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. 2021 Sep 24;5:100. doi: 10.1186/s41687-021-00359-1

Table 5.

FSDS-DAO versus specified PRO measures (evaluable mITT sample)

Comparator Spearman’s rank correlation coefficient
End of baseline placebo self-dosing (N = 323) End of double-blind study-drug use (N = 309)
FSFI total − 0.65b − 0.66b
FSFI desire − 0.58b − 0.63b
FSFI arousal − 0.59b − 0.64b
FSFI lubrication − 0.44b − 0.41b
FSFI orgasm − 0.43b − 0.55b
FSFI satisfaction − 0.67b − 0.66b
FSFI pain − 0.17c − 0.22b
GAQ Q1 (satisfaction with arousal) − 0.46b − 0.57b
GAQ Q2 (satisfaction with desire) − 0.45b − 0.56b
GAQ Q3 (benefit from study drug) − 0.41b − 0.54b
WITS-9 total − 0.55b − 0.64b
Number of SSEs per montha − 0.42b − 0.32b

FSDS-DAO = Female Sexual Distress Scale-Desire/Arousal/Orgasm; FSFI = Female Sexual Function Index; GAQ = General Assessment Questionnaire; mITT = modified intent-to-treat; PRO = patient-reported outcome; Q = Question; SSEs = satisfying sexual events; WITS = Women's Inventory of Treatment Satisfaction

aN = 314 at end of baseline and 267 at end of double-blind treatment

bP < 0.001

cP < 0.01