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Qualitative Synthesis






Oral testosterone versus no treatment. In one open label trial outcomes for efficacy and harms were compared between oral testosterone and no treatment.324 In this study, 48 diabetic men aged 45–65 years, with ED, increased abdominal girth, and symptoms of mild androgen deficiency, (total testosterone < 15.1 nmol/L) were randomized to either 120 mg oral testosterone undecanoate taken daily for 3 months or no treatment. Subjects were excluded from the trial if they had prostate abnormality or any illness considered likely to impair sexual function.

Harms. No adverse events were reported for this trial.

Efficacy. There was a statistically significant improvement in mean IIEF-5 scores (1=absent, 2=mild, 3 = mild to moderate, 4 = moderate, and 5 = severe) at 3 months in testosterone-treated patients compared with those with no treatment assigned (1.06 versus 2.25, p < 0.05).

Oral testosterone versus placebo. The outcomes for efficacy and harms associated with the use of oral testosterone versus placebo were compared in two trials.316, 319 In the first trial, 150 men aged 60–74 years, with symptoms attributed to androgen decline, including decreased libido and erectile quality, and free testosterone < 6 pg/ml, were randomized to either 160 mg oral testosterone undecanoate taken daily for 6 months, or 2 gm propionyl-L-carnitine plus 2 gm acetyl-L-carnitine daily or placebo.319Exclusion criteria were prostate enlargement, elevated PSA, and significant LUTS. In the second trial, 76 men aged 60–86 years, with at least two symptoms on the ADAM questionnaire, total testosterone < 8 nmol/L, and a free testosterone index (FTI) between 0.3 and 0.5, were randomized either to 80 mg oral testosterone undecanoate taken twice daily for 12 months or placebo.316Patients with a history of prostate cancer, elevated PSA, and significant LUTS were excluded.

Harms. In the first trial, the difference in the occurrence of adverse events between the two treatment groups was not statistically significant. Epigastralgia was reported in 2.5 percent of testosterone-treated versus 2.2 percent of placebo-treated subjects. In the second trial, the occurrence of adverse events was not reported.

Efficacy. In the first trial319, men assigned to receive testosterone had median IIEF sexual intercourse satisfaction scores (range 0–15) of 5 (range 3–10) at 6 months (p < 0.01). The corresponding median score for patients receiving placebo was 4 (range 3–5). The median IIEF-“EF domain” scores at 6 months of followup for men assigned to receive testosterone and placebo were 16 (range 6–29) and 8 (range 5–21), respectively.319 In the second trial, 86 percent and 93 percent of men in the testosterone and placebo group, respectively, reported that their erections were “less strong” at 12 weeks of the followup.316

Oral testosterone versus oral testosterone plus sildenafil. One trial evaluated and compared the efficacy and harms between oral testosterone alone and oral testosterone combined with sildenafil.145 This study enrolled 20 men (mean age: 56 years) with ED of > 6 months duration and symptoms of partial androgen deficiency (mean baseline total testosterone 7.3 nmol/L) who failed to respond to 50–100 mg sildenafil given twice weekly for 2 weeks. These men were randomized to 2 months of treatment with either oral testosterone undecanoate alone (120 mg/d) or oral testosterone undecanoate (120 mg/d) plus sildenafil (50–100 mg). Patients with prostate hypertrophy, prostate cancer, and mammary carcinoma were excluded.

Harms. The study reported that apart from mild headache occurring in three patients taking sildenafil 100 mg, no serious adverse events were observed.145

Efficacy. Men in the oral testosterone group reported no significant change in their IIEF-5 scores from 9.9 (SD 1.4) at baseline to 11.1 (1.5) at 2 months (p = 0.27), whereas men in the oral testosterone plus sildenafil group scored 10.1 (1.3) at baseline and 15.0 (1.4) at 2 month followup (p < 0.01).

Oral testosterone versus propionyl-L-carnitine plus acetyl-L-carnitine. One trial evaluated and compared the efficacy and harms for oral testosterone versus propionyl-L-carnitine plus acetyl-L-carnitine.319 In this study, 150 men aged 60–74 years, with symptoms of androgen decline, and free testosterone below 6 pg/mL, were randomized to receive either 160 mg oral testosterone undecanoate daily for 6 months or 2 gm propionyl-L-carnitine plus 2 gm acetyl-L-carnitine daily or placebo.319 Exclusion criteria were prostate enlargement, elevated PSA, and significant LUTS. Results comparing testosterone and propionyl-L-carnitine plus acetyl-L-carnitine are reported here.

