Daily Avanafil for Erectile Dysfunction

University of Alexandria

Status and phase: Completed; Phase 4

Conditions: Erectile Dysfunction

Treatments: Drug: Placebo oral tablet; Drug: Avanafil 50 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT04374994

0105643

Details and patient eligibility

About

In this study, the investigators tried to study the effect of daily avanafil on the serum level of endothelial function markers, as well as its impact on the erectile function in males with erectile and endothelial dysfunction by comparing the results with controls who received placebo.

Full description

Avanafil is a highly selective and potent oral phosphodiesterase type 5 inhibitor (PDE5-I) . However, its impact on the soluble markers of endothelial function has not been investigated yet. This study was conducted to assess the effect of daily avanafil on the erectile function and endothelial markers' serum level. In this work we recruited males with erectile dysfunction and other diseases commonly associated with endothelial dysfunction. The investigators randomly treated patients with daily oral avanafil and the other patients with placebo. The investigators measured the International Index of Erectile Function -5 score (IIEF- 5) and the serum levels of markers of endothelial function at baseline and treatment.

Enrollment: 70 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men with clinical diagnosis of erectile dysfunction of any severity.
• Should be associated with systemic disorders indicative of endothelial dysfunction

Exclusion criteria

• Erectile dysfunction due to psychogenic causes, hypogonadism, or spinal cord injury.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

70 participants in 2 patient groups, including a placebo group

intervention group

Active Comparator group

Description:

Males with sexual dysfunction who received daily avanafil tablets (50mg) for four weeks

Treatment:

Drug: Avanafil 50 MG

control group

Placebo Comparator group

Description:

Males with sexual dysfunction who received daily placebo tablets for four weeks

Treatment:

Drug: Placebo oral tablet