About Clinical Research
Study #0009

• For individuals Assigned Male at Birth (AMAB), no contraception is required.
• Individuals are considered Not of Childbearing Potential (INOCBP) if they are not capable of producing ova or embryo, and/or are not capable of potentially gestating a fetus. This includes:
  • have a congenital anomaly such as Müllerian agenesis, resulting in confirmed infertility
  • are infertile due to surgical sterilization
    • hysterectomy
    • bilateral salpingo-oophorectomy
    • bilaterial salpingectomy
    • bilateral oophorectomy
  • are menopausal.
    • at any age at least 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy, confirmed by operative note; or
    • aged at least 40 years and up to 55 years with an intact uterus, not on hormone therapy, who has had cessation of menses for at least 12 consecutive months without an alternative medical cause
    • 55 years or older not on hormone therapy, who has had at least 12 months of spontaneous amenorrhea, or
    • aged at least 55 years with a diagnosis of menopause prior to starting hormone replacement therapy.
  • Individuals assigned female at birth are considered Individuals of childbearing potential (IOCBP) unless they meet the conditions outlined above for INOCBP. IOCBP individuals must meet the below criteria:
    • Abstinent as their preferred lifestyle

Agree to use 1 highly effective method of contraception or a combination of 2 effective methods of contraception