The MyRose Pregnancy Registry

Future pregnant women with uterine fibroids or endometriosis, their healthcare providers, and researchers may benefit from the information you provide to the registry.

If you are eligible and would like to participate, you will be asked to:

1. Provide your consent (a requirement for participation in any research study)
2. Give the registry permission to contact your healthcare provider(s) to collect information for the study

You and your healthcare provider(s) will give information to the registry about your pregnancy and your infant’s health up to 1 year of age. This information can be provided by completing paper forms, via the website portal or via short phone interviews with one of the registry staff members. Only information normally documented in your medical record will be collected.

If you participate, there will be:

• No extra doctor’s visits or additional testing
• No changes to your existing healthcare provider(s) or care
• No changes to your current treatment

You and your healthcare provider(s) will receive compensation for providing data to the registry.

If you are eligible and would like to participate, you will be asked to provide information to the registry at enrollment and periodically throughout your pregnancy:

• At enrollment, you will be asked to provide basic information about yourself (e.g., race, ethnicity, education, height, and weight) and information about your history of uterine fibroids or endometriosis.
• You will be paid $50.00 for your participation in the Registry. You will be paid $25 after the registry confirms with your healthcare provider that you are eligible and another $25 when your infant reaches 1 year and/or when your infant’s healthcare provider communicates to the Registry Coordinating Center they have no further information available.

Boxed Warning: Relugolix-CT may increase your chances of heart attack, stroke, or blood clots, especially if you are over 35 years old and smoke or have uncontrolled high blood pressure. Stop taking relugolix-CT and call your healthcare provider (HCP) or go to the nearest emergency room right away if you have: leg pain or swelling that won’t go away; sudden shortness of breath; double vision, bulging of the eyes, sudden partial or complete blindness; pain or pressure in your chest, arm, or jaw; sudden, severe headache unlike your usual headaches; weakness or numbness in an arm or leg, or trouble speaking.

Do not take relugolix-CT if you:

• have or have had blood clots in your legs, lungs, or eyes; a stroke or heart attack; a problem that makes your blood clot more than normal; blood circulation disorders; certain heart valve or rhythm problems that can cause blood clots to form in the heart; high blood pressure not well controlled by medicine; diabetes with kidney, eye, nerve, or blood vessel damage; certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision or migraine headaches if you are over 35 years old; breast cancer or any cancer that is sensitive to female hormones; osteoporosis; undiagnosed vaginal bleeding; liver problems;
• smoke and are over 35 years old;
• have had an allergic reaction to any of the ingredients in relugolix-CT.

Relugolix-CT is associated with bone loss (decreased bone mineral density), suicidal thoughts, behavior and worsening of mood; abnormal liver tests; high blood pressure; uterine fibroid prolapse or expulsion; and severe allergic reactions. You should not take relugolix-CT for more than 24 months.

Effects on pregnancy. Do not take relugolix-CT if you are pregnant or trying to become pregnant as it may increase the risk of early pregnancy loss. If you think you are pregnant, stop taking relugolix-CT right away and call your healthcare provider.

Tell your healthcare provider if you are breastfeeding. Relugolix-CT may pass into your breast milk.

The most common side effects in women with heavy menstrual bleeding associated with uterine fibroids are hot flushes, increased sweating, night sweats, abnormal vaginal bleeding, hair loss or thinning, and decreased interest in sex.

The most common side effects in women with moderate to severe pain with endometriosis are headache, hot flushes/sweating/night sweats, mood changes including worsening depression, abnormal vaginal bleeding, nausea, toothache, back pain, decreased interest in sex, joint pain, tiredness, and dizziness.

These are not all the possible side effects of relugolix-CT.

For a copy of the full prescribing information, please click here.