Table 3.
Efficacy outcomes: mean (standard deviation) changes from baseline† to end of study (modified intent-to-treat population).
| Outcome 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 (events per 28 days, from FSEP-R Q10) | + 0.2 (2.3) | + 0.6 (3.6)§ | +0.7 (1.8) | + 0.8 (2.9)*¶ | + 0.7 (2.4)*# | ||
| – FSDS-DAO arousal score | −0.5 (1.3) | −0.5 (1.2) | −0.5 (0.9) | −0.9 (1.1)* | −0.7 (1.0) | ||
| – FSDS-DAO desire score | −0.6 (1.3) | −0.5 (1.1) | −0.7 (1.0) | −1.1 (1.2)** | −0.9 (1.1)* | ||
| – FSFI total score | + 1.9 (5.9) | +1.5 (6.9) | +2.8 (5.7)* | + 4.4 (5.6)** | +3.6 (5.7)** | ||
| – FSFI arousal score | +0.5 (1.4) | +0.4 (1.5) | +0.7 (1.1) | + 1.1 (1.2)** | +0.9 (1.1) | ||
| – FSFI desire score | + 0.4 (1.1) | +0.3 (1.1) | +0.6 (0.8) | + 1.0 (1.0)** | +0.8 (0.9)** | ||
| – FSDS-DAO total score | −6.8 (13.6) | −7.4 (13.5) | −9.2 (10.8) | −13.1 (12.9)*** | −11.1 (12.0)** | ||
| Exploratory measures: | |||||||
| – Level of sexual arousal (FSEP-R Q6) | −0.1 (0.9) | + 0.1 (1.0)§ | + 0.2 (0.9)* | + 0.4 (0.8)*** | + 0.3 (0.9)***# | ||
| – Satisfaction with arousal (FSEP-R Q7) | 0.0 (1.0) | + 0.1 (1.0)§ | + 0.5 (1.0)* | + 0.6 (0.8)***¶ | + 0.5 (0.9)***# | ||
| – Level of sexual desire (FSEP-R Q3) | 0.0 (0.9) | 0.0 (0.9)§ | +0.3 (0.8)* | + 0.4 (0.8)***¶ | + 0.4 (0.8)***# | ||
| – Satisfaction with desire (FSEP-R Q4) | +0.1 (1.0) | + 0.3 (0.9)§ | + 0.4 (0.8)* | +0.6 (0.8)**¶ | + 0.5 (0.8)**# | ||
| Patients with primarily or solely HSDD†† | |||||||
| n | 76 | 76 | 66 | 63 | 129 | ||
| Exploratory measures: | |||||||
| – SSEs (events per 28 days, from FSEP-R Q10) | +0.2 (2.2) | + 0.8 (3.60)‡‡ | +0.7 (1.9) | + 0.7 (2.8)*§§ | +0.7 (2.3)*¶¶ | ||
| – FSFI total score | + 1.6 (5.9) | +1.5 (7.2) | +3.1 (5.5)** | +4.2 (5.4)** | +3.7 (5.5)*** | ||
| – FSFI desire score | + 0.4 (1.1) | +0.3 (1.1) | +0.6 (0.8) | + 1.0 (0.9) | +0.8 (0.9) | ||
| – FSDS-DAO total score | −6.6 (14.1) | −8.0 (13.4) | −9.6 (11.2)* | −12.7 (12.6)** | −11.1 (12.0)** | ||
| – FSDS-DAO desire score | 0.6 (1.2) | −0.5 (1.0) | −0.7 (1.0) | −1.0 (1.1) | −0.9 (1.1) | ||
Van Elteren test stratified by diagnosis.
*
p < 0.05 versus placebo.
**
p < 0.01 versus placebo.
***
p < 0.001 versus placebo.
†
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.
††
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; SSEs: Satisfying sexual events.