Table 1.
Summary of efficacy data from testosterone trials using T gel in hypogonadal men
| First author, Ref | Patient details | Blinding | Control group | Regimen | Duration | Results |
|---|---|---|---|---|---|---|
| Wang et al42 | 227 hypogonadal men aged 19–68 years (Total T < 10.4 nmol/L) | Androgel treatments were double-blinded but Androderm was open-labeled | None | Randomized to receive –
|
180 days | At 90 days of treatment, lean body mass increased more in the 100 mg/day T gel group (2.74 ± 0.28 kg; P = 0.0002) than in the 50 mg/day T gel (1.28 ± 0.32 kg) and T patch groups (1.20 ± 0.26 kg). Fat mass and percent fat were not significantly decreased in the T patch group, but showed decreases in the T gel groups (50 mg/day, −0.90 ± 0.32 kg; 100 mg/day, −1.05 ± 0.22 kg). Sexual function and mood improved maximally on day 30 of treatment, without differences across groups, and showed no further improvement with continuation of treatment. Mean muscle strength in the leg press exercise increased by 11 to 13 kg in all treatment groups by 90 days and did not improve further at 180 days of treatment. Moderate increases were also observed in arm/chest muscle strength |
| Wang et al52 | 227 hypogonadal men aged 19–68 years (Total T < 10.4 nmol/L) | Androgel treatments were double-blinded but Androderm was open-labeled | None | Randomized to receive –
|
180 days | Urine N-telopeptide/creatinine ratio, a marker for bone resorption, decreased significantly (P = 0.0019) only in the T gel 100 mg/day group. Serum bone osteoblastic activity markers (osteocalcin, procollagen and skeletal alkaline phosphatase) increased significantly during the first 90 days of treatment without intergroup differences but declined to baseline thereafter. BMD increased significantly both in the hip (+1.1 ± 0.3%) and spine (+2.2 ± 0.5%) only in the T gel 100 mg/day group (P = 0.0001) |
| McNicholas et al27 | 208 hypogonadal men aged 31–80 years (Total T < 10.4 nmol/L) | Testim treatments were double-blinded but Androderm was open-labeled | None | Randomized to receive –
|
90 days | Both doses of Testim significantly improved positive and negative mood over baseline; Andropatch did not. All three treatments increased lean body mass, and the higher dose of Testim produced a significant decrease in percentage body fat (−0.12%, P < 0.01). At all sample times both doses of Testim significantly improved sexual performance, sexual motivation, sexual desire and spontaneous erections. Andropatch provided insignificant improvements from baseline at all sample times for sexual desire, an inconsistent improvement in sexual motivation, but no effect on spontaneous erections |
| Steidle et al29 | 406 hypogonadal men aged 20–80 years (Total T < 10.4 nmol/L) | Testim treatments were double-blinded but Androderm was open-labeled | Placebo | Randomized to receive –
|
90 days | At day 90, the 100 mg/day Testim treatment improved lean body mass by 1.7 kg and percentage of body fat by 1.2% to a significantly greater degree than either control treatment. Reductions in fat mass of 0.8 ± 2.4, 0.8 ± 2.0, 0.4 ± 1.8, and 0.1 ± 1.5 kg were noted in the 50 mg/day Testim gel, 100 mg/d Testim gel, Androderm patch, and placebo treatment groups, respectively. Reductions in % fat were evidenced in all treatment groups, with the Testim treatments yielding the most notable decreases. The 100 mg/day Testim treatment resulted in a 1.2 ± 1.9% reduction at d 90, which was not only parison with the T patch treatment (0.5 ± 1.6%, P 0.05). Significant improvements in spontaneous erections, sexual desire, and sexual motivation were also evidenced with the 100 mg/d Testim dose in comparison with placebo |
| Loizides et al54 | 638 hypogonadal men aged 18–86 (T < 300 ng/dL) | Open | None | Single group study receving 1% Testim (50 mg/day) and could increase up to 100 mg/day at the discretion of theinvestigator | 30 days | Average score for sexual desire, sexual motivation, spontaneous erections (daytime and nighttime), sexual performance, sexual enjoyment, and satisfaction showed a significant increase from baseline by the end of the first week and generally reached a maximal response by the end of the second week, which was maintained for the remainder of the month of therapy with Testim. Both measures of positive mood and negative mood improved significantly, beginning with the first week of therapy and reaching and maintaining a maximal response at the second week |
| Dean et al30 | 371 hypogonadal men aged 21–81 (Total T < 300 ng/dL) were recruited from those who had completed two short-term double-blind studies with Testim | Open | None | Single group study receving 1% Testim (5 g/day) and could increase up to 100 mg/day based on serum T levels and clinical symptoms | 12 months | Testim treatment resulted in significant changes in body composition at months 6 and 12 (Figures 5–7). These changes included significant increases in lean body mass 1.7 kg [month 6] and 2.2 kg [month 12]), significant decreases in fat mass (1.2 kg [month 6] and 1.8 kg [month 12]), and % fat (1.4% [month 6], and 2.1% [month 12]) but with no significant change in total body mass. Long-term treatment with Testim resulted in a significant (P < 0.001) percent change increase from baseline in BMD of the lumbar spine as measured by DEXA scan, reaching 2.58% at month 12. In addition, significant improvements in mood and sexual function were maintained for up to 12 months of treatment |
