TABLE 1.
Study ID; location | Study design; number of patients | Study population | Treatment formulation evaluated | Treatment period |
---|---|---|---|---|
DEB‐96‐TRI‐01 first phase; South Africa | Phase III, 19 centres, open‐label, randomised, controlled, 2‐arm; N = 335 | Advanced prostate cancer |
Triptorelin pamoate 3.75 mg IM every 4 weeks Triptorelin 11.25 mg IM every 12 weeks |
9 months (252 days) |
DEB‐96‐TRI‐01 second phase; South Africa | Phase III, 29 centres, open‐label, randomised, controlled, 2‐arm; N = 277 | Advanced prostate cancer | Triptorelin pamoate 3.75 mg IM every 4 weeks | 9 months (252 days) |
DEB‐TRI6M‐301; South Africa NCT00751790 | Phase III, 13 centres, open‐label, 1‐arm; N = 120 | Advanced prostate cancer | Triptorelin pamoate 22.5 mg IM every 24 weeks | 12 months (336 days) |
Abbreviation: IM, intramuscular.