Introduction
Methods
Study ID, location; number of patients | Study design | Treatment (triptorelin formulation); duration | Primary endpoints | Assay (sensitivity) |
---|---|---|---|---|
DEB-96-TRI-02 South Africa; n = 30 | Phase II, open, 1-arm | Pamoate 3.75 mg (1-month) IM on days 0 and 28; 2 months | Response (inhibition of FSH and LH secretion) Triptorelin levels on days 0 and 28 Reduction of testosterone levels from day 0 to 56 |
125I-RIA Kit (LOD 6 ng/dl)b
|
DEB-99-TRI-04 South Africa; n = 69 | Phase II, multicentre, single-blind, randomised, controlled, parallel group | Pamoate 3.75 mg (1-month) IM Acetate 3.75 mg (1-month) IM, both on days 1 and 29; 2 months | Testosterone pharmacodynamics |
125I-RIA Kit (LOD 6 ng/dl)b
|
DEB-TRI6M-201 Bulgaria; n = 24 (8a) | Phase II, single-blind, randomised, controlled, 3-arm | Pamoate 22.5 mg (6-month) IM; 6 months | Achievement of castrate testosterone levels on day 29 Maintenance of castrate levels from days 57 to 169 | Solid-phase RIA (direct/extracted) (LOD 1 ng/dl) |
E47-52014-402L UK; n = 70 | Phase II, multicentre, open, randomised | Pamoate 11.25 mg (3-month) IM Acetate 3 mg (1-month) IM on days 0, 28, 56; 3 months | Testosterone level at month 3 (day 84) | Direct RIA (LOD 5 ng/dl) |
E28-52014-701 South Africa, France, UK; n = 131 | Part I: phase II, multicentre, open, randomised, 2-arm Part II: open extension, 1-arm | Acetate 11.25 mg (3-month) IM Acetate 3 mg (1-month) IM every 28 days; 3 months Acetate 11.25 mg (3-month) IM on days 91–273; 6 months | % Patients with testosterone levels ≤50 ng/dl at day 84 | RIA (LLOQ 5 ng/dl) |
DEB-96-TRI-01 1st South Africa; n = 335 | Phase III, multicentre, randomised, controlled, 2-arm | Pamoate 3.75 mg (1-month) IM every 28 days Pamoate 11.25 mg (3-month) IM every 84 days; 9 months | Achievement of testosterone castration levels at month 1 Maintenance of castration levels from month 2 to 9 |
125I-RIA Kit (LOD 6 ng/dl)b
|
DEB-96-TRI-01 2nd South Africa; n = 277 (137a) | Phase III, multicentre, randomised, controlled, 2-arm | Pamoate 3.75 mg (1-month) IM every 28 days; 9 months | Achievement of testosterone castration levels at day 29 Maintenance of castration levels from month 2 to 9 |
125I-RIA Kit (LOD 6 ng/dl)b
|
DEB-TRI6M-301 South Africa; n = 120 | Phase III, multicentre, open-label, 1-arm | Pamoate 22.5 mg (6-month) IM on days 1 and 169; 12 months | Achievement of testosterone castration levels at day 29 Maintenance of castration levels from month 2 to 12 | LCMS/MS (LLOQ 3 ng/dl) |
DEB-01-TRI-04 South Africa; n = 20 | Phase IV, open-label, 1-arm | Pamoate 11.25 mg (3-month) IM on days 1, 85, and 169; 9 months | % Castrated patients on days 87 and 171, two days after re-exposures to triptorelin pamoate | DiaSorin RIA (LOD 2.9 ng/dl) |
Results
Triptorelin formulation | 1 month (3.75 mg) | 3 month (11.25 mg) | 6 month (22.5 mg) | All |
---|---|---|---|---|
Patients enrolled | 489 | 303 | 128 | 920 |
Age (years) | 71.1 (42–96) | 70.5 (48–93) | 71.1 (51–93) | 70.9 (42–96) |
Weight (kg) | 74.2 (40–129) | 74.6 (38–132) | 83.3 (47–136) | 75.8 (38–136) |
BMI (kg/m2) | 24.8 (13–43) | 25.2 (16–44) | 27.6 (19–42) | 25.4 (13–44) |
Testosterone (ng/dl) | 358.6 (3–1015) | 383.1 (40–1296) | 502.6 (54–1171) | 386.7 (3–1296) |
Racea, n (%) | 421 (100) | 240 (100) | 128 (100) | 789 (100) |
Caucasian | 231 (54.9) | 147 (61.2) | 85 (66.4) | 463 (58.7) |
Black | 128 (30.4) | 65 (27.1) | 27 (21.1) | 220 (27.9) |
Coloured | 61 (14.5) | 27 (11.3) | 16 (12.5) | 104 (13.2) |
Other | 1 (0.2) | 1 (0.4) | 0 (0) | 2 (0.2) |