Endometriosis is a condition in which tissue that normally lines the uterus grows outside of the uterus. This tissue, which does not belong outside the uterus, becomes trapped and can cycle with your period, bleed, and cause symptoms like pain. It can also cause irritation that can lead to scarring and “adhesions,” which are abnormal bands of tissue that can cause organs to stick to each other. Endometriosis can lead to trouble getting pregnant.
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The SPIRIT clinical research program consists of two clinical trials testing whether an investigational medicine, relugolix, used in combination with female hormones, is safe and reduces the pain associated with endometriosis. It also looks at how the pain affects how you function and feel. Patients who complete either of these two clinical trials may qualify for another trial where relugolix would be administered for a longer duration of time.
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About Clinical Trials (Clinical Studies) in General
A clinical trial is a research study in which the participants receive investigational medicine(s) under the supervision of a doctor and other research health care professionals to study the effects of a new medicine. Clinical trials follow a strict set of rules to ensure that study participants are protected and that the investigational medicine(s) is tolerated and correctly analyzed for safety and effectiveness. Regulatory authorities, like the Food and Drug Administration (FDA) in the United States, review clinical trial information and make decisions about whether to approve new medicines.
There are 3 phases of clinical trials (clinical studies) before an investigational medicine is considered for approval by a regulatory authority. Phase 1 usually involves a small number of participants to decide on a safe dose followed by Phase 2 and 3 studies which involve larger numbers of participants to test the safety and efficacy (whether it works) of the investigational medicine. The SPIRIT Study is a phase 3 study.
Institutional Review Boards (IRBs) review and approve clinical study protocols. The clinical study protocol is a document that describes how a clinical study will be conducted, including the objective(s) and study design. IRBs ensure the safety of study subjects and ensure the data collected is of high quality.
Click here to go to a helpful resource, ClinicalTrials.gov, where you can learn more about clinical trials and search for other clinical trials.
About Participation, Reimbursement, Permission
Taking part in a SPIRIT Study is a personal decision and may or may not make the pain you have with endometriosis better and may or may not have direct benefit for you. Knowledge from this study may help doctors better understand 1) treatments for patients with pain associated with endometriosis and 2) who is more likely to benefit or who is more likely to have side effects from the investigational medicine. It may also help future patients with endometriosis-associated pain.
When the study is done at all the study sites, the data will be analyzed. People who took part in the study will have an opportunity to learn of the results.
When the first SPIRIT Study is done, participants may qualify for an extension study in which all patients receive the active investigational medicines.
The first step to find out if you are eligible to participate in the SPIRIT Study is to go through the screening process at the clinical site. At your first visit to the study site, you will be asked to review an informed consent form (ICF), which explains the purpose of this research study, the procedures, benefits, risks and precautions. The ICF at each study site is approved by an Institutional Review Board (IRB), a governing board for clinical studies. The IRB is independent of the study doctor and the sponsor.
The screening process includes a review by a doctor and other research health care professionals at the clinical site to see whether you qualify for the study.
The study staff at the clinical site will talk with you about details including the length of the study, the number of visits involved, and the types of tests that are performed at those visits. The study staff will ask you to give them information from your medical records, including surgical diagnosis of endometriosis. You will need to be evaluated by the study staff to decide if you qualify. Only volunteers who meet all of the criteria for the SPIRIT Study can join.
The decision to participate in clinical research study is personal and complex. If you are interested and pre-qualify, you will have the opportunity to carefully review the informed consent for the study and to discuss study details with your primary care provider and family members.
Click here to see additional details about the SPIRIT 1 Phase 3 clinical trial and click here to see additional details about the SPIRIT 2 Phase 3 clinical trial.
As part of the study, you will receive the study drugs, tests, and procedures at no cost to you or your insurance company.
You and your insurance company will continue to pay for your routine tests and services that would be performed as part of your regular health care.
The study team at the clinical site will review any compensation for participation that may apply.
The study team at the clinical site will review possible transportation options with you.
Your decision to be part of the study is completely voluntary and you may drop out without a penalty or impact on your future medical care. If you do decide to stop participation before your part in the study is over, you will be asked to notify the study team before stopping. This is so that you can return to the research center at least 1 more time to have a final “closing” visit to check on your general health and to return any unused study medicines and other supplies.
Click below to see if you are eligible to participate