A research study (also called a clinical trial) helps to answer important questions about an investigational medication - these may include how well an investigational medication works for a certain condition. All medications must be tested in clinical research studies before they can be approved and prescribed to patients.

The Luminous Research Study is for an investigational birth control patch for women who wish to use a skin patch to prevent pregnancy. Healthy female participants of childbearing potential aged at least 16 years old who agree to be in this study will receive transdermal patches containing norelgestromin and ethinyl estradiol.

The study will enroll approximately 1,200 subjects (1,080 women aged 16 to 35 years and about 120 women over 35 years of age) at about 55 study centers across the United States.

The first stage of the study will consist of a screening period, where you will be asked to visit our study center and the study doctor will find out if you are eligible to enter the study.

If you are eligible for the study, you will be asked to return to our study center. You will have various tests done and will then start taking study medication. If the study doctor decides that you are not eligible to take part in this study, then he/she will discuss other contraceptive options with you.

Before you enter the study, there will be a screening period after which the study doctor will determine if you qualify for the study. During this screening period, you will complete:

• 1 clinic visit that can be spread out over multiple visits

• one week of daily entry into and electronic handheld diary (also called an eDiary)

The eDiary can be installed on your device (cell phone) or a device will be provided. Our study team will train you on how to use the eDiary.

If you are eligible to participate, the study medication patches will be provided to you at the enrollment visit (within 14 days before the start of your next menstrual cycle).

You will be instructed to apply the first transdermal patch within 24 hours of the start of the next menstrual period. Before you use the investigational birth control patch, you will be taught how to apply the patch using a patch that does not contain any active ingredients.

Throughout the study, you will complete:

• 6 clinic visits

• 9 scheduled phone calls

• daily eDiary entries

Qualified participants may receive compensation for time and travel.

Please discuss potential travel expenses and compensation with our study team.

There is no cost to participate in the Luminous Research Study. If you decide to take part:

• you will not incur any costs for participating in this study

• all study-related care will be provided by study doctors and study staff

Our research team will be able to explain more about what the Luminous Research Study will involve, and it is up to you to decide if you want to take part. Participation in this study is voluntary. Whether or not you decide to participate in this study will not affect your current or future relationships with your doctors. If you decide to participate, you are free to withdraw at any time without affecting those relationships.

Our site is located at 1617 South Tuttle Avenue, #1A in Sarasota, Florida 34239. We are on the ground floor.

A research study is the process by which new and innovative medications, interventions and treatments are approved and brought to market, so people can live happier and healthier lives. Even over-the-counter medications such as NSAIDs, you may have used to counteract a headache, have gone through the clinical research study process before they were available to your local pharmacy.