Hypoparathyroidism
Conditions
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.
Interventions
Palopegteriparatide prescribed as per normal clinical practice
Sponsors
Ascendis Pharma A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the transfer of palopegteriparatide into human breast milk of lactating female participants who are breastfeeding while being treated with YORVIPATH | 6 days |
Countries
United States
Contacts
CONTACTYorvipath Lactation Inquiries
STUDY_DIRECTORMedical Director, MD
Ascendis Pharma A/S
Outcome results
None listed