| Wang et al26 | 163 hypogonadal men (mean age 51.4 yrs) were recruited form those who were in the six-month study using Androgel or Androderm to continue for an additional 36 months | Open | None | Those who were receving 5 g/day or 10 g/day of Androgel continued in the same group. Men receiving Androderm were assigned to Androgel, 5 g/day. Dose were adjusted in future visits based on T levels and clinical symptoms | 42 months | Lean body mass increased (P = 0.0001) and fat mass decreased (P = 0.0001), and these changes were maintained with treatment but were not accompanied by significant increases in muscle strength. Increases in serum bone markers suggestive of increased bone formation were followed by gradual and progressive increases in bone mineral density more in the spine (P = 0.0001) than the hip (P = 0.0004). Sexual function and mood parameters improved rapidly and were maintained throughout T treatment |
| Steidle et al43 | 151 hypogonadal men (Total T < 10.4 nmol/L pre-treatment) who failed to experience satisfactory symptom relief of sexual dysfunction after treatment with Androgel | Open | Androgel 5 g/day | Testim 5 g/day (treatment group) or Androgel 5 gm/day (control group) | 4 weeks | Changes from baseline in the 5 domains of the Brief Male Sexual Function Inventory were compared between groups. The mean percentage improvement favored Testim treatment in sexual drive (23% vs 16%, P < 0.3), erectile function (32% vs 8%, P < 0.03), ejaculatory function (11% vs 9%, P < 0.4), problem assessment (47% vs 12%, P < 0.01), and sexual satisfaction (62% vs 23%, P < 0.02). A greater percentage of subjects also reported satisfaction with the experimental treatment (55% vs 33%, P < 0.02), and these subjects were less likely to require upward dose titration at the final follow-up visit (53% vs 72%,P < 0.03) |
| Kuhnert et al28 | 162 hypogonadal men over 18 years (Total T < 10 nmol/L) | Open | None | Randomized to receive
|
24 weeks | Whereas serum testosterone levels and the pre-post changes of the areas under the curve of testosterone and free testosterone between weeks 0 and 24 indicated equivalent treatment success for the patch and scrotal groups, the dermal gel group was significantly superior to the other twogroups |
| Schrader et al61 | 48 HIV-positive hypogonadal males who failed to experience satisfactory symptom relief following prior treatment with Androgel 1% | Open | Androgel 5 g/day | Testim 5 g/day (treatment group) or Androgel 5 gm/day (control group) | 4 weeks | The average percentage improvement favored the experimental treatment in all five 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) |
| Scott et al32 | 30 HIV-positive hypogonadal males over aged 31–66 years who were alredy receving IM testoster-one with T levels in the Eugonadal range | Open | Internal cross-over | IM Testosterone cypionate 100–200 mg every 1–2 weeks 1% Androgel 5 g/day. Both doses were adjusted in future visits based on T levels and clinical symptoms | 16 weeks | Mean peak free testosterone concentrations with IM testosterone and T gel were 42 pg/mL and 23 pg/mL, respectively, and mean peak trough fluctuations in free testosterone were 26.7 ± 12.8 pg/mL and 2.7 ± 10.7 pg/mL, respectively (P < 0.001). Quality-of-life scores indicated more improved physical and emotional well-being with gel versus intramuscular testosterone. No significant changes in laboratory parameters or lean body mass were noted |
| Shabsigh et al57 | 75 hypogonadal men aged 17–80 years (TT < 400 ng/dL) with confirmed lack of response to ED to sildenafil | Double-blind | Placebo | 5 g/day of 1% Androgel or placebo gel + 100 mg of sildenafil/day | 12 weeks | Androgel treated subjects had greater improvement in erectile function compared to those who received placebo, reaching statistical significance at week 4 (4.4 vs 2.1, P = 0.029, 95.1% CI: 0.3, 4.7). Similar trends were observed for improvements in orgasmic function, overall satisfaction, total IIEF score and percentage of IIEF responders. T-gel significantly (P ≤ 0.004) increased total and free T levels throughout the study, although no significant correlations were made between testosterone levels and the IIEF at end point. Mean total QOL scores were similar between groups at baseline. Throughout the study changes in QOL were generally small but were consistently better in subjects who received T-gel versus placebo reaching significance at week 12 (P = 0.028) 95.1% CI: 0.0, 0.5) and approaching significance at end point |
Abbreviations: CI, confidence interval; T, Testosterone; IIEF, International Index of Erectile Function; QOL, Quality of life; BMSFI, Brief Male Sexual Function Inventory; BMD, Bone Mineral Density; IM, Intramuscular.