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
University of Miami
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.
Eligibility
- Age range
- 18–40 years
- Sex
- Male
- 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
Interventions
- DeviceEroxon®
Participants will receive a 12-week supply of Eroxon® and will be instructed to apply the gel prior to each sexual encounter as directed at enrollment.
- Drugtadalafil
Tadalafil is administered as standard of care at dose and schedule determined by the treating clinician.
Location
- Don Soffer Clinical Research BuildingMiami, Florida