ICON Early Phase Services is conducting a research study for healthy females ages 18-45.
Clinical trial study for healthy females ages 18-45
The purpose of this study is to evaluate the effect and safety of a single dose of an investigational birth control drug compared to an existing birth control drug (given as an injection under the skin).
Vital signs, physical examinations to include a pap smear(if needed)and pregnancy testing will be performed. Blood and urine samples will also be obtained during this study. A Mammogram will be scheduled if needed.
Participants will complete:
1 screening visit
34 outpatient visits
Length of study from dosing to end of study is approximately 52 weeks
To determine if you fully qualify, it will be necessary to obtain blood samples after an 8- hour fast. You have the option of fasting for the screening appointment, or, you may return at a later date. If ICON does not have your medical records on file, you will need to provide medical records at screening.
For more information, see below.
I am a healthy female, meaning no significant medical conditions
My BMI is between 18.0 and 35.0 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.
Name of Clinical Site
8307 Gault Lane, San Antonio, TX, USA