NCT07636161Not yet recruitingPhase 4
PLEASURE (Pleasing Lovers, Efficacy, Arousal, Satisfaction, and Uptake Research on Eroxon): A Pilot Randomized Trial of Eroxon® Gel as an Adjunct to Tadalafil in Young Men With Diabetes-Associated Erectile Dysfunction
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- University of Miami
- Enrollment
- 30
- Locations
- 1
Study Overview
Brief Summary
The purpose of this research study is to look at whether Eroxon® gel when used together with tadalafil, may help improve erectile function in men ages 18 to 40 who have type 2 diabetes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male sex at birth
- •Age 18-40 years
- •Diagnosis of type 2 diabetes mellitus
- •Diagnosis of erectile dysfunction
- •Currently prescribed tadalafil
- •Have a sexual partner willing to complete a survey
- •Ability to provide informed consent
Exclusion Criteria
- •Type 1 diabetes mellitus
- •Severe psychiatric illness that would impair participation
- •Use of nitrates or contraindications to sexual activity
- •Known allergy to Eroxon® gel components
- •Participation in another interventional sexual health study
Investigators
Sonjia Kenya
Professor of Professional Practice
University of Miami
Study Sites (1)
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