Erectile dysfunction
Conditions
Interventions
Two strips of Sildenafil Oral Disintegrating Strips 50 mg,One tablet of Sildenafil 100 mg Tablets
Experimental Drug,Active Comparator Drug
Sildenafil Oral Disintegrating Strips,Sildenafil 100 mg Tablets
Sponsors
The Government Pharmaceutical Organization
The Government Pharmaceutical Organization
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients with erectile dysfunction condition who are ≥ 18 years old. - Sexual intercourse is failed for ≥ 50% of total sexual activities - Erectile dysfunction for ≥ 3 months - Have only one heterosexual partner and have sexual intercourse at least 2 times per month - Agree to participate in this study and sign the informed consent form
Exclusion criteria
Exclusion criteria: - Any history of contraindication or hypersensitivity to PDE5 inhibitors - Any history of insensitive to PDE5 inhibitor treatment - Erectile dysfunction due to spinal cord injury - History of radical prostatectomy - Having untreated blood glucose > 270 mg/dl - Having untreated hypogonadism - PSA > 4 ng/dl - Presence of abnormal condition in cardiovascular, hepatic, and renal systems which might be compromised by PDE5 inhibitor treatment - Presence of orthostatic hypotension or uncontrolled blood pressure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IIEF-5 and EHS scores Screening, Enrollment, 4 weeks and 8 weeks post dose, and end of study Questionaires | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Screening, Enrollment, 4 weeks and 8 weeks post dose, and end of study Vital signs and laboratory measurements | — |
Countries
Thailand
Contacts
Public ContactWisoot Khongcharoensombat
Faculty of Medicine, Ramathibodi Hospital
Outcome results
None listed