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Not yet recruiting NCT07636161

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

Phase IV Interventional Type 2 Diabetes Type 2 Diabetes (T2DM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Eroxon®, tadalafil.
Who it may be relevant to
Registry conditions: Type 2 Diabetes, Type 2 Diabetes (T2DM). Basic parameters: 18 years — 40 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Change in Erectile Functioning [Time frame: Baseline to Week 12]
Secondary outcome measures (2)
  • Change in Patient Adherence [Time frame: Baseline to Week 12]
  • Change in Partner Acceptability [Time frame: Baseline to Week 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Don Soffer Clinical Research Building — Miami

Identifiers

NCT: NCT07636161 · 20260268

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