The MyRose Pregnancy Registry

What is a registry and why is it important?

A pregnancy registry is a study that collects health information from pregnant women, including those who take prescription medicines during pregnancy. Information also is collected on the newborn infant.

Who is eligible to participate?

Patients may be eligible if they are:

  • A resident of the United States
  • A pregnant woman who has:
    • Been diagnosed with uterine fibroids or endometriosis; or
    • Taken MYFEMBREE® during pregnancy or just prior to pregnancy (within 13 days prior to conception)

How do I enroll a patient?

If you have patients who you think may be eligible, you can help them enroll by having them:

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Complete the Contact Request Form here and a registry staff member will contact them

Email the registry team with your contact information at:

Telephone icon

Call the registry team toll-free at
1-877-390-2723
(hours of operation 8.30am – 5.00 pm EST Monday-Friday)

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Download the study database or app by clicking here. When prompted for a registration code enter USA-1703-2163. This option is only available for adults. If you are a minor, please contact the registry directly.

Why is this registry needed?

Uterine fibroids and endometriosis are burdensome female reproductive conditions. Some medications to treat symptoms of these conditions are discouraged for use in pregnancy, but the medications themselves can delay the ability to recognize pregnancy.

Since pregnant women are excluded from clinical trial participation, there is limited data on the potential impact of the safety of medications for the treatment of uterine fibroids or endometriosis during pregnancy on pregnancy and infant outcomes.

Eligible patients and their healthcare providers will provide information to the registry about their pregnancies and the health of their infants up to 1 year of age. This information can be provided by completing paper forms, via the website portal or via a short phone interview with one of the registry staff members. Only information normally documented in patients’ medical records will be collected.

There will be:

  • No extra doctor’s visits or additional testing
  • No changes to patients’ medications or care

Eligible patients and their healthcare providers will receive compensation for providing data to the registry.

The pregnant woman’s healthcare provider(s) will be asked to provide data at enrollment, approximately the end of the second trimester, and pregnancy outcome. For live-born infants, healthcare provider(s) also will be asked to provide data at approximately 4 and 12 months after delivery.

The following data will be collected:

  • Maternal obstetrical history
  • Family history of congenital malformations
  • Uterine fibroid or endometriosis history and location/type of illness
  • Baseline and ongoing pregnancy information, including pregnancy dating and prenatal test information
  • Maternal exposures during pregnancy
  • Maternal medical conditions and pregnancy complications
  • Pregnancy outcome information, including fetus/infant characteristics and presence of congenital malformations
  • Infant growth and development information

Healthcare providers will be compensated when they submit data to the registry.

Eligible patients will be asked to provide information to the registry at enrollment, including basic demographic information (e.g., race, ethnicity, education), height and weight, and information about their history of uterine fibroids or endometriosis.

BOXED WARNING: THROMBOEMBOLIC DISORDERS AND VASCULAR EVENTS

  • Estrogen and progestin combination products, including relugolix-CT, increase the risk of thrombotic or thromboembolic disorders including pulmonary embolism, deep vein thrombosis, stroke and myocardial infarction, especially in women at increased risk for these events.
  • Relugolix-CT is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and those at increased risk for these events, including women >35 years of age who smoke or with uncontrolled hypertension.

Relugolix-CT is contraindicated in patients with the following: high risk of arterial, venous thrombotic, or thromboembolic disorder; pregnancy; known osteoporosis; current or history of breast cancer or other hormone-sensitive malignancies; known hepatic impairment or disease; undiagnosed abnormal uterine bleeding; known hypersensitivity to components of relugolix-CT.

Relugolix-CT is also associated with warnings and precautions for bone loss, suicidal ideation and mood disorders, hepatic impairment and transaminase elevations, elevated blood pressure, changes in menstrual bleeding patterns and a reduced ability to recognize pregnancy, risk of early pregnancy loss, uterine fibroid prolapse or expulsion, and hypersensitivity reactions. Use of relugolix-CT should be limited to 24 months due to the risk of continued bone loss which may not be reversible.

Women should not breastfeed while taking relugolix-CT.

In women with moderate to severe pain associated with endometriosis, the most common adverse reactions reported were headache, vasomotor symptoms, mood disorders, abnormal uterine bleeding, nausea, toothache, back pain, decreased sexual desire and arousal, arthralgia, fatigue, and dizziness.

In women with heavy menstrual bleeding associated with uterine fibroids, the most common adverse reactions reported were vasomotor symptoms, abnormal uterine bleeding, alopecia, and libido decreased.

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

For full prescribing information including Boxed Warning and patient information, please click here.

Thank you for your support in recruiting potential participants.

References

Al-Hendy A, Lukes AS, Poindexter IIII AN. Treatment of uterine fibroid symptoms with relugolix combination therapy. N Engl J Med 2021; 384:630-42.

Fuldeore MJ and Soliman AM. Patient-reported prevalence and symptomatic burden of uterine fibroids among women in the United States: findings from a cross-sectional survey analysis. Int J Womens Health. 2017; 9: 403-411.

Marsh EE, Al-Hendy A, Kappus D, Galitsky A, Stewart EA, Kerolous M. Burden, prevalence, and treatment of uterine fibroids: a survey of U.S. women. J Womens Health. 2018; 27(11): 1359-1367.

Myfembree Prescribing Information. January 2023.

Additional Information

Myfembree Prescribing Information