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Observational Study of Palopegteriparatide in Breast Milk

This study is looking at how much of the medicine palopegteriparatide (YORVIPATH®) gets into breast milk. This is for women who are already taking YORVIPATH for hypoparathyroidism (a condition where your body doesn't make enough parathyroid hormone) and have chosen to breastfeed. Researchers want to understand if the medicine transfers to breast milk. You can join if you are a woman between 18 and 50 years old, are breastfeeding, and have been taking YORVIPATH for at least 14 days as part of your regular medical care. The study aims to measure the amount of palopegteriparatide in breast milk after 6 days. The current recruitment status is unclear, and the study plans to enroll 10 participants.

Study design
This is an observational study, meaning researchers will watch what happens without making changes to your treatment. It plans to include 10 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary measurement of palopegteriparatide in breast milk will be taken at 6 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07264634

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

Recruiting
Not specifiedAges 18–50Observational
Ascendis Pharma A/S
~10 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:Palopegteriparatide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the transfer of palopegteriparatide into human breast milk of lactating female participants who are breastfeeding while being treated with YORVIPATH
Measured over 6 days

Conditions

Hypoparathyroidism

Explore related trials

Hypoparathyroidism

Where it's being run

1 sites across 1 states
West Virginia1

Study leadership

  • Medical Director, MD · STUDY_DIRECTOR · Ascendis Pharma A/S

Who to contact

Yorvipath Lactation Inquiries
[email protected]
877-229-2184
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Eligibility criteria

Inclusion

1\. 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. Note: The participant must have been taking YORVIPATH for a minimum of 14 days prior to sample collection.
2\. The major source of infant nutrition must be breast milk (Note: Only one supplemental bottle of no more than up to 8 oz of formula per day will be allowed during the 14 days before start of the study).
3\. Daily dose of YORVIPATH administered within the last 14 days has been stable.
4\. Participants recruited from other sources must enroll in the Pregnancy Registry before being allowed to participate in the Lactation Study.
5\. Written consent or eConsent obtained.

Exclusion

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

What this trial measures

  • To evaluate the transfer of palopegteriparatide into human breast milk of lactating female participants who are breastfeeding while being treated with YORVIPATH6 days