The information you provide is completely confidential and will only be disclosed with your permission except as required by law. If you pre-qualify, your answers will be submitted to the study team to discuss your possible participation.
Uterine fibroids are noncancerous growths that develop in the wall of your uterus. The most common symptom of uterine fibroids is heavy bleeding during your period.
The My Fibroid Study is evaluating an oral study drug to see if it may reduce heavy periods associated with uterine fibroids.
This research study will be conducted at about 160 study centers in the US and Puerto Rico and will enroll approximately 600 participants after they qualify. The research study is part of the Elaris Program, which is studying the safety and effectiveness of the investigational oral medication for various health conditions.
After you pre-qualify, the study staff will tell you about other tests and procedures you may need to do to meet additional study criteria. As part of this process, you will be asked to read and sign a document called the Informed Consent Form (ICF). The ICF explains the purpose of the research study, procedures, benefits, risks, and precautions.
If you qualify and enroll, you will have regular study visits, both in the office and over the phone. Study-related exams, procedures and questionnaires will evaluate your uterine fibroid symptoms and general health. You will also be asked to keep a daily electronic diary for part of the study to measure some of your uterine fibroid symptoms. It is important that you follow all study procedures and attend all scheduled study visits.
The study doctor and study staff are always available to discuss your health and study-related care, as well as answer any questions you may have.
AbbVie is the sponsor of this research study. To learn more about the sponsor, visit abbvie.com.
About the Study Drug and Other Medications
An investigational study drug 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.
During the first half of the treatment period, there is a chance that you may receive a placebo. A placebo resembles the oral study drug, but it contains no active medication. However, there is no placebo in the second half of this research study and all participants will receive the oral study drug.
In previously conducted clinical research studies, 3790 women have taken the same oral investigational study drug that is being evaluated in the My Fibroid Study.
A placebo pill, also called a sugar pill, has no active ingredient or drug. In order to determine whether the study drug works to reduce the amount of menstrual blood loss associated with uterine fibroids, some study women will take a placebo in the Year 1 Treatment Period. This is the best way to determine if the study drug works “better” than the placebo pill. Women receiving a placebo are just as important to the overall study results as those receiving study drug.
The study staff will review all your current medications with you and let you know if you need to stop taking any of them to participate. However, do not stop taking any of your current medications without first discussing it with the study staff.
Privacy, Participation, Reimbursement, and Permission
There is no cost 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. You will also receive sanitary products and non-hormonal contraception (as needed).
Yes. Your participation in this research study is entirely voluntary and you may withdraw at any time. If you decide to withdraw early from this clinical research study, you will be asked to notify the study staff before doing so. You will be asked to return to the research study center at least once to complete a final visit and return any unused study drugs and other supplies.
If you pre-qualify and are referred to a nearby study center, the study staff can discuss compensation that may be available.
You do not need your primary doctor’s permission to participate. However, you may want to discuss the My Fibroid Study with your primary doctor before deciding to participate. Also, the study staff can keep your doctor up to date with your progress in the research study if you give the study staff permission to do so.
About Clinical Research Studies
A clinical research study, also known as a clinical trial, is conducted to evaluate the safety and effectiveness of an investigational study drug compared to standard care or placebo. If the study drug is proven to be safe and effective during a clinical research study, 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 heavy menstrual bleeding associated with uterine fibroids.
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 study drugs can be evaluated. For more information about clinical research studies in general, visit https://clinicaltrials.gov/ct2/about-studies.
To help ensure that a 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 research study may take part. The study staff at the study center 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.