Table 2.
Female sexual dysfunction measures: mean (standard deviation) baseline† values (modified intent-to-treat population population).
| Measure | Placebo group | BMT groups |
|||
|---|---|---|---|---|---|
| 0.75 mg | 1.25 mg | 1.75 mg | 1.25/1.75 mg pooled | ||
| All patients | |||||
| n | 91 | 87 | 75 | 74 | 149 |
| Prespecified measures‡: | |||||
| – SSEs during the 28 days before | 1.7 (1.9) | 1.9 (2.1)§ | 1.5 (1.6) | 1.8 (2.6)¶ | 1.6 (2.1)# |
| randomization (FSEP-R Q10) | |||||
| – FSDS-DAO arousal score†† | 2.3 (1.1) | 2.1 (1.0) | 2.3 (1.0) | 2.4 (0.9) | 2.3 (1.0) |
| – FSDS-DAO desire score†† | 2.6 (1.0) | 2.4 (0.9) | 2.5 (1.0) | 2.7 (0.9) | 2.6 (1.0) |
| – FSFI total score‡‡ | 21.9 (5.9) | 22.8 (5.4) | 21.5 (5.4) | 21.7 (5.0) | 21.6 (5.2) |
| – FSFI arousal score§§ | 3.0 (1.3) | 3.2 (1.2) | 2.9 (1.2) | 2.9 (1.1) | 2.9 (1.3) |
| – FSFI desire score§§ | 2.4 (1.0) | 2.6 (1.1) | 2.5 (0.9) | 2.4 (1.0) | 2.5 (0.9) |
| – FSDS-DAO total score¶¶ | 32.1 (12.8) | 30.5 (12.4) | 32.7 (13.8) | 33.3 (12.7) | 33.0 (13.2) |
| Exploratory measures: | |||||
| – Level of sexual arousal (FSEP-R Q6)## | 1.4 (0.7) | 1.4 (0.7)§ | 1.2 (0.7) | 1.3 (0.7)¶ | 1.3 (0.7)# |
| – Satisfaction with arousal (FSEP-R Q7)††† | 1.1 (0.8) | 1.2 (0.8)§ | 1.0 (0.7) | 1.0 (0.8)¶ | 1.0 (0.7)# |
| – Level of sexual desire (FSEP-R Q3)## | 1.1 (0.7) | 1.2 (0.7)§ | 1.1 (0.7) | 1.0 (0.7)¶ | 1.1 (0.7)# |
| – Satisfaction with desire (FSEP-R Q4)††† | 0.9 (0.8) | 0.9 (0.8)§ | 0.8 (0.8) | 0.8 (0.8)¶ | 0.8 (0.8)# |
| Patients with primarily or solely HSDD‡‡‡ | |||||
| n | 76 | 76 | 66 | 63 | 129 |
| Exploratory measures: | |||||
| – SSEs during the 28 days before randomization (FSEP-R Q10) | 1.6 (1.8) | 1.8 (2.0)§§§ | 1.5 (1.4) | 1.9 (2.7)¶¶¶ | 1.6 (2.1)### |
| – FSFI total score‡‡ | 22.2 (6.1) | 22.8 (5.6) | 21.6 (5.5) | 21.5 (4.9) | 21.6 (5.2) |
| – FSFI desire score§§ | 2.4 (1.0) | 2.6 (1.1) | 2.5 (0.9) | 2.3 (0.9) | 2.4 (0.9) |
| – FSDS-DAO total score¶¶ | 32.9 (13.0) | 31.1 (12.4) | 32.5 (14.0) | 33.7 (12.3) | 33.1 (13.1) |
| – FSDS-DAO desire score†† | 2.6 (1.0) | 2.5 (0.9) | 2.5 (1.0) | 2.7 (0.95) | 2.6 (1.0) |
Each patient's single-blind placebo month.
Listed in the order prespecified by the study protocol for hierarchical statistical testing.
n = 85.
n = 73.
n = 148.
From 0 (best possible score) to 4 (worst possible score).
From 2 (worst possible total score) to 36 (best possible total score).
From 0 (worst possible score) to 6 (best possible score).
From 0 (best possible total score) to 60 (worst possible total score).
From 0 (no desire or arousal) to 3 (high desire or arousal).
From 0 (not at all satisfied) to 3 (completely satisfied).
HSDD with or without decreased arousal.
n = 74.
n = 62.
n = 128.
BMT: Bremelanotide; FSDS-DAO: Female sexual distress scale-desire/arousal/orgasm; FSEP-R: Female sexual encounter profile-revised; FSFI: Female sexual function index; HSDD: Hypoactive sexual desire disorder; SSE: Satisfying sexual event.