Coping with endometriosis pain can be difficult and exhausting, especially if you’ve had it for several years. You may have tried pain medications, birth control pills and/or surgery, but continue to experience pain. Watch the video and learn why this research study may be an option to consider.
A common symptom of endometriosis is pain during and between periods.1
Other symptoms include1:
These symptoms may make daily activities difficult to perform, and even interrupt time with friends and family.
Endometriosis pain affects over 170 million women worldwide.2
This clinical research study is evaluating an oral investigational medication to see if it may reduce moderate to severe pain associated with endometriosis.
This research study will be conducted at a hospital, research center, or a designated doctor's office. After you pre-qualify, the study staff will discuss additional details such as study duration, location, and number of visits involved, and help answer any questions you may have. As a study participant, your endometriosis will also be closely monitored by the study staff (nurses and clinicians) under the guidance of the study doctor. You will also receive the investigational medication and study-related tests and procedures at no cost.
The investigational medication is taken by mouth and reduces the amount of estrogen produced in your body without completely blocking it. During the first half of the study period, there is a chance you may receive a placebo. A placebo resembles the investigational medication, but contains no active medication. However, there is no placebo in the second half of this research study and all participants will receive the investigational medication.
Deciding to participate in a clinical research study is a complex and personal decision. If you are unsure and want to learn more about the value of participating in clinical research studies, you can download this brochure (PDF), and discuss the study information with your primary doctor and/or family members.
Study participation may also help advance medical knowledge of endometriosis. Consider the possibility of participating in this research study.
I’ve tried many options for my endometriosis pain. I am looking into a research study.
Endometriosis occurs when the tissue that normally lines the uterus (also called endometrium) grows outside your uterus—on your ovaries, fallopian tubes, outer wall of the uterus, the intestines, or other organs in the abdominal area. The most common symptom of endometriosis is pain during or between your periods.1
Each month during your menstrual cycle, endometrial tissue grows and thickens due to estrogen hormones produced by your ovaries. The normal endometrial tissue inside your uterus flows out during your period. The “displaced” endometrial-like tissue outside your uterus continues to act as endometrial tissue normally would. This can result in irritation, inflammation, and pain.
The Equinox Study is evaluating an oral investigational medication to see if it may reduce moderate to severe pain associated with endometriosis.
The investigational medication being tested in this clinical research study has been previously evaluated for endometriosis-associated pain through several other research studies, which are now complete.
This research study will be conducted at about 200 research sites in the US, Canada, and Puerto Rico, and will enroll approximately 700 participants after they qualify. The research study is part of the Elaris Program, which is studying the safety and effectiveness of the oral investigational medication for various health conditions.
This clinical research study will last for approximately 27 to 50 months, and requires up to 16 to 19 office visits with 11 additional phone visits. If you pre-qualify and are referred to the research site, the study staff can provide you with more information.
After you pre-qualify, the study team will go over additional details related to your participation. As part of this process, you will be asked to review the Informed Consent Form (ICF), which explains the purpose of this research study, procedures, benefits, risks, and precautions. Also, there are other requirements, which will be discussed with you to determine if you are eligible to participate. If you meet the eligibility criteria and decide to participate, you will be asked to sign the ICF and will be enrolled this clinical research study.
Once enrolled, you will be scheduled for periodic study visits related to study exams, procedures, questionnaires and to evaluate your general health. You will also be asked to keep a daily electronic diary. Throughout the study period, you are encouraged to discuss your health or study-related medical care with the study doctor or staff. It is also important that you take all prescribed medication and attend all scheduled visits.
AbbVie is the sponsor of this clinical research study. To learn more about the sponsor, visit abbvie.com.
‘Investigational medication’ means that the medication is being tested through a clinical research study, and has not yet been approved by the FDA to be prescribed by doctors.
In previously conducted clinical research studies, over 3,700 women have taken the same oral investigational study medication that is being evaluated in the Equinox Study.
A placebo resembles the investigational medication, but contains no active medication. A placebo is used in clinical research studies to determine if the active medication being evaluated is safer and more effective than no treatment at all. During the first half of the study period, there is a chance you may receive a placebo. However, there is no placebo in the second half of this research study and all participants will receive the investigational medication.
If you are currently taking medication or scheduled to take medication in the future, you should let the study team know before you enroll in the study. The study team will go over this with you in detail and will let you know if you need to stop taking any of your current medications. Please do not stop taking your current medication without discussing it with the study staff.
There is no charge for taking part in this research study. All study-related exams, visits to the study center, procedures, and medications related to the research study will be covered.
Your participation in this clinical research study is entirely voluntary and you may withdraw from participating, without penalty or effect on your future medical care. If you decide to withdraw early from this research study, you will be asked to notify the research staff before doing so. You will be asked to return to the research site at least once to complete a final visit and return any unused study medications and other supplies.
If you pre-qualify and are referred to a nearby research site, the study staff can discuss compensation that may be available.
You do not need your primary doctor’s permission to participate. If you choose to inform him/her about your participation and progress, the study team can do so on your behalf after receiving consent. You can also discuss this clinical research study with your primary doctor prior to participation.
A clinical research study, also known as a clinical trial, is conducted to evaluate the safety and effectiveness of an investigational medication compared to standard care or placebo. If the medication is proven to be safe and effective during a clinical research program, the US Food and Drug Administration (FDA) may approve it for prescription use. In addition to studying the effectiveness and safety of medications, a research study may also help advance knowledge about specific health-related issues, such as endometriosis pain.
It takes a team of healthcare professionals to conduct a research study. Besides the primary doctor who oversees this research study, the research team may include other doctors, physician assistants, nurses, medical assistants and other healthcare professionals. It is only through the completion of research studies that investigational medications can be evaluated and, if proven safe and effective, may be approved for use by the FDA. All prescription medications in use today were first proven safe and effective in clinical research studies. For more information about clinical research studies in general, visit https://clinicaltrials.gov/ct2/about-studies.
To help ensure that a clinical research study is ethical and that participants’ rights are protected, Institutional Review Boards (IRB) or Ethics Committees (EC) review and approve study protocols.
Only volunteers who meet all of the eligibility criteria for a clinical research study may take part. The study team at the research site you select will review your medical history and current medical status against the eligibility criteria. They will determine if you may qualify to participate in this research study. You may also be asked to provide information from your medical records and undergo certain tests or procedures to help the study team determine if you qualify.
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