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

Phase 4Not Yet RecruitingNCT07636161

University of Miami30 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Type 2 Diabetes (T2DM)

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.

tadalafilDRUG

Tadalafil is administered as standard of care at dose and schedule determined by the treating clinician.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Don Soffer Clinical Research Building

Miami, Florida, United States

Outcomes

Primary Outcomes

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

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

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

Central Contacts

Ashley Gray

CONTACT

786-909-3719 ajg2940@med.miami.edu

Data from ClinicalTrials.gov

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