Harms. The occurrence of adverse events was not statistically significantly different between the two treatment groups. Epigastralgia was reported in 2.5 percent of the testosterone-treated versus 0 percent of propionyl-L-carnitine plus acetyl-L-carnitine-treated subjects. Mild headache was reported for 2.2 percent of the propionyl-L-carnitine plus acetyl-L-carnitine-treated subjects versus 0 percent for testosterone-treated subjects.

Efficacy. At 6 months, in men assigned to receive testosterone, the median IIEF-“EF domain” score changed from 8 (range 5–19) at baseline to 16 (range 6–29) (within-group difference: p < 0.01). The corresponding median score in those assigned to the propionyl-L-carnitine plus acetyl-L-carnitine group changed from 8 (range 5–22) to 24 (range 8–29) (within-group difference: p < 0.01).

Oral testosterone plus sildenafil versus sildenafil. One trial evaluated and compared the efficacy and harms outcomes of oral testosterone plus sildenafil compared with sildenafil alone.145 This study enrolled 20 men (mean age: 56 years) with ED of > 6 months and symptoms of partial androgen deficiency (mean baseline total testosterone 7.3 nmol/L) who partially responded to previous sildenafil therapy (50–100 mg twice weekly for 2 weeks). The men were randomized to receive a 2-month treatment with either oral testosterone undecanoate (120 mg daily) plus sildenafil (50–100 mg) or sildenafil alone. Patients with prostate hypertrophy, prostate cancer, and mammary carcinoma were excluded.

Harms. Apart from mild headaches occurring in three patients taking sildenafil 100 mg, no serious adverse events were observed.

Efficacy. At 2 months of followup, the difference in mean IIEF-5 scores between patients who received the oral testosterone plussildenafil versus the sildenafil monotherapy groups was not statistically significant (17.5 versus 15.9, p ≥ 0.05).

Intramuscular Testosterone (IM) versus placebo. Four trials compared the efficacy and harms of IM testosterone and placebo.323, 325, 326, 328

In the first trial, 323 nine gonadotropin-deficient males aged 15 years or older (range 16–20) and currently being treated for hypopituitarism, only 3 of whom had partners, were randomized to 1 cc IM testosterone enanthate every 2 weeks versus 2000 units human chorionic gonadotropin three times weekly versus placebo. The active treatment arms each lasted for at least 6 months, while the placebo treatment lasted for 2 months.

In the second trial, 326 18 men, aged 45–74 years, with ED) were randomized either to IM testosterone enanthate 200 mg given twice weekly for 6 weeks or IM placebo. Patients with major disorders, a history of substance abuse, obesity, or major psychopathology were excluded from the trial.

In the third trial, 325 74 HIV-positive men (CD4 < 400), with ED or substantial loss of sexual desire, with low-to-normal levels of totaltestosterone (< 22.6 nmol/L if the patient had AIDS plus wasting or fatigue, or otherwise < 17.4 nmol/L) and at least one mood symptom of hypogonadism, were randomized either to IM testosterone cypionate 400 mg given twice daily for 6 weeks or placebo.

In the fourth trial, 328 32 men ≥ 35 years (mean age: 52 years) with depression and total testosterone 350 ng/dL were randomized either to IM testosterone enanthate 200 mg given once weekly for 6 weeks or IM placebo. Patients with psychiatric disorders or abnormal prostate exam result (men aged > 50 years) were excluded.

Harms. In two trials, 323, 326 no adverse events were reported. In the third trial, 325 men who received testosterone were more likely to report acne (testosterone: 20.5 percent versus placebo: 0 percent). Differences between men in the testosterone and placebo groups with respect to the occurrence of irritability (17.9 versus 17.1 percent) and testicular atrophy (5.1 versus 0 percent), were not statistically significant. In the fourth trial, 328 it was reported that no adverse events occurred except that one placebo-treated subject had a MI.

Efficacy. In the first trial, 323 weekly frequency of erections in the testosterone and placebo treatment groups were 7.9 (SD 6.1) and 4.9 (SD 3.3), respectively. The between-group difference was not statistically significant.

