PLEASURE (Pleasing Lovers, Efficacy, Arousal, Satisfaction, and Uptake Research on Eroxon)
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 type-2-diabetes
Started Sep 2026
Shorter than P25 for phase_4 type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2026
CompletedFirst Posted
Study publicly available on registry
June 9, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
Study Completion
Last participant's last visit for all outcomes
September 1, 2027
June 9, 2026
May 1, 2026
1 year
June 3, 2026
June 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change in Patient Adherence
Baseline to Week 12
Change in Partner Acceptability
Baseline to Week 12
Study Arms (2)
Standard of Care (Tadalafil) + Eroxon® Gel Group
EXPERIMENTALParticipants 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.
Tadalafil (Control) Group
ACTIVE COMPARATORParticipants 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.
Interventions
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.
Tadalafil is administered as standard of care at dose and schedule determined by the treating clinician.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- Sexual Medicine Society of North America Inc.collaborator
Study Sites (1)
Don Soffer Clinical Research Building
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sonjia Kenya, E.D
University of Miami
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Professional Practice
Study Record Dates
First Submitted
June 3, 2026
First Posted
June 9, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
June 9, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share