PLEASURE (Pleasing Lovers, Efficacy, Arousal, Satisfaction, and Uptake Research on Eroxon)

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

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 Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes; Type 2 Diabetes (T2DM)
• Intervention / Treatment: Device: Eroxon®; Drug: tadalafil

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ashley Gray; Phone Number: 786-909-3719; Email: ajg2940@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Don Soffer Clinical Research Building
      • Contact: Ashley Gray; Phone Number: 786-909-3719; Email: ajg2940@med.miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard of Care (Tadalafil) + Eroxon® Gel Group; Participants assigned to this arm will continue to use tadalafil as prescribed per standard of care treatment and will also be instructed to use Eroxon® gel prior to each sexual encounter throughout the 12-week study period.	Device: Eroxon®; 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.; Drug: tadalafil; Tadalafil is administered as standard of care at dose and schedule determined by the treating clinician.
Active Comparator: Tadalafil (Control) Group; Participants assigned to this arm will continue their standard-of-care treatment with tadalafil as prescribed. No study-specific changes will be made to their routine clinical management.	Drug: tadalafil; Tadalafil is administered as standard of care at dose and schedule determined by the treating clinician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Erectile Functioning	Erectile function assessed using the International Index of Erectile Function-5 (IIEF-5), a validated 5-item patient-reported questionnaire. Total scores range from 5 to 25, with higher scores indicating better erectile function.	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Adherence	Patient adherence assessed using the Medication Adherence Report Scale-5 (MARS-5), a validated five-item self-report questionnaire measuring both intentional and unintentional non-adherence. Each item is scored on a 5-point Likert scale, with total scores ranging from 5 to 25, and higher scores indicating better adherence.	Baseline to Week 12
Change in Partner Acceptability	Partner acceptability assessed using the Sexual Life (ISL) scale, a validated 11-item questionnaire evaluating satisfaction and acceptability related to sexual activity. Each item is scored on a 5-point Likert scale, with total scores ranging from 5 to 25, with higher scores indicating greater partner satisfaction and acceptability.	Baseline to Week 12

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Sexual Medicine Society of North America Inc.
• Investigators: Principal Investigator: Sonjia Kenya, E.D, University of Miami

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Indole Alkaloids; Heterocyclic Compounds, 3-Ring; Carbolines; Tadalafil
• Other Study ID Numbers: 20260268

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No