A randomized, double-blind, placebo-controlled trial on the effect of long-acting testosterone treatment as assessed by the Aging Male Symptoms scale

Chee Kong Christopher Ho, Tong Seng Fah, Wah Yun Low, Chirk Jenn Ng, Ee Ming Khoo, Verna K M Lee, Zulkifli Md. Zainuddin, Hui Meng Tan

Research output: Contribution to journalArticle

32 Citations (Scopus)

Abstract

OBJECTIVE: • To evaluate the effect of i.m. injection of testosterone undecanoate 1000 mg over 12 months on the Aging Male Symptom (AMS) scale scores in men with testosterone deficiency syndrome (TDS). PATIENTS AND METHODS: • A total of 120 men > 40 years old with TDS (total testosterone < 12 nmol/L and total AMS scores ≥ 27) were randomized into i.m. injection of either placebo or testosterone undecanoate 1000 mg. • In all, 56 and 58 participants from the active treatment and placebo groups, respectively completed the study. • An i.m. injection of either placebo or testosterone undecanoate 1000 mg was given at weeks 0, 6, 18, 30 and 48. • Self-administered AMS questionnaires were completed at weeks 0, week 18 and week 48. RESULTS: • Improvement in the total AMS score was significantly greater in the treatment group than in the placebo group (F: 4.576, P = 0.017) over the 48-week period. • The mean (SD) total AMS score was 38.46 (11.85) at baseline and 33.59 (1.69) at 48 weeks for the placebo group, and 41.73 (12.73) at baseline and 32.61 (9.67) at 48 weeks for the treatment group. • The mean change in the total AMS score was -12.6% in the placebo group and -21.9% in the treatment group. • The mean psychological and somatovegetative domain scores decreased significantly more in the treatment group than in the placebo group (-2.8 vs -1.2, P = 0.03; and -3.2 vs -1.8, P = 0.016). • The difference in change between the randomized groups for the sexual domain scores followed the same trend, though the difference was not significant. CONCLUSION: • Long-acting testosterone is effective in improving health-related quality of life as assessed by the AMS scale in men with TDS.

Original languageEnglish
Pages (from-to)260-265
Number of pages6
JournalBJU International
Volume110
Issue number2
DOIs
Publication statusPublished - Jul 2012

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Testosterone
Placebos
Therapeutics
Injections
Quality of Life
Psychology
testosterone undecanoate

Keywords

  • AMS scale
  • Hypogonadism
  • Injectable
  • Long-acting
  • Testosterone deficiency
  • Testosterone undecanoate

ASJC Scopus subject areas

  • Urology

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A randomized, double-blind, placebo-controlled trial on the effect of long-acting testosterone treatment as assessed by the Aging Male Symptoms scale. / Ho, Chee Kong Christopher; Seng Fah, Tong; Low, Wah Yun; Ng, Chirk Jenn; Khoo, Ee Ming; Lee, Verna K M; Md. Zainuddin, Zulkifli; Tan, Hui Meng.

In: BJU International, Vol. 110, No. 2, 07.2012, p. 260-265.

Research output: Contribution to journalArticle

Ho, Chee Kong Christopher ; Seng Fah, Tong ; Low, Wah Yun ; Ng, Chirk Jenn ; Khoo, Ee Ming ; Lee, Verna K M ; Md. Zainuddin, Zulkifli ; Tan, Hui Meng. / A randomized, double-blind, placebo-controlled trial on the effect of long-acting testosterone treatment as assessed by the Aging Male Symptoms scale. In: BJU International. 2012 ; Vol. 110, No. 2. pp. 260-265.
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abstract = "OBJECTIVE: • To evaluate the effect of i.m. injection of testosterone undecanoate 1000 mg over 12 months on the Aging Male Symptom (AMS) scale scores in men with testosterone deficiency syndrome (TDS). PATIENTS AND METHODS: • A total of 120 men > 40 years old with TDS (total testosterone < 12 nmol/L and total AMS scores ≥ 27) were randomized into i.m. injection of either placebo or testosterone undecanoate 1000 mg. • In all, 56 and 58 participants from the active treatment and placebo groups, respectively completed the study. • An i.m. injection of either placebo or testosterone undecanoate 1000 mg was given at weeks 0, 6, 18, 30 and 48. • Self-administered AMS questionnaires were completed at weeks 0, week 18 and week 48. RESULTS: • Improvement in the total AMS score was significantly greater in the treatment group than in the placebo group (F: 4.576, P = 0.017) over the 48-week period. • The mean (SD) total AMS score was 38.46 (11.85) at baseline and 33.59 (1.69) at 48 weeks for the placebo group, and 41.73 (12.73) at baseline and 32.61 (9.67) at 48 weeks for the treatment group. • The mean change in the total AMS score was -12.6{\%} in the placebo group and -21.9{\%} in the treatment group. • The mean psychological and somatovegetative domain scores decreased significantly more in the treatment group than in the placebo group (-2.8 vs -1.2, P = 0.03; and -3.2 vs -1.8, P = 0.016). • The difference in change between the randomized groups for the sexual domain scores followed the same trend, though the difference was not significant. CONCLUSION: • Long-acting testosterone is effective in improving health-related quality of life as assessed by the AMS scale in men with TDS.",
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AU - Low, Wah Yun

