Actively Recruiting
A Study to Assess the Amount of Palopegteriparatide in Breast Milk of Lactating Females Requiring YORVIPATH4 (Palopegteriparatide)
Led by Ascendis Pharma A/S · Updated on 2026-04-17
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an observational study to understand how much palopegteriparatide passes into breast milk in lactating women who are being treated with YORVIPATH for hypoparathyroidism. The study focuses on women who have chosen to breastfeed while receiving this medication as part of their usual care. It aims to provide important information about the medication's transfer during breastfeeding. Participants in this study are lactating females currently taking palopegteriparatide under normal clinical care. The study observes these women without altering their treatment, tracking the medication levels in breast milk. The main study period lasts 6 days during which breast milk samples will be collected to evaluate the transfer of the drug. During participation, women will provide breast milk samples over the 6-day observation period. Researchers will assess the amount of palopegteriparatide in the milk to understand potential exposure to infants. Participants must have stable doses of the medication and primarily breastfeed their infants. The study includes informed consent and follows the participants' usual medical care throughout.
CONDITIONS
Brief Title
A Study to Assess the Amount of Palopegteriparatide in Breast Milk of Lactating Females Requiring YORVIPATH® (Palopegteriparatide)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Lactating female participants 18 years of age or older treated with YORVIPATH as part of their usual medical care and who have chosen to breastfeed
- Must have been taking YORVIPATH for at least 14 days prior to sample collection
- The major source of infant nutrition must be breast milk, with no more than one supplemental bottle of up to 8 oz of formula per day during the 14 days before the study
- Daily dose of YORVIPATH administered within the last 14 days has been stable
- Participants from other sources must enroll in the Pregnancy Registry before participating
- Written consent or eConsent must be obtained
You will not qualify if you...
- Any medical condition that may impair the ability to breastfeed during this study, such as mastitis or nipple malformation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 days
Participants provide breast milk samples to assess the amount of Palopegteriparatide transferred during breastfeeding.
Multiple visits over 6 days for sample collection
Trial Site Locations
Total: 1 location
1
Ascendis Investigational Site
Morgantown, West Virginia, United States, 26508
Actively Recruiting
Research Team
Y
Yorvipath Lactation Inquiries
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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