- The male patient must have had a documented clinical diagnosis of erectile dysfunction
(ED) confirmed by a Sexual Health Inventory-Male (SHI-M) score of less than or equal
to 21
- a stable female partner at least 21 years of age for at least 6 months prior to
screening
- the couple must have been married or living together at the time of screening.
- The female partner must have answered "no intercourse," "sometimes," "a few times" or
"almost never" on Question 3 of the Female Partner of ED Subject Questionnaire
(FePEDS-Q)
- The male patient must not have had resting sitting and/or standing hypotension (BP
90/50mmHg) or hypertension (BP > 170/110mmHg), or significant cardiovascular disease
in the last 3 months, including cardiac failure, myocardial infarction, unstable
angina, stroke, transient ischemic attack (TIA), symptomatic or clinically significant
cardiac arrhythmias.
- Female partners must not have had significant dyspareunia or lifelong significant
sexual dysfunction based on female partner's medical and sexual history at screening.