AU - Ng, Chirk Jenn

AU - Khoo, Ee Ming

AU - Lee, Verna K M

AU - Md. Zainuddin, Zulkifli

AU - Tan, Hui Meng

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N2 - OBJECTIVE: • To evaluate the effect of i.m. injection of testosterone undecanoate 1000 mg over 12 months on the Aging Male Symptom (AMS) scale scores in men with testosterone deficiency syndrome (TDS). PATIENTS AND METHODS: • A total of 120 men > 40 years old with TDS (total testosterone < 12 nmol/L and total AMS scores ≥ 27) were randomized into i.m. injection of either placebo or testosterone undecanoate 1000 mg. • In all, 56 and 58 participants from the active treatment and placebo groups, respectively completed the study. • An i.m. injection of either placebo or testosterone undecanoate 1000 mg was given at weeks 0, 6, 18, 30 and 48. • Self-administered AMS questionnaires were completed at weeks 0, week 18 and week 48. RESULTS: • Improvement in the total AMS score was significantly greater in the treatment group than in the placebo group (F: 4.576, P = 0.017) over the 48-week period. • The mean (SD) total AMS score was 38.46 (11.85) at baseline and 33.59 (1.69) at 48 weeks for the placebo group, and 41.73 (12.73) at baseline and 32.61 (9.67) at 48 weeks for the treatment group. • The mean change in the total AMS score was -12.6% in the placebo group and -21.9% in the treatment group. • The mean psychological and somatovegetative domain scores decreased significantly more in the treatment group than in the placebo group (-2.8 vs -1.2, P = 0.03; and -3.2 vs -1.8, P = 0.016). • The difference in change between the randomized groups for the sexual domain scores followed the same trend, though the difference was not significant. CONCLUSION: • Long-acting testosterone is effective in improving health-related quality of life as assessed by the AMS scale in men with TDS.

AB - OBJECTIVE: • To evaluate the effect of i.m. injection of testosterone undecanoate 1000 mg over 12 months on the Aging Male Symptom (AMS) scale scores in men with testosterone deficiency syndrome (TDS). PATIENTS AND METHODS: • A total of 120 men > 40 years old with TDS (total testosterone < 12 nmol/L and total AMS scores ≥ 27) were randomized into i.m. injection of either placebo or testosterone undecanoate 1000 mg. • In all, 56 and 58 participants from the active treatment and placebo groups, respectively completed the study. • An i.m. injection of either placebo or testosterone undecanoate 1000 mg was given at weeks 0, 6, 18, 30 and 48. • Self-administered AMS questionnaires were completed at weeks 0, week 18 and week 48. RESULTS: • Improvement in the total AMS score was significantly greater in the treatment group than in the placebo group (F: 4.576, P = 0.017) over the 48-week period. • The mean (SD) total AMS score was 38.46 (11.85) at baseline and 33.59 (1.69) at 48 weeks for the placebo group, and 41.73 (12.73) at baseline and 32.61 (9.67) at 48 weeks for the treatment group. • The mean change in the total AMS score was -12.6% in the placebo group and -21.9% in the treatment group. • The mean psychological and somatovegetative domain scores decreased significantly more in the treatment group than in the placebo group (-2.8 vs -1.2, P = 0.03; and -3.2 vs -1.8, P = 0.016). • The difference in change between the randomized groups for the sexual domain scores followed the same trend, though the difference was not significant. CONCLUSION: • Long-acting testosterone is effective in improving health-related quality of life as assessed by the AMS scale in men with TDS.

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