Efficacy of oral disintegrating strip sildenafil for the treatment of erectile dysfunction: A prospective, Randomized trial

Phase 3

• Conditions: Erectile dysfunction; Men' s health; PDE- 5 inhibitor

• Registration Number: TCTR20181121002
• Lead Sponsor: Goverment pharmaceutical organization (GPO)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-21
• Study Completion: 2020-12-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: Male
• Target Recruitment: 120

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

•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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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