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

Part of paid clinical trials in Morgantown, West Virginia.

Sponsor
Ascendis Pharma A/S
Study ID
NCT07264634
Status
Recruiting
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Conditions

  • Hypoparathyroidism

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Dec 4, 2025
Start date
Mar 19, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
10 participants (estimated)

Arms

  • Arm: Palopegteriparatide
    Pregnant women exposed to palopegteriparatide during pregnancy

Primary Outcome Measure

To evaluate the transfer of palopegteriparatide into human breast milk of lactating female participants who are breastfeeding while being treated with YORVIPATH [ Time Frame: 6 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ascendis Investigational SiteMorgantownWest Virginia26508-

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Ascendis Investigational Site· Morgantown, WV

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