregnant in the next 24 months
• I have not used an injectable contraceptive in the last 12 months
• I am able to communicate effectively in English with the study personnel

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.  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.  

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 determine if you fully qualify, it will be necessary to obtain blood and urine  samples after an 8-hour fast.  You have the option of fasting for a blood or urine sample at the screening appointment, or, you may return at a later date for us to obtain these samples. 

If you fast, you should refrain from eating or drinking anything (with the exception of water) for 8 hours before your appointment. 

Be sure to bring all of your medications with you to your screening appointment. 

Please note, you need to bring a valid, non-expired photo ID with you when you attend your screening visit.  We accept a government issued identification card such as a driver's license, state issued ID card, military ID or passport.  You will be required to show this same photo ID at all study visits.

You will be filling out paperwork for the study.  Please arrive at least 30 minutes in advance of your screening appointment.  If you are late for your appointment you may not be seen or may need to reschedule. 

Be advised that you may need to provide medical records as part of the screening process for this study.  If possible, please bring your full medical records with you to your screening appointment.  If you cannot bring your records with you, you must provide them before you can admit to the study.  Note that full medical records include surgical reports.  You will not be allowed to participate in the study without medical records defined as:

• All medical records, including but not limited to: office notes, face sheets, history and physical, consultation notes, inpatient, outpatient and emergency room treatment, all clinical charts, reports, surgical reports, order sheets, progress notes, nurse's notes, social worker records, clinic records, treatment plans, admission records, discharge summaries, reports of consultations, documents, correspondence, test results, statements, questionnaires/histories, from your medical provider(s).
• For females, surgical reports are required as documentation for procedures such as hysterectomy, bilateral oophorectomy and tubal ligation. 

Notice:

In order to schedule a screening appointment online, you will be required to enter your personal information (name, date of birth, 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 Early Phase Services.  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 any time by logging in to the scheduling program and choosing “My Profile” and then selecting the “Terminate Account” button.  

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