What is the YORVIPATH®
Lactation Safety Study?
The YORVIPATH Lactation Safety Study is evaluating how much YORVIPATH (palopegteriparatide) passes into breast milk in women who are breastfeeding while taking YORVIPATH.
This is an observational study, meaning you and your baby will continue to receive routine medical care from your own doctors. No extra visits, tests, or procedures are required. However, you must agree to a 24-hour collection period of your breast milk and agree to two home visits by the study nurse.
Why Participate?
Participation is completely voluntary. By joining, you can help doctors and researchers learn more about the safety of YORVIPATH. The information collected may also guide future care for pregnant and breastfeeding women and their babies.
You may be compensated up to $500 for your time and participation.
Who Can Join?
This study is for women aged 18 or older who are enrolled in the YORVIPATH Pregnancy Safety Study and are breastfeeding while taking YORVIPATH.
What to Expect
This study takes about 2 days in total. It includes a 24-hour breast milk collection that begins at least 2 weeks after your baby is born. A study nurse will also visit you at home twice—once before collection to show you how to use the breast pump and properly collect and store the samples, and once after the collection to pick up the samples. These visits will be scheduled at times that work best for you.
Before the collection starts, your baby's main source of nutrition should be breast milk. During this time, you may give up to one small bottle of formula each day (no more than 8 oz). During the 24-hour collection period, you may use as much supplemental formula as needed.
A shipment of study supplies will be sent to your home, including a medical grade electric breast pump (yours to keep), a digital scale, for weighing your breast milk collection, containers and a cooler.
Privacy Protection
Your personal and medical information will remain confidential. All identifying details will be removed before data is used for research.
About YORVIPATH
YORVIPATH is an FDA-approved treatment for hypoparathyroidism in adults. However, there is not enough information yet to establish the safety of Yorvipath in women who are breastfeeding. This registry helps gather important information about its use during and after pregnancy to better understand effects on mothers and babies. For more information on YORVIPATH please refer to the prescribing information that comes with your medication.
To find out if you are eligible to join the Lactation Safety Study: call 877-229-2184, M-F, 8-8 ET or email us at: Yorvipathlactation@ubc.com. To report a pregnancy click here.