Does Endometriosis Pain Impact You?

You are not alone.

You may qualify for the ELARIS EM-COC study if you:

  • Are a premenopausal woman between the ages of 18 and 49
  • Have had a surgical diagnosis of endometriosis
  • Have moderate-to-severe pain from endometriosis
  • Do not use nicotine (if 33 years or older)
  • Are not pregnant, actively trying to get pregnant or breastfeeding
  • Do not have osteoporosis (thinning, weak bones) or any other bone disease

Would you be interested in participating with the Clinical Research Center at the C.S. Mott Center for Human Growth and Development, Wayne State University?

Located right in Detroit, we invite you to find out if you may be able to take part in a study for women who experience moderate-to-severe pain associated with endometriosis. Eligible participants will receive all study-related care, investigational medication, and non-hormonal birth control supplies (as applicable) at no cost. In addition, eligible participants may receive compensation for time and travel. No health insurance is required.

Contact Us!

C.S. Mott Center for Human Growth and Development Wayne State University

313-577-4283

epaton@med.wayne.edu

About the ELARIS EM-COC Study

The ELARIS EM-COC study will enroll about 800 women with moderate-to-severe pain associated with endometriosis at approximately 160 research centers in the United States and Puerto Rico.

The study will include approximately 14 visits to our research center over approximately 21 to 45 months.

Volunteers who qualify to take part in the study may receive compensation for time and travel.

Participants will:

  • Receive all study-related care, the oral study medication, and non-hormonal birth control supplies at no cost.
  • Be monitored closely by an experienced study physician and medical staff.
  • Be able to discuss your endometriosis pain and learn more about the condition.
  • Help advance medical knowledge about using the study medication for endometriosis pain when taken with an oral contraceptive pill.

Watch the video to learn more

What is Endometriosis?

Endometriosis is an often-painful condition in which tissue that normally lines the uterus grows outside of the uterus. Typically, endometriosis will involve the ovaries, fallopian tubes, and the tissue of the pelvis, although in some rare cases, can spread beyond the pelvic organs to other areas of the body [1].

Endometriosis is estimated to affect 1 in every 10 women during their reproductive years [2]. This accounts for approximately 176 million women, worldwide.

Although women may experience endometriosis differently, common symptoms may be [1]:

  • Pain during menstruation (periods)
  • Painful bowel movements
  • Pain between periods
  • Depression and fatigue
  • Painful intercourse

Frequently Asked Questions about ELARIS EM-COC study

A clinical research study (also called a clinical trial) is a medical research study that 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 purpose of the ELARIS EM-COC study is to look at the safety and effectiveness of the oral investigational medication when taken together with a combined oral contraceptive that contains estrogen and progesterone, in women with moderate-to-severe pain due to endometriosis.

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

If you agree to be in this research study, the study doctor will determine if you are eligible. You may also be asked about your medical history, undergo medical tests (including physical examinations, blood, and urine tests, etc.), and complete questionnaires as part of your study participation. Please note you will also be asked to undergo dual energy X-ray absorptiometry (DXA) scans, as a means of measuring your bone mineral density throughout the study.

Eligible participants will be randomly assigned (like flipping a coin) to receive either the oral investigational medication or placebo in addition to a combined oral contraceptive or placebo once a day for 3 months. To prevent opinions about the investigational medication from affecting the study results, the study is designed so that participants, the study doctor, and the study staff will not know which study treatment arm you are assigned to. However, in the event of an emergency, this information can be provided. During this 3-month period, you will be able to take additional study-allowed pain medication prescribed by your study doctor if necessary, for your endometriosis pain. This is called “pain rescue medication”. After this initial 3-month period, all subjects will receive the active oral investigational medication (no placebo) plus the combined oral contraceptive. Both will be taken once a day.

The combined oral contraceptive contains both estrogen and progesterone medication, and has been approved by the US 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 to be used together with a combined oral contraceptive, therefore the use of the investigational medication combined with the oral contraceptive is investigational (experimental) for the purposes of this study.

In total, your participation in this study will last approximately 21 to 45 months and include approximately 14 study visits to the research center and approximately 10 phone visits.

Volunteers who qualify to take part in the study may receive compensation for time and travel. Please discuss this with us when we 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 that are done only for the study. You or your insurance company will be responsible for the costs of your regular medical care. Regular medical care costs are the costs for medications, treatments, procedures, and testing that you would have had if you were not in the study.

Our Clinical Research Center at team at WSU will be able to explain more about what the ELARIS EM-COC 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.