title: Efficacy and safety of a new testosterone-in-adhesive matrix patch applied every 2 days for 1 year to hypogonadal men.
abstract: OBJECTIVE
  To study long-term efficacy and safety of a testosterone-in-adhesive matrix patch, delivering 4.8 mg of testosterone daily.
  
  
  METHODS
  Randomized, open label, multicenter 1-year study. 224 hypogonadal patients were included. 188 received 2 patches of 60 cm2 every 48 h and 36 patients had IM testosterone enanthate injection every 3 weeks. T, bioavailable T (BT), DHT, E2, LH, FSH and SHBG and clinical symptom scores (AMS and MSF-4) were assessed at 3, 6 and 12 months.
  
  
  RESULTS
  In the patch group, T serum levels were above 3 ng/mL in 85% of patients and remained stable over time. BT, DHT and E2 levels were restored within physiological range. BT/T ratio varied from 20 to 70%. In the IM group, the percentages of "normalized" patients appeared to be lower, although the two groups cannot be adequately compared due to the kinetic profile of T following IM administration, resulting in greater variations of serum T levels, blood samplings occurring randomly at time of peak, trough, or in between. A significant correlation was found between T, BT and the MSF-4 changes. BT levels were significantly related to total AMS score. PSA values showed a mean (S.D.) increase of 0.13 (0.38), 0.23 (0.79) and 0.30 (1.47)ng/mL at weeks 14, 27 and 53, respectively. The patch was well tolerated with no negative impact either on lipid profile, or red blood cells. Administration site reactions occurred in 35 patients (18.8%). Adhesiveness was good (>or=75%) in >90% patients over the 1 year application period.
  
  
  CONCLUSIONS
  Two 60 cm2 patches, allowed constant physiological levels of sexual hormones over time. This new patch was well tolerated, easy to use, well accepted by the patients and displayed a very good adhesiveness. Clinical efficacy was more related to BT than to T.
authors.affiliation: Université Pierre et Marie Curie, Paris, France. jeanpierre@raynaud.ws
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Raynaud
authors.forename: Jean-Jacques
authors.initials: JJ
authors.lastname: Legros
authors.forename: Jacques
authors.initials: J
authors.lastname: Rollet
authors.forename: Marie
authors.initials: M
authors.lastname: Augès
authors.forename: Pierre
authors.initials: P
authors.lastname: Bunouf
authors.forename: Michel
authors.initials: M
authors.lastname: Sournac
authors.forename: Jean
authors.initials: J
authors.lastname: Fiet
mesh_terms: D000268:Adhesiveness; D000269:Adhesives; D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000735:Androstenedione / Q000097:blood; D001682:Biological Availability; D003692:Delayed-Action Preparations; D013196:Dihydrotestosterone / Q000097:blood; D004334:Drug Administration Schedule; D016503:Drug Delivery Systems; D004361:Drug Tolerance; D006801:Humans; D007006:Hypogonadism / Q000097:blood / Q000188:drug therapy*; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000097:blood; D012449:Safety; D013739:Testosterone / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives / Q000097:blood; D013997:Time Factors
chemical_list: D000269:Adhesives; D003692:Delayed-Action Preparations; D013196:Dihydrotestosterone; D013739:Testosterone; D000735:Androstenedione; C004648:testosterone enanthate; D017430:Prostate-Specific Antigen