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

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07636161
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Eroxon® — DEVICE
    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 — DRUG
    Tadalafil is administered as standard of care at dose and schedule determined by the treating clinician.

Study Details

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.

Key Dates

Start date
Sep 30, 2026
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Change in Erectile Functioning [ Time Frame: Baseline to Week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Don Soffer Clinical Research BuildingMiamiFlorida33136
Ashley Gray
[email protected]
786-909-3719

Find similar trials in Miami, FL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Don Soffer Clinical Research Building· Miami, FL

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