If you have been living with heavy periods, it may be due to uterine fibroids. You may be eligible to participate in a research study that is evaluating an investigational oral medication for uterine fibroids.
The Asteroid Studies are research studies evaluating the safety and effectiveness of an investigational oral medication for uterine fibroids. Fibroids require the hormone progesterone for their growth and development. The purpose of these studies is to find out whether the investigational oral medication may reduce fibroid-related symptoms by blocking the effect of progesterone on the cells of the body. 1
Uterine fibroids are noncancerous growths in the wall of the uterus (womb). The most common symptom of fibroids is heavy periods.2 Other symptoms may include:
Pain during sex2
Lower back pain2
Frequent urination2 or difficulty urinating
When I have heavy periods, I have to plan ahead. It takes a lot of my time and thinking.
If you qualify and decide to participate, you may receive:
Your participation may help advance medical knowledge of uterine fibroids.
The Asteroid Studies are designed to evaluate the safety and effectiveness of an investigational oral medication in patients with uterine fibroids.
The medication you receive will be assigned by a process called randomization, which is like flipping a coin. Your doctor is not able to influence which medication you will be assigned to. Once you have been assigned to a group, the study staff will be able to explain your chances of receiving the investigational oral medication.
The Asteroid Studies are being conducted by qualified physicians and other medical specialists in countries around the world.
You will have periodic visits to the study doctor’s office, during which a variety of exams and tests will be performed. You will also be asked to record symptoms and other information at home on an electronic diary. The study staff will provide more complete details about your role.
If you qualify and decide to participate, you will be given a document called an Informed Consent Form, which details procedures involved as well as the benefits and risks of participating in the study. You will be able to ask any questions you have about the study before signing the Informed Consent Form and agreeing to participate.
No. If you qualify for this research study, study-related medication and care will be provided to you at no cost. You will also receive close monitoring by the study doctor and experienced staff, nonhormonal birth control (as needed) and feminine hygiene products during your regular visits.
There are potential risks to taking part in any research study. There is also the possibility that you may not benefit from this research study. The study staff will discuss the possible risks and potential benefits in detail with you before you decide to participate.
Yes, participation in any research study is completely voluntary. You are free to withdraw at any time for any reason without any penalty or effect on your future medical care.
The information you provide will not be shared with anyone who is not directly associated with this research program without your permission (except as required by law). Your personal information will be stored using codes that do not identify you and it will not be linked to publicly released information about the study.
After the research study is complete, all of the information is collected and analyzed to help determine the safety and effectiveness of the study medication.
No. However, it is a good idea to let your doctor know that you plan to participate in this research study. With your permission, your doctor may contact the study doctor for more information at any time.
Reasonable compensation may be provided.
Bayer AG is sponsoring the Asteroid Studies.
Research studies evaluate new ways to prevent, detect, diagnose, or treat diseases. They help determine whether investigational medications are safe and effective. Government rules help protect the rights and safety of participants in research studies. To learn more about research studies, visit https://clinicaltrials.gov/ct2/about-studies/learn.
Informed consent is the process of learning the key facts about a research study before you decide to participate. It is also a continuing process throughout the study to provide information for participants. The doctors and nurses involved with the study will explain the details of the study and then provide you with an Informed Consent Form to read. This document includes details about the purpose, duration, and required procedures of the study as well as any risks and potential benefits. The study staff is there to help answer any questions you may have. After reviewing the Informed Consent Form, you will decide whether or not to sign it. No study-related procedures can take place before you have signed the Informed Consent Form.
An investigational medication is a drug that is not approved for prescription use for the condition or population being studied. Investigational medications are tested during research studies to see if they are safe and effective for a specific medical condition and/or group of people.
To help ensure that a research study is ethical and that participants’ rights are protected, Institutional Review Boards (IRBs) or Ethics Committees (ECs) review and approve study protocols.
Only volunteers who meet all of the eligibility criteria for a study may take part. The study team will review your medical history and current medical status against the eligibility criteria. You may also be asked to provide information from your medical records to help the study team determine whether you qualify.