In the second trial, 326 results were based on 12 (67 percent) men who completed all assessments. At week 6, men in the IMtestosterone group reported a median number of “sex with partner” of 1.25 times per week versus 0.54 times per week for men in the placebo group (between-group difference: p ≥ 0.05). There was no difference in the degree of erection during sex with partner (scale 1–6, with = “none” and 6 = “full”), with a mean score of 5.5 for each group, or in the degree of erection during masturbation.

In the third trial, 325 results were reported for the 52 men (70 percent) who completed the treatment schedule. Within this group, 62.5 percent of men who received testosterone versus 20 percent of those who received placebo reported that their erectile function was much or very much improved (RR = 3.12, 95 percent CI: 1.25–7.82).

In the fourth trial, 328 the difference in frequency (1 = less than 1 per month” and 2 = 1–2 per month”) of full erections during one month between men in the IM testosterone and IM placebo groups was not statistically significant (1.77 versus 1.53)

Testosterone (IM) versus human chorionic gonadotropin (IM). One trial compared the efficacy and harms of IM testosterone versus IM human chorionic gonadotropin. 323 In this trial, 9 gonadotropin-deficient men aged 15 years or older (range 16–20) being treated for hypopituitarism, were randomized to 1 cc IM testosterone enanthate given every 2 weeks versus 2000 units of human chorionic gonadotropin 3 times weekly versus placebo. The active treatment arms each lasted for at least 6 months, while the placebo treatment lasted for 2 months.

Harms. No adverse event data were reported.

Efficacy. The weekly frequency of erection was not different between the two groups of testosterone and human chorionic gonadotropin treatment (7.9 versus 8.2).

Gel testosterone versus placebo. The efficacy and harms of gel testosterone versus placebo were compared in one trial 317 In this trial, 406 hypogonadal men (total T < 300 ng/dL) aged 20–80 years (mean age: 58 years) reporting one or more symptoms of low testosterone deficiency (i.e. fatigue, decreased muscle mass, reduced libido), were randomized to 50 mg gel testosterone (Testim) daily versus 100 mg gel testosterone (Testim) daily versus 24.4 mg patch testosterone (Androderm) versus placebo.

Harms. In total, 29.3 percent of men receiving 50 mg gel testosterone; 36.8 percent receiving 100 mg gel testosterone and 40.4 percent receiving placebo reported at least one treatment-related adverse event (including application site reactions, BPH, increase in blood pressure, increase in hematocrit, gynecomastia, headache, hot flashes, insomnia, mood swings, or spontaneous erections). These differences were not statistically significant. One participant from the group treated with 50 mg gel testosterone, five in the group treated with 100 mg gel testosterone, and none treated with placebo withdrew due to an adverse event.

Efficacy. At day 30, among men with sexual partners (63 percent of randomized men), 24 percent of placebo-treated men reported an increase from baseline in the number of days in the past week with sexual intercourse, compared with 31 percent of 50 mg geltestosterone-treated men (p < 0.05 versus placebo) and 39 percent of 100 mg gel testosterone men (p = 0.0096 versus placebo).

Gel testosterone versus patch testosterone. The efficacy and harms of gel testosterone versus patch testosterone was compared in three trials.317, 320, 327 In the first trial, 327 227 men aged 19–68 years (mean age: 58 years) with total testosterone levels < 10.4 nmol/L (300 ng/dL) were randomized to 50 mg gel testosterone (Androgel) given daily versus 100 mg gel testosterone (Androgel) given daily versus 5 mg patch testosterone (Androderm) given daily. Patients with increased PSA, significant skin disease, and substantial under- or overweight were excluded.

The other two trials 317, 320 had similar protocols. The inclusion criteria were low total testosterone (≤ 10.4 nmol/l320 and ≤ 300 ng/dL317) and/or symptoms of hypogonadism (i.e. fatigue, decreased muscle mass, reduced libido, or “reduced sexual functioning” of nonmechanical origin). Both trials randomized men to 50 mg gel testosterone (Testim) daily versus 100 mg gel testosterone (Testim) daily (deliver a daily dose of 5 and 10 mg testosterone, respectively). The first of these trials included an additional group randomized to 5 mg patch testosterone (Andropatch), 320 and the second trial randomized two additional groups to 24.4 mg patch testosterone and placebo.317

In the first of these trials, 320 men were to remain on their initially assigned treatment dose throughout the 90 day study, but in the second trial, 317 titration from the initial gel testosterone dose was possible at 60 days.

