The effects of daily low dose PDE5 inhibitor on cerebral perfusion and cognition in patients with erectile dysfunction

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0003306

Enrollment

Registered

2018-10-31

Start date

2017-08-24

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Male patients aged 50 to 75 years with at least three months of ED (International Index of Erectile Function [IIEF]-5 score &lt

21) and mild cognitive impairment (Montreal Cognitive Assessment [MoCA] score = 22) were included in the study. The subjects were prescribed a low-dose PDE5 inhibitor (tadalafil 5 mg) to be taken once

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: (1) Male patients aged 50 years to 75 years (2) Patients with at least three months of ED (3) Regular sex with one sex partner (4) International Index of Erectile Function [IIEF]-5 score < 21 (5) Mild cognitive impairment (Montreal Cognitive Assessment [MoCA] score = 22) (6) Patients who understand the purpose of this clinical trial and decide to participate voluntarily by written consent

Exclusion criteria

Exclusion criteria: (1) Serious cerebrovascular, cardiovascular conditions or pigmented retinitis (2) Those with a contraindication for using PDE5 inhibitor (3) Patients currently taking tricyclic antidepressants, monoamine oxidase inhibitors, or selective serotonin reuptake inhibitors (4) Patients currently taking nitrate or nitric oxide donors (5) Uncontrolled hypotension (Less than 90/50mmHg) (6) Uncontrolled hypertension (More than 170/100mmHg) (7) Uncontrolled arrhythmia (8) History of renal or hepatic abnormalities (9) Use of cytochrome P450 3A4 inhibitors and drugs for the treatment of dementia (e.g., donepezil, rivastigmine, galantamine, or memantine) (10) Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose uptake disorder

Design outcomes

Primary

Measure	Time frame
Changes in regional cerebral blood flow on SPECT	—

Secondary

Measure	Time frame
Changes in cognitive function and BDNF level	—

Countries

Korea, Republic of

Contacts

Public ContactJin Bong Choi

The Catholic University of Korea, Bucheon St. Mary's Hospital

c-sparrow@hanmail.net+82-32-340-7538

Outcome results