Hypogonadal men found to have greater clinical improvement with transdermal delivery.
TORONTO—Smooth and prolonged release of testosterone by transdermal delivery (Testopatch) translates into greater clinical improvement in hypogonadal men compared with oral testosterone, French researchers say.
“We found that the patch is very easy to use and it sticks very well. Men can wear it for two days and there are no problems with men exercising or having it come off,” said investigator Jean-Pierre Raynaud, DSc, an endocrinologist at the University of Pierre et Marie Curie in Paris. “The patch is very thin and transparent, and you get stable doses delivered to the patient for 48 hours.”
Dr. Raynaud and his colleagues, who reported their results here at the 89th annual meeting of The Endocrine Society, examined the effect of the two testosterone delivery systems in 44 hypogonadal men (mean age 49 years) who participated in a randomized, open-label, crossover study. The study involved two consecutive periods of treatment for 22 days each, separated by a 14-day washout period.
At inclusion, all the men had testosterone levels at or below 2.5 ng/mL, BMI of 32 kg/m2 or less, a hematocrit of less than 51%, and PSA values below 2.0 ng/mL. The patch treatment consisted of two 60 cm2 patches applied in the morning and worn for 48 hours; the oral treatment consisted of two 40 mg capsules taken twice daily.
The primary end points were changes from baseline to the end of each treatment period in serum levels of testosterone, luteinizing hormone, follicle stimulating hormone, and sex hormone-binding globulin (SHBG). Clinical scores were recorded using the Aging Male Symptoms Rating Scale (AMS) and the Male Sexual Function Questionnaire (MSF-4).
During the first treatment period, serum SHBG levels decreased with the oral treatment but were not affected by the transdermal patches. LH and FSH levels decreased similarly with both treatments. The patch was more effective than oral testosterone at improving AMS total score (10.3 vs. 8.9). With respect to psychological and sexual subscores, improvements were greater with the patch, according to the researchers.
These results were confirmed in the second treatment period when patients switched to the other treatment. “The oral treatment seems to cause fluctuations in testosterone, LH, FSH, and SHBG, and the levels go up and down and so you may not get as much efficacy,” Dr. Raynaud said. “The patch works similar to the hormone patches used for women and there are really no problems with compliance or skin irritation, and the patch is very discreet.”
No serious adverse effects were reported with either treatment, although some site irritation occurred with the patch (16% of patients) and some GI side effects occurred with the oral medication (8%). Compared with baseline values, PSA levels were slightly increased at the end of the first treatment period, from 0.78 to 0.96 ng/mL (patch) and 0.81 to 0.96 ng/mL (oral agent).