Efficacy and safety of a new testosterone-in-adhesive matrix patch applied every 2 days for 1 year to hypogonadal men.
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.
Raynaud
Jean-Pierre
JP
Université Pierre et Marie Curie, Paris, France. jeanpierre@raynaud.ws
Legros
Jean-Jacques
JJ
Rollet
Jacques
J
Augès
Marie
M
Bunouf
Pierre
P
Sournac
Michel
M
Fiet
Jean
J
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
D000269:Adhesives; D003692:Delayed-Action Preparations; D013196:Dihydrotestosterone; D013739:Testosterone; D000735:Androstenedione; C004648:testosterone enanthate; D017430:Prostate-Specific Antigen