(223) TOPICAL ADMINISTRATION OF MED3000 GEL SIGNIFICANTLY IMPROVES ALL ASPECTS OF THE SEXUAL ENCOUNTER PROFILE FOR BOTH MEN AND THEIR PARTNERS
Notice bibliographique
Résumé
Abstract Introduction There is a significant unmet need for an erectile dysfunction (ED) treatment that is efficacious and well-tolerated, works quickly, and facilitates intimacy. MED3000 is a, FDA-cleared, over-the-counter topical gel that is applied to the glans penis by the patient or partner. Objective To assess responses to MED3000 in men and their partners using the Sexual Encounter Profile (SEP). Methods MED3000 was tested in a 12-week, multicenter study that included patients with a clinical diagnosis of ED for >3 months according to the NIH Consensus Statement. Subjects or their partners were instructed to apply MED3000 immediately prior to sexual intercourse and were required to have at least 4 intercourse attempts in each of the three 4-weekly periods during treatment (weeks 1-4, 5-8, and 9-12). Subjects and their partners were instructed to complete the SEP after each sexual intercourse attempt. Mean percentages of subjects and partners answering yes at baseline and mean values and changes from baseline for each 4-week period and for the entire 12-week study were determined. Baseline results and those from the entire 12-week study were compared with paired t-tests. With Bonferroni correction, p < 0.005 was the accepted value for statistical significance. Efficacy analyses were conducted using all subjects who made use of the treatment at least once. Results A total of 250 subjects (mean age ± standard deviation (SD) = 46.8 ± 12.5 years, duration of ED = 27.5 ± 36.5 months, 59.2%, 28.0%, and 12.8% with mild, moderate, or severe ED, respectively) were treated with MED3000 and all were included in the analysis. For partners, 249 were White and 1 was Asian and the mean age was 43.4 ± 11.9 years. Use of MED3000 resulted in significant improvements in all 5 SEP questions for both subjects and partners over 12 weeks (Table 1). Improvements from baseline for all SEP Questions for both subjects and their partners achieved statistical significance by 4 weeks (P < 0.001). 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. Conclusions This multicenter study shows that use of MED3000 resulted in statistically significant improvement from baseline for all SEP questions for both subjects and their partners, including achievement of erections, insertion of the penis, successful intercourse, and satisfaction with hardness of erections and overall sexual experience. Disclosure Yes, this is sponsored by industry/sponsor: Haleon. Clarification: Industry funding only - investigator initiated and executed study.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,000 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,006 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».