Premenarchal Sample Clauses

Premenarchal. 2. Premenopausal female with 1 of the following: − Documented hysterectomy − Documented bilateral salpingectomy − Documented bilateral oophorectomy For individuals with permanent infertility due to an alternate medical cause other than the above, (eg, Mullerian agenesis, androgen insensitivity), investigator discretion should be applied to determining study entry eligibility. Note: Documentation can come from the site personnel’s review of the subject’s medical records, medical examination, or medical history interview. Postmenopausal female • A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. − A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation with more than one FSH measurement is required. • Females on HRT and whose menopausal status is in doubt will be required to use one of the non-estrogen hormonal highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment.