This clinical research study is evaluating an investigational medication to see if it may safely and effectively reduce bleeding during your period. The investigational medication works by partially blocking the production of estrogen and progesterone that affect the growth of your uterine fibroids.
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. Other symptoms include:
Not all women who have been diagnosed with uterine fibroids have symptoms. But if you do have symptoms, you may find them extremely disruptive to your daily activities.
I have personally worn more than one pad at a time trying to get peace of mind and not bleed through my clothing.
Whether you want to explore other options for your condition or to help develop future treatments for others, choosing to participate in a clinical research study is a very personal decision.
If you qualify for the My Fibroid Study and decide to participate, you will receive all study-related care at no charge, including:
Your insurance company will not be notified of your participation.
Accidents during your cycle are some of the most embarrassing moments you can have.
A clinical trial, also referred to as a research study, is a scientific study that evaluates the safety and effectiveness of an investigational medication. A clinical trial may show that the investigational medication is better than, as good as, or no better than the standard treatment or inactive placebo. Qualified doctors, nurses and other medical professionals conduct the clinical trial.
It is only through the completion of clinical trials that investigational medications can be evaluated, and if proven safe and effective, approved for general use by the U. S. Food and Drug Administration (FDA). All prescription medications in use today were first proven safe and effective in clinical trials.
Only volunteers who meet all of the eligibility criteria for a study may participate. The study staff 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 the study. You may also be asked to provide information from your medical records to help the study staff determine if you qualify.
Yes, participation in any clinical trial is completely voluntary. If you decide to participate in a clinical trial, you are always free to withdraw at any time, for any reason, without any penalty or effect on your future medical care.
The study is being conducted to evaluate if the investigational medication being tested may reduce the amount of bleeding during your heavy periods associated with uterine fibroids.
The research will assess heavy periods associated with uterine fibroids in approximately 800 study participants. It will be conducted at about 250 research sites in the U.S., Canada, and Puerto Rico.
An investigational study medication is a medication that has not yet been approved by the FDA for prescription by doctors. The medication that is being tested in this clinical research study is investigational.
A placebo, also known as a "sugar pill," contains no active medication. A placebo is used in clinical trials to determine if the active medication being evaluated is safer and more effective than no treatment at all. There is a chance that you will receive a placebo during this study.
Information about your personal health is private and confidential. With your permission, the information you provide about your medical history and health condition can be transferred to the study doctor's office of your choice.
If you pre-qualify for the study, a representative from the study doctor's office will contact you to further determine your interest and eligibility. Your personal information will not be disclosed to anyone outside of this clinical trial study group without your consent unless disclosure is required by law or regulations of the FDA or similar agencies in other countries.
Scientific presentations of study results will not include information that could in any way identify you.
The research site will be happy to spend the time with you to discuss the medical aspects of the study. If you qualify and decide you want to take part, you will be given a written document called an Informed Consent Form that puts down in writing the study's purpose, and the procedures, benefits, risks, discomforts, and precautions of the study. You will have the opportunity to ask questions and decide if taking part is right for you.
You will be asked to review and sign an "Informed Consent Form" prior to study participation.
If you qualify and sign the Informed Consent Form, you will be enrolled into the clinical trial.
Once enrolled, you will come to the research site for periodic visits for study exams to evaluate your general health and your symptoms.
Feel free to discuss your study-related medical care with the study physician or staff at any time during the course of the research study. It is important to take all study medication as prescribed and attend all scheduled visits. You will answer questions regarding how you feel during your participation and whether the investigational medication has been taken at the appropriate times.
The study will last approximately 21 months. You will need to make 16-22 visits to the study offices during that time. If you pre-qualify and are referred to the research office, the study staff can provide you with more information.
Your participation in the trial is entirely voluntary and you may withdraw at any time. If you decide to withdraw early from the trial, 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.
Compensation may be provided. The research staff can advise you about this if you pre-qualify and are referred to the research site.
There is no charge for taking part. All examinations, doctor visits, procedures and medications related to the study are provided at no charge.
Your doctor does not have to give his/her permission for you to participate. However, either you or the doctor conducting the study, with your permission, may contact your personal doctor to discuss your participation in the study before you begin and to keep your doctor up-to-date about your progress.