title: Improvement in sexual functioning and satisfaction in nonresponders to testosterone gel: clinical effectiveness in hypogonadal, HIV-positive males.
abstract: Impairment in gonadal function with reduced testosterone (T) levels is commonly associated with HIV infection and patients often complain of diminished libido and sexual dysfunction. The effectiveness of Testim 1% (Auxilium Pharmaceuticals, Inc., Norristown, Pennsylvania) topical T gel was evaluated in HIV-positive males who failed to experience satisfactory symptom relief following prior treatment with AndroGel 1% (Solvay Pharmaceuticals, Inc., Marietta, Georgia). In this open-label study, consecutive subjects were randomly assigned to experimental treatment with Testim 1% (5 g) or to maintenance therapy (control group) with AndroGel 1% (5 g). Twenty-four experimental subjects and 24 control subjects were followed for 4 weeks to evaluate improvements in sexual functioning and satisfaction. Changes from baseline in the 5 domains of the Brief Male Sexual Function Inventory (BMSFI) were compared between groups. The average percentage improvement favored the experimental treatment in all 5 comparisons of the BMSFI, including sexual drive (53% vs 18%, P < 0.001), erectile function (49% vs 7%, P < 0.004), ejaculatory function (15% vs 8%, P < 0.14), problem assessment (59% vs 12%, P < 0.003), and sexual satisfaction (58% vs 9%, P < 0.006). A greater percentage of subjects also reported satisfaction with the experimental treatment (85% vs 48%, P < 0.03), and these subjects were less likely to require upward dose titration at the final follow-up visit (30% vs 74%, P = 0.01). It is hypothesized that the results of the current study may be explained, in part, by an improved pharmacokinetic profile of the experimental intervention. Consideration of Testim 1% gel in HIV patients who have an inadequate response to prior T therapy is encouraged, although it is difficult to estimate the contribution of nonspecific study effects (eg, placebo) in this trial.
authors.affiliation: The Schrader Clinic, Houston, Texas, USA.
authors.forename: Shannon
authors.initials: S
authors.lastname: Schrader
authors.forename: Anthony
authors.initials: A
authors.lastname: Mills
authors.forename: Mark
authors.initials: M
authors.lastname: Scheperle
authors.forename: Jon E
authors.initials: JE
authors.lastname: Block
mesh_terms: D000328:Adult; D000728:Androgens / Q000008:administration & dosage*; D005500:Follow-Up Studies; D006679:HIV Seropositivity / Q000097:blood / Q000150:complications*; D006801:Humans; D007006:Hypogonadism / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D012725:Sexual Behavior / Q000502:physiology*; D013739:Testosterone / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000728:Androgens; D013739:Testosterone