Enrollment and trial design
amenorrhea
The Department of Urology at the Hospital Center in Biel is conducting the GAIN-INST Trial in which from September 2022 for two years, patients with intermediate-risk NMIBC are recruited according to the criteria in Table Inclusion and exclusion criteriaFemale subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 6 months after the last treatment. Note: Women not of childbearing potential are defined as:postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women < 45 years of age a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.) OR have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening; OR has a congenital or acquired condition that prevents childbearingTrial design