Table 1.
Patients' characteristics (safety population).
| Characteristic | Placebo group | BMT groups |
|||
|---|---|---|---|---|---|
| 0.75 mg | 1.25 mg | 1.75 mg | 1.25/1.75 mg pooled | ||
| All patients | |||||
| n | 97† | 100 | 99† | 98 | 196 |
| Age (years), mean (SD) | 37.0 (7.7) | 37.6 (7.8) | 35.7 (7.2) | 37.0 (7.6) | 36.4 (7.4) |
| Race, n (%): – White | 75 (77) | 71 (71) | 65 (66) | 70 (71) | 135 (69) |
| – Black | 19 (20) | 25 (25) | 32 (32) | 23 (23) | 55 (28) |
| – Other | 3 (3) | 4 (4) | 2 (2) | 5 (5) | 7 (4) |
| Weight at screening (lbs), mean (SD) | 164.4 (42.1) | 168.2 (37.9) | 174.0 (43.2) | 179.2 (45.9)‡ | 176.5 (44.5)§ |
| BMI at screening (kg/m2), mean (SD) | 27.7 (6.2) | 28.5 (6.6)¶ | 29.2 (7.1) | 29.9 (7.2)‡ | 29.5 (7.1)§ |
| FSD diagnosis, n (%): | |||||
| – FSAD | 4 (4) | 3 (3) | 3 (3) | 2 (2) | 5 (3) |
| – HSDD | 24 (25) | 20 (20) | 24 (24) | 24 (24) | 48 (24) |
| – Mixed | 69 (71) | 77 (77) | 72 (73) | 72 (73) | 144 (73) |
| Menses frequency regular, n (%) | 72 (74) | 75 (75) | 86 (87) | 79 (81) | 165 (84) |
| Used oral contraception within the 30 days before screening, n (%) | 12 (12) | 15 (15) | 11 (11) | 15 (15) | 26 (13) |
| Patients with primarily or solely HSDD | |||||
| n | 81 | 87 | 87 | 85 | 172 |
| Age (years), mean (SD) | 36.3 (7.7) | 37.6 (7.9) | 35.9 (7.1) | 37.4 (7.6) | 36.6 (7.4) |
| Race, n (%): – White | 66 (82) | 63 (72) | 59 (68) | 64 (75) | 123 (72) |
| – Black | 13 (16) | 22 (25) | 27 (31) | 16 (19) | 43 (25) |
| – Other | 2 (3) | 2 (2) | 1 (1) | 5 (6) | 6 (4) |
| Weight at screening (lbs), mean (SD) | 162.8 (40.9) | 171.7 (38.2) | 174.8 (43.0) | 174.4 (45.3)# | 174.6 (44.0)†† |
| BMI at screening (kg/m2), mean (SD) | 27.5 (5.9) | 29.1 (6.6)‡‡ | 29.3 (7.1) | 29.2 (7.0)# | 29.3 (7.1)†† |
| HSDD diagnosis, n (%): | |||||
| – Primary | 57 (70) | 67 (77) | 63 (72) | 61 (72) | 124 (72) |
| – Sole | 24 (30) | 20 (23) | 24 (28) | 24 (28) | 48 (28) |
| Menses frequency regular, n (%) | 60 (74) | 63 (72) | 75 (86) | 67 (79) | 142 (83) |
| Used oral contraception within the 30 days before screening, n (%) | 10 (12) | 11 (13) | 9 (10) | 14 (17) | 23 (13) |
†
During visit 2 (prior to randomization) one patient inadvertently received a treatment kit containing BMT 1.25 mg in place of the assigned placebo. In accordance with the study protocol, this individual was considered a 1.25 mg BMT patient within the safety population.
‡
n = 97.
§
n = 196.
¶
n = 98.
#
n = 84.
††
n = 171
‡‡
n = 85.
BMT: Bremelanotide; FSAD: Female sexual arousal disorder; FSD: Female sexual dysfunction; HSDD: Hypoactive sexual desire disorder; SD: Standard deviation.