NCT07264634 A Study to Assess the Amount of Palopegteriparatide in Breast Milk of Lactating Females Requiring YORVIPATH® (Palopegteriparatide)
| NCT ID | NCT07264634 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ascendis Pharma A/S |
| Condition | Hypoparathyroidism |
| Study Type | OBSERVATIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-03-19 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10 participants in total. It began in 2026-03-19 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an observational, opportunistic lactation study to be conducted in lactating female participants who are currently receiving therapeutic doses of YORVIPATH as part of their usual care and who have chosen to breastfeed their infant(s). The potential transfer of palopegteriparatide into breast milk will be assessed.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Medical Director, MD
STUDY DIRECTOR
Ascendis Pharma A/S
Frequently Asked Questions
Who can join the NCT07264634 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Hypoparathyroidism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07264634 currently recruiting?
Yes, NCT07264634 is actively recruiting participants. Contact the research team at yorvipathlactation@ubc.com for enrollment information.
Where is the NCT07264634 trial being conducted?
This trial is being conducted at Morgantown, United States.
Who is sponsoring the NCT07264634 clinical trial?
NCT07264634 is sponsored by Ascendis Pharma A/S. The principal investigator is Medical Director, MD at Ascendis Pharma A/S. The trial plans to enroll 10 participants.