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NCT Number: NCT07636161

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes (T2DM)

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Erectile Functioning

    Time frame: Baseline to Week 12

    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.

Secondary outcomes

  1. Change in Patient Adherence

    Time frame: Baseline to Week 12

    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.

  2. Change in Partner Acceptability

    Time frame: Baseline to Week 12

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley Gray

CONTACT

[email protected]

786-909-3719

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Sexual Medicine Society of North America Inc.

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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