Harms. In the first trial, 327 skin irritation was reported by 5.7 percent of men who received 50 mg gel testosterone, 5.3 percent of those who received 100 mg gel testosterone, and 65.8 percent of those who received patch testosterone. Urogenital adverse events (e.g. prostate enlargement, increased PSA) were reported by 9.6 percent of men who received 50 mg gel testosterone, 5.1 percent of those who received 100 mg gel testosterone, and 0 percent of those who received patch testosterone.

In the other two trials, 317, 320 approximately 30–35 percent of men who received either of the gel testosterone groups versus 60 percent of those who received patch testosterone reported at least one treatment-related adverse event. Most common adverse events were skin application site reactions and less frequent events were BPH, increase in blood pressure, increase in hematocrit, gynecomastia, headache, hot flashes, insomnia, mood swings, or spontaneous erections. The second of these trials317 reported that withdrawals due to adverse events occurred in one 50 mg gel testosterone subject, five 100 mg gel testosterone subjects, and 15 patch testosterone subjects. In the same trial, two patients in the patch testosterone arm were diagnosed with prostate cancer.317

Efficacy. In the first trial, 327 patients in the gel testosterone group experienced slightly greater sexual enjoyment compared with those receiving the testosterone patch (p = 0.0113).

In the second trial, 320 compared with baseline, men in the 50 mg gel testosterone, 100 mg gel testosterone, and patch testosterone groups experienced 38, 50 and 33 percent improvement in “sexual performance” (within-group comparison: p < 0.05; between-group comparisons: p ≥ 0.05). Similarly, all three groups significantly improved from baseline, but without between-group differences for the domains of sexual motivation and sexual desire. Although spontaneous erections were significantly increased in frequency compared with baseline in both gel testosterone groups, and not in the patch testosterone group, there were no significant between-treatment group differences.

In the third trial, 317 at baseline approximately 20 percent of men reported having no sexual partner available, and approximately 45 percent reported no sexual intercourse during the past week. At day 30, among men with sexual partners for whom these data were reported (61 percent of randomized men), 31 percent of 50 mg gel testosterone men reported an increase from baseline in the number of days in the past week with sexual intercourse versus 39 percent of 100 mg gel testosterone men (versus 50 mg, p ≥ 0.05, and versus patch, p = 0.03) and 21 percent of patch testosterone men (versus 50 mg group, p ≥ 0.05).

Gel testosterone versus gel testosterone plus tadalafil. One trial compared the efficacy and harms of gel testosterone versus gel testosterone plus tadalafil.231 This trial enrolled 69 hypogonadal men (total testosterone < 3.4 ng/ml) aged 34–78 years (mean: 59 years), who had > 6 months of ED and a history of nonresponse (i.e. poor IIEF score or persistent patient/partner dissatisfaction) to 20 mg tadalafil. Men were randomized to 50 mg gel testosterone (Testogel) daily for 4 weeks followed by concurrent treatment with tadalafil 20 mg twice weekly for 9 weeks versus 50 mg gel testosterone (Testogel) daily for 10 weeks followed by concurrent treatment with tadalafil 20 mg twice weekly for 3 weeks. All treatments were open label.

Harms. No adverse events were observed.

Efficacy. At 10 weeks, there was no difference between treatment groups in mean IIEF intercourse satisfaction score (13.1 +/- 0.8 versus 12.8 +/- 0.9, WMD = 0.30, 95 percent CI: -0.10 to 0.70). After 13 weeks, 66.7 percent of patients were rated sufficient to good for successful intercourse completion in group one versus 63.6 percent in group two (RR = 1.05, 95 percent CI: 0.68– 1.62), and 47.6 percent of patients were rated sufficient to good for intercourse frequency in group one versus 59.1 percent in group two (RR = 0.81, 95 percent CI: 0.46–1.42).

Gel testosterone plus sildenafil versus sildenafil. This double-blind trial5 studied 75 men aged 26–79 years (mean age: 58 years) with ED of > 3 months, and total testosterone < 400 ng/dL. The men, refractory to prior sildenafil therapy were randomized to 1 percent gel testosterone daily plus 100 mg sildenafil once daily for each day with sexual activity as needed for 12 weeks versus 100 mg sildenafil as needed. Exclusion criteria were: history of prostate cancer, prostate disease with diminished urine flow rate, neurologic ED, substance abuse, or significant or uncontrolled medical or psychiatric conditions.

Harms. One subject in gel testosterone plus sildenafil arm withdrew due to adverse events. There were no withdrawals due to adverse events among patients receiving sildenafil alone.

