Type 2 DiabetesPhase 4NCT07636161
PLEASURE (Pleasing Lovers, Efficacy, Arousal, Satisfaction, and Uptake Research on Eroxon)
A Phase 4 study testing Eroxon® and tadalafil in people with Type 2 Diabetes and Type 2 Diabetes (T2DM), run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Type 2 Diabetes, Type 2 Diabetes (T2DM)
- What is being tested?
- Eroxon® and tadalafil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Sep 2027
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Don Soffer Clinical Research Building
Miami, Florida, 33136
About this study
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
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.
- Conditions
- Type 2 Diabetes, Type 2 Diabetes (T2DM)
- Being tested
- Eroxon®, tadalafil
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (Tadalafil) + Eroxon® Gel Group | Experimental | Participants assigned to this arm will continue to use tadalafil as prescribed per standard of care treatment and will also be instructed to use Eroxon® gel prior to each sexual encounter throughout the 12-week study period. Receives: Device: Eroxon®; Drug: tadalafil |
| Tadalafil (Control) Group | Active comparator | Participants assigned to this arm will continue their standard-of-care treatment with tadalafil as prescribed. No study-specific changes will be made to their routine clinical management. Receives: Drug: tadalafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 12
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Why it stopped: The sponsor has communicated that they may no longer fund this research study. Pending final confirmation if the study will be closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Sexual Medicine Society of North America Inc.
- Responsible party
- Principal investigator, Sonjia Kenya, University of Miami
- Investigators
- Sonjia Kenya, E.D, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636161
- Sponsor's protocol ID
- 20260268
- Status last verified
- Sep 2026
- First submitted
- 3 Jun 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07636161
- Acronym / sponsor ID
- 20260268
- Conditions
- Type 2 Diabetes, Type 2 Diabetes (T2DM)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The sponsor has communicated that they may no longer fund this research study. Pending final confirmation if the study will be closed.
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Sexual Medicine Society of North America Inc.
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (Tadalafil) + Eroxon® Gel Group | Experimental | Device: Eroxon®, Drug: tadalafilParticipants assigned to this arm will continue to use tadalafil as prescribed per standard of care treatment and will also be instructed to use Eroxon® gel prior to each sexual encounter throughout the 12-week study period. |
| Tadalafil (Control) Group | Active comparator | Drug: tadalafilParticipants assigned to this arm will continue their standard-of-care treatment with tadalafil as prescribed. No study-specific changes will be made to their routine clinical management. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male sex at birth
- Age 18-40 years
- Diagnosis of type 2 diabetes mellitus
- Diagnosis of erectile dysfunction
- Currently prescribed tadalafil
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Standard of Care (Tadalafil) + Eroxon® Gel Group |
| tadalafilTadalafil is administered as standard of care at dose and schedule determined by the treating clinician. | Drug | Standard of Care (Tadalafil) + Eroxon® Gel Group, Tadalafil (Control) Group |
Primary outcome
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.
2 secondary outcomes
Change in Patient Adherence
Time frame: Baseline to Week 12
Change in Partner Acceptability
Time frame: Baseline to Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonjia Kenya, E.D principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eroxon® and tadalafil in people with Type 2 Diabetes and Type 2 Diabetes (T2DM), run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Erectile Functioning (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.