{"groups":[{"description":"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 of the CS21 study (NCT00295750) as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the CS21 study and the current CS21A study.","id":"FG000","title":"Degarelix 80 mg / Degarelix 80 mg"},{"description":"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 of the CS21 study (NCT00295750) as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the CS21 study and the current CS21A study.\n\nFollowing the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.","id":"FG001","title":"Degarelix 160 mg / Degarelix 160 mg"},{"description":"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.\n\nStarting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.\n\nFollowing the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.","id":"FG002","title":"Leuprolide 7.5 mg / Degarelix 80 mg"},{"description":"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.\n\nStarting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.\n\nFollowing the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.","id":"FG003","title":"Leuprolide 7.5 mg / Degarelix 160 mg"},{"description":"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.\n\nWhen the main CS21 study was completed these patients were switched to treatment with degarelix 80 mg or 160 mg in the CS21A study.","id":"FG004","title":"Leuprolide 7.5 mg"}],"periods":[{"milestones":[{"achievements":[{"comment":"CS21 intention-to-treat (ITT) population.","groupId":"FG000","numSubjects":"210"},{"comment":"CS21 ITT population.","groupId":"FG001","numSubjects":"206"},{"comment":"Participants were switched from the leuprolide 7.5 mg group when CS21 was completed.","groupId":"FG002","numSubjects":"0"},{"comment":"Participants were switched from the leuprolide 7.5 mg group when CS21 was completed.","groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"204"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"169"},{"groupId":"FG001","numSubjects":"163"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"172"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"41"},{"groupId":"FG001","numSubjects":"43"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"32"}],"type":"NOT COMPLETED"}],"title":"CS21 (NCT00295750)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"34"},{"groupId":"FG002","numSubjects":"14"},{"groupId":"FG003","numSubjects":"17"},{"groupId":"FG004","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"4"},{"groupId":"FG004","numSubjects":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"3"},{"groupId":"FG004","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"28"},{"groupId":"FG001","numSubjects":"27"},{"groupId":"FG002","numSubjects":"17"},{"groupId":"FG003","numSubjects":"14"},{"groupId":"FG004","numSubjects":"0"}],"type":"Miscellaneous reasons"}],"milestones":[{"achievements":[{"comment":"CS21A intention-to-treat (ITT) population.","groupId":"FG000","numSubjects":"125"},{"comment":"CS21A ITT population.","groupId":"FG001","numSubjects":"126"},{"comment":"CS21A ITT population.","groupId":"FG002","numSubjects":"69"},{"comment":"One of the enrolled participants never received any treatment, i.e. the CS21A ITT population=65.","groupId":"FG003","numSubjects":"66"},{"comment":"Participants were switched to the degarelix groups when CS21 was completed.","groupId":"FG004","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"60"},{"groupId":"FG001","numSubjects":"49"},{"groupId":"FG002","numSubjects":"27"},{"groupId":"FG003","numSubjects":"27"},{"groupId":"FG004","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"65"},{"groupId":"FG001","numSubjects":"77"},{"groupId":"FG002","numSubjects":"42"},{"groupId":"FG003","numSubjects":"39"},{"groupId":"FG004","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"CS21A (NCT00451958)"}],"preAssignmentDetails":"Initially, participants treated with degarelix during CS21 continued to treatment and patients who received treatment with leuprolide during CS21 were re-randomised to one of the two degarelix treatment regimens. Following a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg for the rest of the study.","recruitmentDetails":"All participants who completed the CS21 study (NCT00295750) were eligible to enrol into the CS21A extension study. Since the number of participants who completed this long-term study was low, no firm conclusions can be drawn from the results."}