Efficacy. In men receiving gel testosterone plus sildenafil, the mean number of successful sexual attempts (per week) ranged from 1.7 to 2.1. The corresponding range for those receiving sildenafil was 1.5–2.4 per week. At the end of the study, the proportions of men with scores of 4–5 on IIEF-Q3/Q4 was statistically nonsignificantly greater in the combination therapy group than in the sildenafil only group (51.4 versus 39.4 percent; RR = 1.30, 95 percent CI: 0.77–2.21). Men who received gel testosterone plus sildenafil had greater mean change from baseline in the IIEF “EF” domain score compared with those receiving sildenafil and placebo. The between-group differences were statistically significant at week 4 (4.4 versus 2.1, 95 percent CI: 0.3–4.7).

Cream testosterone versus cream testosterone plus isosorbide dinitrate plus co-dergocrine. One trial compared the efficacy and harms of cream testosterone versus cream testosterone plus isosorbide dinitrate plus co-dergocrine.322 In this two phase crossover trial, 42 men aged 41–67 years (mean: 54 years) with ED, decreased libido and total testosterone 200–350 ng/dl were randomized to 0.8 percent cream testosterone versus 0.8 percent cream testosterone plus 0.5 percent isosorbide dinitrate plus 0.06 percent co-dergocrine. Each treatment was to be applied daily at bedtime to the penile shaft and glans; if intercourse was going to occur then the cream was applied 15 minutes before intercourse. Each arm of the crossover lasted 30 days.

Harms. Five men who received combination therapy reported a mild transient headache versus none who received creamtestosterone alone. No significant increase in PSA occurred.

Efficacy. In total 67 percent of men who received cream testosterone plus isosorbide dinitrate plus co-dergocrine reported a complete response to treatment (full erection and sexual interest compared with 31 percent of men who received cream testosterone alone (RR = 2.15, 95 percent CI: 1.31–3.55). Among men with psychogenic ED (n = 19), 84.2 percent of those who received combination therapy reported a complete response versus 57.9 percent of those who received cream testosterone alone (RR =1.45, 95 percent CI: 0.95–2.24). Among men with vascular ED (n=18), 55.6 percent of those who received combination therapy reported a complete response versus 11.1 percent of those who received cream testosterone alone (RR = 5.00, 95 percent CI: 1.27–19.68). Among men with neurogenic ED (n = 5), two who received combination therapy reported a complete response versus none who received cream testosterone alone. Among all men with complete responses, those who received cream testosterone plus isosorbide dinitrate plus co-dergocrine reported a mean of 6.46 (SD 2.7) full erections with satisfactory intercourse per month versus 4.05 (SD 1.8) for men who received cream testosterone only (WMD = 2.41, 95 percent CI: 1.43 to -3.39).

Cream testosterone plus isosorbide dinitrate plus co-dergocrine versus placebo. One trial compared the efficacy and harms of cream testosterone plus isosorbide dinitrate plus co-dergocrine versus placebo.329) In this trial, 89 men aged 35–65 years (mean: 54 years) with more than 5 months of decreased libido and of decreased frequency and quality of sexual erections, and total testosterone < 300 ng/dL, were randomized to 0.8 percent cream testosterone plus 0.5 percent isosorbide dinitrate plus 0.06 percent co-dergocrine versus placebo. Each treatment was applied twice daily to the shoulder for two months. Patients with abnormal rectal exam results, PSA > 4 ng/ml, and urine flow rate < 12 ml/second were excluded.

Harms. Among men who received combination treatment, 11.1 percent reported headaches, 2.2 percent reported skin irritation (versus 0 percent for placebo subjects). Neither treatment group reported priapism.

Efficacy. Of men who received combination therapy, 40 percent reported at least one full erection with successful intercourse during followup versus 0 percent of those who received placebo. No men who received placebo reported full erections after two months of treatment in any ED etiology subgroup, whereas among men who received combination treatment, full erections were reported by 68.8 percent of men with psychogenic ED (n = 11/16), 11.1 percent of men with vascular ED (n = 1/9), 37.5 percent of men with neurogenic ED (n = 3/8), and 25 percent of men with mixed ED (n = 3/12). Men who received combination therapy also reported improved enjoyment with partner and satisfaction with intercourse.

