MED3000 gel: Favorable responses seen on sexual encounter questionnaire

Use of the topical MED3000 gel for erectile dysfunction appears to confer benefits for both men and their partners, according to Sexual Encounter Profile (SEP) data presented at the 2024 Sexual Medicine Society of North America Fall Scientific Meeting in Scottsdale, Arizona.¹

Faysal A. Yafi, MD, FRCSC

“MED3000 is an FDA-cleared, over-the-counter topical gel that is applied to the glans penis by the patient or partner,” according to the authors, led by Faysal A. Yafi, MD, FRCSC, associate professor of urology, director of Newport Beach Urology, director of Men's Health, and chief of Men's Health and Reconstructive Urology at the University of California, Irvine.

Previously reported data from 2 phase 3 clinical trials pointed to the safety and efficacy of MED3000. The investigators found that approximately 60% of patients across the 2 studies saw clinically meaningful improvements in International Index of Erectile Function-Erectile Function (IIEF-EF) domain scores. The gel was also found to be safe, with a low risk for local or systemic events.²

For the current study, the investigators sought to evaluate MED3000 responses in men and their partners using the SEP. They conducted a 12-week multicenter study comprised of patients from Poland, Czech Republic, Slovakia, Hungary, Georgia, Bulgaria, Latvia, Russia, and Ukraine. Instructions were given to apply MED3000 immediately before sexual intercourse. Participants “were required to have at least 4 intercourse attempts in each of the 3 4-weekly periods during treatment (weeks 1-4, 5-8, and 9-12),” wrote the authors. Both patients and partners were told to complete the SEP following each attempt at intercourse. The investigators calculated the mean percentages of patients and partners answering “yes” at baseline. They also determined mean values and changes from baseline for each 4-week period as well as the entire study.

The SEP questions were as follows:

1. Were you/Was your partner able to achieve at least some erection (some enlargement of the penis)?

2. Were you/Was your partner able to insert your/his penis into her/your vagina?

3. Did your (partner’s) erection last long enough for you to have successful intercourse?

4. Were you satisfied with the hardness of your (partner’s) erection?

5. Were you satisfied overall with the sexual experience?

A total of 250 patients were included in the study, of whom 249 were White and 1 was Asian. Mean patient age ± standard deviation was 46.8 ± 12.5 years. Duration of erectile dysfunction was 27.5 ± 36.5 months. Degree of erectile dysfunction was mild, moderate, or severe in 59.2%, 28.0%, and 12.8% of patients, respectively. Baseline IIEF-EF was 16.6 ± 4.7. All but 1 partner was White, 1 was Asian, and mean age was 43.4 ± 11.9 years.

Following use of MED3000, the investigators reported significant improvements in all 5 SEP questions in both patients and partners over the course of the 12 weeks.

“Improvements from baseline for all SEP questions for both subjects and their partners achieved statistical significance by 4 weeks (P < .001). In addition, changes from baseline for SEP questions 2 and 3 for men exceeded the minimum clinically important difference (MCID, 4 points) for these questions,” wrote the authors.

REFERENCES

1. Yafi F, Brock G, Honig S, Fisher M. Topical administration of MED3000 gel significantly improves all aspects of the sexual encounter profile for both men and their partners. Presented at: 2024 Sexual Medicine Society of North America Fall Scientific Meeting. October 17-20, 2024. Scottsdale, Arizona. Abstract 223

2. Hellstrom WJG, Brock GB, Burnett AL, Holland TJ, James KW. Efficacy and safety of MED3000, a novel topical therapy for the treatment of erectile dysfunction. Presented at: 2024 American Urological Association Annual Meeting. May 3-6, 2024. San Antonio, Texas. https://www.auajournals.org/doi/10.1097/01.JU.0001009412.04863.1b.07