Summary:
We know that it’s not easy to manage the pain and other symptoms of endometriosis. Because it doesn’t show on the outside, your family, friends, and colleagues may not understand what you’re going through. You know the pain others can only imagine.
The SOLSTICE clinical research study is for women just like you who are dealing with endometriosis pain.
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.
Can I participate in the study?
You may be able to join the study if you:
- Are 18 to 49 years old and have not gone through menopause
- Have been surgically diagnosed with endometriosis in the past 10 years and have moderate to severe endometriosis-associated pain symptoms during your period and at other times in your menstrual cycle
- Are not taking pain medication to treat a chronic disease other than endometriosis, such as painful bladder syndrome, adenomyosis or fibromyalgia
- Do not have a history of osteoporosis or another bone disease
- Are not pregnant or breastfeeding or planning to get pregnant within the next 24 months
There are other requirements to be in the study that the study doctor will discuss with you to determine if you are eligible to participate.
What are the study drugs?
The investigational drug is a tablet taken by mouth that reduces 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 investigational drug but has no active drug in it.
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 for 6 months. You will have a 57 percent chance (4 in 7) of receiving the active investigational drug tablets and a 43 percent chance (3 in 7) of receiving placebo tablets.
How long is the study?
Your participation in the study may last up to approximately 20 months. 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.
Why should I consider participating?
Participating in a study is a way to learn more about your disease and how to take care of your health. As a study participant, your endometriosis will be closely monitored under the guidance of a gynecologist. You will receive all investigational study medications and study-related tests and procedures at no cost. Although you may not benefit directly from being in the study, the information gathered in the study may help women with endometriosis in the future.
Study participation is voluntary, and you can leave the study at any time. Talk with your doctor, family, and friends, and ask the study doctor questions about the study before you decide to participate.
The study doctors and their staff respect your privacy. Details about your health will not be shared with anyone who is not associated with this research study unless you have given your permission or except as required by law.