Patch testosterone versus placebo. The efficacy and harms of patch testosterone versus placebo were evaluated and reported in two trials.317, 330 The design and study population of the first trial317 are described elsewhere in two other sections: Gel Testosterone versus Placebo and Gel Testosterone versus Patch Testosterone. In the second trial, 330 39 “borderline” hypogonadal men (total testosterone < 10 nmol/l or a free androgen index < 30 percent) aged 40–77 years (mean: 62 years) were randomized to 6 months of treatment either with 5 mg patch testosterone (Testoderm) once daily or placebo.

Harms. In the first trial, 317 62.7 percent of men assigned to the patch testosterone group versus 40.4 percent of those in the placebo group had at least one treatment-related adverse event. Withdrawals due to a skin reaction occurred in 15 percent of patch testosterone subjects, but not in placebo subjects.

In the second trial, 330 15 percent of patch testosterone subjects and 5.3 percent of placebo subjects had an increased hematocrit. One subject assigned to the placebo group developed angina.

Efficacy. In the first trial, 317, among men with sexual partners (62 percent of randomized men), 24 percent of men receiving placebo reported an increase from baseline in the number of days in the past week with sexual intercourse, compared with 21 percent of men receiving patch testosterone (p ≥ 0.05, versus placebo).

In the second trial, 330 men who received placebo had a statistically significantly greater decline from baseline in their Male Erectile Dysfunction Quality of Life questionnaire (MEDQoL) score (range 0–100) compared with men who received patch testosterone (from 61.4 at baseline to 61.8 at followup for patch testosterone versus from 54.2 at baseline to 43.6 at followup for placebo) (p = 0.017).

Patch testosterone plus sildenafil versus sildenafil. One open label trial compared the efficacy and harms of patch testosterone plus sildenafil versus sildenafil.77 This trial enrolled 20 men aged 48–66 years (mean age: 56 years), with arteriogenic ED of ≥ 6 months duration, and refractory to prior sildenafil therapy, The inclusion criteria were: total testosterone 10–13 nmol/L and free testosterone 200–300 pmol/lL, no response to previous treatment with 100 mg patch testosterone, and an IIEF erectile function score of less than 24 in response to 100 mg sildenafil. Men with a history of hematological disorders or prostate disease were excluded. Men were randomized to 5 mg patch testosterone daily plus 100 mg sildenafil, as needed for one month versus placebo patch daily plus 100 mg sildenafil, as needed.

Harms. Data on adverse events was not reported.

Efficacy. Men who received placebo patch plus sildenafil did not improve in erectile function compared with baseline on any IIEF question or domain reported. Those in the combination group (patch testosterone plus sildenafil) had a greater endpoint percentage of successful intercourse attempts (data not provided), higher “EF domain” scores (21.8 +/- 2.1 versus 14.2 +/- 0.7, WMD = 7.60, 95 percent CI 6.23–8.97), an increased number of sexual intercourses (2.8 +/- 0.9 versus 1.5 +/- 0.5, WMD = 1.30, 95 percent CI 0.66–1.94), greater intercourse satisfaction (12.1 +/- 1.6 versus 7.7 +/- 1.2, WMD = 4.40, 95 percent CI 3.16–5.64), and more frequently reported that treatment had improved their erections (80 versus 10 percent, RR = 8.00, 95 percent CI: 1.21–52.69).

Dihydrotestosterone gel versus placebo. One trial compared the efficacy and harms of dihydrotestosterone gel versus placebo.321 This trial enrolled 120 men with nocturnal penile tumescence no more than once weekly, at least one symptom of andropause (decreased libido, ED, “urinary disorder, ” asthenia, or depressed mood), and total serum testosterone < 15 nmol/L and/or SHBG > 30 nmol/L. Men were randomized to daily dihydrotestosterone gel versus placebo for 6 months. Dihydrotestosterone gel was initiated at 125 mg daily and could be titrated to 250 mg daily after 30 days according to DHT levels.

Harms. Of men who received dihydrotestosterone gel, 5 percent reported mild headache (versus 3.3 percent for placebo) and 3.3 percent reported mild depression (versus 3.3 percent for placebo).

Efficacy. At baseline and 6-month followup, participants rated their ability to maintain erection during intercourse on a scale of 1–6, in which 2 = “75 percent of intercourses” and 3 = “50 percent of intercourses. Mean scores reported for participants who received dihydrotestosterone were 2.26 at baseline and 3.24 at 6 months, whereas those for the participants in the placebo group were 2.53 at baseline and 2.81 at followup (p = 0.04 for mean change from baseline between treatment groups).






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