Treatment for men with erectile dysfunction by using topical PDE-5i (Phosphodiesterase 5 Inhibitors) Mental and Behavioural Disorders
Conditions
Interventions
Erectogel, the investigational product, was administered locally. Participants applied the gel 10-15 min before intercourse for a minimum of 3 times in 2 weeks according to the following protocol: App
Monitoring: participants were asked to maintain a diary documenting the time of application and any local adverse reactions such as irritation, redness, or itching, and any systemic side effects such
adherence: participants recorded the time of intake and any systemic side effects such as headache, dizziness, or gastrointestinal disturbances in their diaries.
Randomization was performed using a
Sponsors
Iuliu Ha?ieganu University of Medicine and Pharmacy
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Males aged 18-75 years 2. Diagnosis of erectile dysfunction, confirmed by a score on the International Index of Erectile Function (IIEF)-EF<26 3. Willingness and ability to provide written informed consent, comply with the study procedures and agree with the GDPR terms 4. General good health as determined by medical history and a physical examination, ensuring participants could safely undergo both treatments
Exclusion criteria
Exclusion criteria: 1. Endocrine dysregulation 2. The presence of severe cardiovascular, hepatic, renal, or hematological conditions that could interfere with the study treatments or outcomes 3. Radiotherapy, hormone therapy for prostate cancer 4. Known hypersensitivity to any components of Erectogel or Cialis 5. Use of other medications for erectile dysfunction during the study period to prevent potential drug interactions or confounding effects like beta-blockers, 5-a-reductase inhibitors etc 6. Psychological or psychiatric disorders that could influence the study results or participant compliance 7. History of alcohol or drug abuse within the past year 8. PSA was above 4 ng/mL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Erectile function measured using the International Index of Erectile Function (IIEF) Erectile Function Domain score that specifically assesses the ability to achieve and maintain an erection sufficient for sexual intercourse at period one: beginning (day 1), 2 weeks (day 14); period two: beginning (day 1), 2 weeks (day 14) (the periods were separated by one-week wash-out) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction measured using the other IIEF Domain scores at period one: beginning (day 1), 2 weeks (day 14); period two: beginning (day 1), 2 weeks (day 14) (the periods were separated by one week wash-out) 2. Treatment preference measured using data collected by asking patients which of the two interventions they preferred at the end of the trial 3. Adverse events measured as local (e.g., skin irritation, erythema) or systemic (e.g., headache, dizziness) and documented throughout both study periods and assessed at each follow-up visit | — |
Countries
Romania
Contacts
Public ContactDragos Mihail Trifu
Outcome results
None listed