What is this study trying to find out about hypoparathyroidism?

This study aims to understand how much of the drug palopegteriparatide passes into breast milk when lactating females with hypoparathyroidism are treated with YORVIPATH. Researchers want to learn about drug transfer during breastfeeding. Participants can expect careful collection and analysis of breast milk samples.

Who may be eligible for this hypoparathyroidism clinical trial?

Adults aged 18 to 50 years who are female and currently breastfeeding while treated with YORVIPATH may be eligible. Participants must have been on a stable dose of YORVIPATH for at least 14 days, and breast milk should be the main infant nutrition source. Please review eligibility criteria for more details.

Is there any cost to participate in this hypoparathyroidism clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Age: 18Years - 50Years

FEMALE

ID07264634

Observational Study Measuring Palopegteriparatide Levels in Breast Milk of Lactating Women Treated with YORVIPATH

Led by Ascendis Pharma A/S · Updated on 2026-08-07

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This observational study focuses on lactating female participants who are receiving therapeutic doses of YORVIPATH palopegteriparatide as part of their usual medical care and who have chosen to breastfeed their infants. The purpose is to assess the potential transfer of palopegteriparatide into breast milk, providing important information about exposure during breastfeeding for females with hypoparathyroidism. Participants in this study are lactating females treated with YORVIPATH according to normal clinical practice. The study observes those who have been on a stable daily dose of YORVIPATH for at least 14 days prior to sample collection. This is an opportunistic study that does not involve changes to their treatment but monitors the presence of the drug in breast milk over a six-day period. During the study, participants provide breast milk samples to evaluate the transfer of palopegteriparatide. The main outcome measured is the amount of the drug present in breast milk over six days. Participants continue their usual care and dosing schedules, and researchers collect data without altering treatment. The total participation duration depends on dosing stability and sample collection timing, with no additional interventions beyond monitoring.

CONDITIONS

Brief Title

A Study to Assess the Amount of Palopegteriparatide in Breast Milk of Lactating Females Requiring YORVIPATH® (Palopegteriparatide)

Who Can Participate

Age: 18Years - 50Years

FEMALE

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. The participant must have been taking YORVIPATH for a minimum of 14 days prior to sample collection.
The major source of infant nutrition must be breast milk, with only one supplemental bottle of no more than 8 oz of formula per day allowed during the 14 days before study start.
Daily dose of YORVIPATH administered within the last 14 days has been stable.
Participants recruited from other sources must enroll in the Pregnancy Registry before participating in the Lactation Study.
Written consent or eConsent obtained.

You will not qualify if you...

Presence of any medical condition that may impair the ability to breastfeed during this study, including but not limited to mastitis and nipple malformation.

Research Team

Yorvipath Lactation Inquiries

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here