Type 2 Diabetes, Type 2 Diabetes (T2DM)
Conditions
Brief summary
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
DEVICEEroxon®
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.
DRUGtadalafil
Tadalafil is administered as standard of care at dose and schedule determined by the treating clinician.
Sponsors
University of Miami
Sexual Medicine Society of North America Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Erectile Functioning | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Adherence | 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. |
| Change in Partner Acceptability | 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. |
Countries
United States
Contacts
CONTACTAshley Gray
PRINCIPAL_INVESTIGATORSonjia Kenya, E.D
University of Miami
Outcome results
None listed