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

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  YORVIPATH
• Study drug International non-proprietary name (INN) or common name:
  PALOPEGTERIPARATIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (H05AA05) palopegteriparatide

  palopegteriparatide
• Medical condition to be studied:
  Hypoparathyroidism

Population studied

• Short description of the study population:
  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).
• Age groups:
  • Adults (18 to < 65 years)

    • Adults (18 to < 46 years)
    • Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  10

Study design details

• Main study objective:
  To evaluate the transfer of palopegteriparatide (YORVIPATH®) into human breast milk of lactating female participants who are breastfeeding while being treated with YORVIPATH®.