Table 4.

Outcome measures.

Primary Outcome Measures
Tampon test	Measures pain with tampon insertion and removal on 0–10 NRSa
Secondary outcome measures
Coital pain	Pain experienced with sexual intercourse in the last 24 hours on a 10-10 NRSa
24-hours Pain	Average vulvodynia pain over last 24 hours on 0–10 NRSa
Psychometric measures
BPI Interference Scaleb	Assesses degree to which pain interferes with physical and emotional functioning and sleep
HADSc	Measures dimensional and categorical aspects of anxiety and depression
PGICd	Measures improvement of symptoms with treatment
FSFIe	Measures sexual function including desire, arousal, lubrication, orgasm, satisfaction and pain subscales
Locke-Wallace Marital Adjustment Test	Measures degree of happiness in relationship, common interests and beliefs and conflict management
SF-36f	Measures quality of life
Leserman Sexual and Physical Abuse Questionnaire	Measures history of physical and sexual abuse
Biological measures
Capsaicin skin sensitivity test	Measures central sensitization, a dimension of neuropathic pain
Heart rate variability (HRV)	Measures autonomic nervous system dysregulation
Vaginal algometer	Measures pressure pain thresholds in pelvic floor muscles
Tender point tenderness	Measures pain to pressure when applied to specific areas in the musculoskeletal system
Algesiometer	Measures vulvar mechanical hyperalgesia
Safety end points
Medical history, physical exam, Pelvic examination	Assess for any findings that may increase risk for adverse events
Clinical laboratory testing	Complete blood cell count + differential, comprehensive metabolic panel, urine pregnancy test, urinalysis, Affirm Testg
Serum creatine phosphokinase (CK)	If signs or symptoms of rhabomyolysis occur
Serious adverse events (SAEs)	Death, life-threatening drug experience, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity or congenital anomaly/birth defect

^aNRS: Numeric Rating Scale

^bBPI: Brief Pain Inventory Interference Scale

^cHADS: Hamilton Anxiety and Depression Rating Scale

^dPGIC: Patient Global Impression Change Scale

^eFSFI: Female Sexual Function Index

^fSF-36: MOS 36-item short-form health survey

^gAffirm: VPIII microbial identification test for vaginal infection