Status:

RECRUITING

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

Lead Sponsor:

Ascendis Pharma A/S

Conditions:

Hypoparathyroidism

Eligibility:

FEMALE

18-50 years

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 ...

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

Key Trial Info

Start Date :

March 19 2026

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 1 2028

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT07264634

Start Date

March 19 2026

End Date

January 1 2028

Last Update

April 17 2026

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Ascendis Investigational Site

Morgantown, West Virginia, United States, 26508