Efficacy of Oral Disintegrating Strip Sildenafil for the Treatment of Erectile Dysfunction: A Prospective, Randomized Trial
- Conditions
- Erectile dysfunction
- Registration Number
- TCTR20180216002
- Lead Sponsor
- The Government Pharmaceutical Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- Male
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method IIEF-5 and EHS scores Screening, Enrollment, 4 weeks and 8 weeks post dose, and end of study Questionaires
- Secondary Outcome Measures
Name Time Method Safety Screening, Enrollment, 4 weeks and 8 weeks post dose, and end of study Vital signs and laboratory measurements