Health TrialsbyHealthPanel

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

ConditionsType 2 DiabetesType 2 Diabetes (T2DM)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18-40
SponsorUniversity of Miami

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Male sex at birth

Age 18-40 years

Diagnosis of type 2 diabetes mellitus

Diagnosis of erectile dysfunction

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Standard of Care (Tadalafil) + Eroxon® Gel GroupExperimental treatment 2 interventions
Group B: Tadalafil (Control) GroupActive comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline to Week 12

Secondary outcomes

1

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.

Time frame
Baseline to Week 12
2

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.

Time frame
Baseline to Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Sexual Medicine Society of North America Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: