What is the purpose of the study?
The purpose of the study is to evaluate the safety and effectiveness of an investigational drug for moderate to severe endometriosis pain symptoms. To learn more about the study, watch this brief video located HERE.
What are the study drugs?
The investigational drug is a tablet taken by mouth that is designed to reduce the production of estrogen in the ovaries, one of the hormones associated with endometriosis pain. This study will evaluate whether the investigational drug may help manage the painful symptoms associated with endometriosis. The investigational drug is not approved by regulatory agencies as a treatment for endometriosis pain.
In this study, the investigational drug will be compared to placebo. Placebo looks the same as the investigational drug but has no active drug in it.
What study drugs will I receive?
If you qualify for and choose to participate in the study, you will be randomly assigned by chance to receive either active investigational drug or placebo. You will have a 57 percent chance (4 in 7) of receiving active investigational drug tablets and a 43 percent chance (3 in 7) of receiving placebo tablets.
What other medications are allowed?
You will receive approved pain medications to take during the study to manage your endometriosis pain symptoms (as needed), as well as the study drug.
There are some medications, such as hormonal contraceptives, that you cannot take during the study. You may need to stop taking these medications at the time you enter the study. You may also need to stop taking some types of pain medications you are currently taking for your endometriosis pain.
How long is the study?
Your participation in the study may last up to approximately 20 months.
What happens during the study?
Before you participate in this study, you will receive a study Informed Consent Form that provides a detailed description of the study including possible risks. The study staff will explain anything you do not understand and answer any questions you may have. Before any study procedure is performed, you will be asked to sign the Informed Consent Form after all your questions have been answered to confirm you agree to participate in the study.
You will visit the study center about 14 times and talk to study staff via telephone about 7 times during the study. At study visits, you will have tests and procedures to check your health.
The study has four periods:
- Washout Period, if applicable (up to 12 months before you enter the Screening Period)—If you take birth control or other hormonal therapies, you will have to stop taking these medications so that the medications can leave your body before you begin taking the assigned study drug. You will be asked to start using non-hormonal methods of birth control during this period and for the duration of the study (provided at no cost). You will receive counseling on the importance of consistent, appropriate and effective use of birth control.
- Screening Period (up to 100 days before receiving your first dose of study drug)—The study doctor will talk to you and run some tests to determine if you qualify for the study. You will be given an electronic diary (e-diary) to take home and use to record information about your endometriosis symptoms and medication use. You will need to enter a minimum of 45 daily e-diary entries during this period.
- Study Treatment Period (6 months)—You will visit the study center once a month for a check-up and to receive your assigned study drug. You will take the study drug twice a day (3 tablets in the morning and 2 tablets in the evening). You will continue to make daily diary entries throughout this period. When you complete the 6-month Study Treatment Period, you will have two options based on whether you have experienced side effects of the study drug:
- Receive active study drug in a separate 6-month extension study or
- Enter the Follow-up Period of the study and no longer receive study drug
- Follow-up Period (up to 12 months)—You will visit the study center to have tests to check your health or the study staff will call you to ask how you are feeling.
What are the potential known risks and benefits?
The study doctor will explain all of the potential known risks and benefits of taking the study drugs and of study-related tests and procedures.
Why should I consider participating?
Participating in a study is a way to learn more about your condition and how to take care of your health. As a study participant, your endometriosis will be closely monitored under the guidance of a study gynecologist. You will receive all investigational study medications and study-related tests and procedures at no cost. Although you may not benefit from being in the study, the information gathered in the study may help women with endometriosis in the future.
Qualified participants who complete the study will be eligible to receive up to $1,000 in compensation for time and travel.