Erectile dysfunction Erectile dysfunction Men'
Conditions
Interventions
Hart-
S (Sildenafil)
Dosage form: oral disintegrating strip
Dosage: 50 mg/ strip
Instruction: participant using 2 strips before having sexual activity which once a week as minimum frequency for 8 weeks dura
Experimental Drug,Active Comparator Drug
strip,tablet
Sponsors
Goverment pharmaceutical organization (GPO)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria • 18 years or older ED patients, defined as erection hardness score (EHS)≤ 3 or International index of erectile function 5 (IIEF-5)≤ 21 • Had a 50% or greater failure rate in maintaining erection long enough to achieve successful intercourse • ED symptoms persist at least 3 months • Patients were required to have been in a monogamous, heterosexual relationship for 3 months or longer and to agree to make at least 2 attempts of intercourse per month. (Patients will receive medication maximum 1 tablet/week or 1 strip/week during crossover period, total 8 tablets, 8 strips/patient)
Exclusion criteria
Exclusion criteria: Exclusion criteria • Patients who have contraindications of PDE5 inhibitors (nitrate use, pre-existing intermediate to high cardiac risk factors) or an allergy or hypersensitivity to a PDE5 inhibitor or a history of consistent treatment failure or dose-limiting AEs during therapy with other PDE5 inhibitors. • ED that resulted from spinal cord injury or radical prostatectomy, blood glucose level greater than 270 mg/dL, and untreated hypogonadism. • Patients who have PSA > 4 ng/dl, clinically significant cardiac, hepatic, or renal disease; orthostatic hypotension; or uncontrolled hypertension or hypotension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of oral disintegrating strip sildenafil for the treatment of erectile dysfunction 4 and 8 weeks after initiation of oral disintegrating strip and tablet form EHS and IIEF-5 questionaire | — |
Secondary
| Measure | Time frame |
|---|---|
| time to erection,satisfaction, side effect of oral disintegrating strip sildenafil 4,8 and 12 weeks after initiation of oral disintegrating strip and tablet form questionaire | — |
Countries
Thailand
Contacts
Public ContactPremsant Sangkum
Ramathibodhi hospital, Mahidol Unversity
Outcome results
None listed