Do You Have
Pain Caused by Endometriosis?

A clinical research trial (also called a clinical trial) is a medical research study that assists in answering essential questions about an investigational medication. One critical aspect includes determining how well an investigational drug works for a specific condition. Testing is done on all medications in clinical research studies before they are approved and prescribed to patients.

The ELARIS EM-COC study aims to assess the safety and effectiveness of the oral investigational medication when taken with a combined oral contraceptive containing estrogen and progesterone. The study specifically focuses on women with moderate-to-severe pain due to endometriosis.

This study is being conducted at 160 research centers in the United States and Puerto Rico. Approximately 800 volunteers with moderate-to-severe endometriosis-associated pain will participate in this study.

The study doctor will determine your eligibility if you agree to be in this research study. You may also be asked about your medical history, undergo medical tests (such as physical examinations, blood work, urine analysis, etc.), and complete questionnaires as part of your study participation. Please note that you will also be asked to complete X-ray absorptiometry (DXA) scans that measure your bone mineral density throughout the study.

Eligible participants will be assigned randomly to receive either the oral investigational medication or placebo in addition to a combined oral contraceptive or placebo once a day for three months. To prevent any biases from affecting the results, participants, the study doctor, and the study staff won’t know which study treatment selection you’ve received. However, this information will be available in the event of an emergency. During these three months, you can take additional study-allowed pain medication prescribed by your study doctor, if necessary, for your endometriosis pain (known as “pain rescue medication). After this initial three-month period, all subjects will receive the active oral investigational drug (no placebo) plus the combined oral contraceptive, both taken once a day.

The combined oral contraceptive contains both estrogen and progesterone medication. It has been approved by the U.S. Food and Drug Administration (FDA) as a method of contraception. The investigational medication has been FDA-approved for moderate-to-severe pain associated with endometriosis. However, the investigational medication is not approved for use with a combined oral contraceptive. Therefore, this study will determine whether using the investigational drug and the oral contraceptive together is safe and effective.

Participation in this study will last approximately 21 to 45 months, with 14 study visits to the research center and ten phone visits.

Volunteers who qualify to participate in the study may receive compensation for time and travel. Please discuss this with the study team when they contact you.

There is no cost to participate in the ELARIS EM-COC study.

If you decide to take part, you will be monitored closely by an experienced study doctor and medical staff. You will receive all study-related care, investigational medication, and non-hormonal birth control supplies at no cost.

Neither you nor your insurance company will have to pay for the investigational medication (or placebo) or procedures required solely for the study. You or your insurance company will be responsible for your routine medical care costs. Routine medical care costs are medications, treatments, procedures, and testing that you would have had if you were not in the study.

The research center team will explain in detail what the ELARIS EM-COC study will involve, and it is up to you to decide if you wish to participate. Participation in this study is voluntary. Your decision will not affect your current or future relationships with your doctor. You are free to withdraw at any time should you choose to volunteer.

We try to match you to a research center within a close travel distance from your home. If we are not conducting the study in your area currently, with your permission, we will keep you in our database and reach out once a research center in your location becomes available.

If you decide you no longer want your information stored at any time, please let us know, and we will delete your data (called opt-out).

We will match you to a clinical research center located in your area that needs volunteers for the study or notify you when one nearby becomes available. A study staff member from the research center will contact you and discuss your participation if you qualify.

If you think you might like to participate in the ELARIS EM-COC study or would like more information, please enter your information below so we can see if you qualify and contact you about the study. Keep in mind that participation is entirely voluntary. If you decide to partake in the study, you may change your mind about participating at any time.