Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT07264634
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT07264634
Study Brief:
Protocol Section:
NCT07264634