PLEASURE (Pleasing Lovers, Efficacy, Arousal, Satisfaction, and Uptake Research on Eroxon)
NCT07636161 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-06-09
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.
Conditions
- Type 2 Diabetes
- Type 2 Diabetes (T2DM)
Interventions
- DEVICE
-
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.
- DRUG
-
Tadalafil is administered as standard of care at dose and schedule determined by the treating clinician.
Sponsors & Collaborators
-
Sexual Medicine Society of North America Inc.
collaborator UNKNOWN -
University of Miami
lead OTHER
Principal Investigators
-
Sonjia Kenya, E.D · University of Miami
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-30
- Primary Completion
- 2027-09-30
- Completion
- 2027-09-30
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Study to Assess the Efficacy and Safety of SK3530 on Erectile Dysfunction in Patients With Diabetes Mellitus
NCT00705861 ·Status: COMPLETED ·Phase: PHASE3
-
Daily Tadalafil in Diabetic ED Patients
NCT06962462 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
A Single Dose Randomized Five-Way Crossover Pharmacokinetics (PK) Study of Tadalafil Semi-Chewable (Gummy) Formulations in Healthy Volunteers
NCT04762082 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Safety and Efficacy of Autologous Platelet-Rich Plasma for Erectile Dysfunction.
NCT04396795 ·Status: COMPLETED ·Phase: PHASE2
-
BAY38-9456 - Pivotal Trial for Diabetes Patient
NCT00678704 ·Status: COMPLETED ·Phase: PHASE3
-
Effectiveness and Tolerability of the On-demand Use of Combined Dapoxetine With Tadalafil and Combined Dapoxetine With Lidocaine 5% Spray in Treatment of Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Alone.
NCT04703127 ·Status: UNKNOWN ·Phase: PHASE3
-
Genetic Factors of Erectile Dysfunction Degree and Response to Tadalafil Treatment in Patients With Diabetes
NCT06520839 ·Status: RECRUITING ·Phase: PHASE3
-
Efficacy Study of RX-10100 to Treat Erectile Dysfunction (ED)
NCT00693056 ·Status: COMPLETED ·Phase: PHASE2
-
Platelet-Rich Plasma With or Without Tadalafil for Erectile Dysfunction
NCT07602608 ·Status: COMPLETED ·Phase: PHASE4
-
A Study in Erectile Dysfunction
NCT00833638 ·Status: COMPLETED ·Phase: PHASE4
-
Study the Safety and Effectiveness of Tadalafil in Men With Problems Getting or Maintaining an Erection When Taken Prior to Desiring an Erection
NCT00547495 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
NCT05868668 ·Status: RECRUITING ·Phase: NA
-
A Study to Evaluate the Effects of the Libido Lift Supplement on Libido and Sexual Desire in Men
NCT07564791 ·Status: COMPLETED ·Phase: NA
-
Efficacy and Safety of Toronto Association in the Treatment of Erectile Dysfunction and Premature Ejaculation
NCT05052879 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Effect of Tadalafil Once a Day in Men With Erectile Dysfunction
NCT00836693 ·Status: COMPLETED ·Phase: PHASE3
-
The Prevalence of Erectile Dysfunction (ED) and ED Related Quality of Life of Diabetic Men
NCT00173134 ·Status: UNKNOWN
-
Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction
NCT04984993 ·Status: COMPLETED ·Phase: PHASE3
-
Treatment Response to Xiaflex for Men With Peyronie's Disease
NCT03774264 ·Status: COMPLETED
-
Serum YKL-40 Level and Platelets Indices Among Patients With Diabetic Erectile Dysfunction
NCT05446493 ·Status: COMPLETED ·Phase: PHASE4
-
Assessment of Onset, Safety & Toleration of UK-369,003 in Male Erectile Dysfunction
NCT00141349 ·Status: COMPLETED ·Phase: PHASE2
-
Phase I Study of PSD502 (Lidocaine Prilocaine Spray) Applied to the Glans Penis up to Three Times a Day for 21 Days in Healthy Male Volunteers
NCT00483990 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy of Transcutaneous Electrical Neural Stimulation and Tadalafil in Men With Erectile Dysfunction: A Randomized, Double-Blind, Bi-centric, Placebo- and Sham-Controlled Trial
NCT07574268 ·Status: COMPLETED ·Phase: PHASE4
-
A Clinical Trial to Investigate the Efficacy and Safety of Tongkat Ali Maca Plus
NCT05347329 ·Status: COMPLETED ·Phase: NA
-
Evaluation of Efficacy and Safety of Vardenafil in Patients With Erectile Dysfunction and Type 1 Diabetes
NCT00660998 ·Status: COMPLETED ·Phase: PHASE4
-
PRP Exosomes Therapy for Erectile Dysfunction
NCT07124871 ·Status: RECRUITING ·Phase: PHASE2