An Exploratory Study of the Effects of 12 Month Administration of the Novel Long-Acting Testosterone Undecanoate on Measures of Sexual Function and the Metabolic Syndrome
Abstract
Administration of testosterone undecanoate (TU) over 12 months to men with sexual dysfunction and signs of the metabolic syndrome, restored their plasma testosterone (T) levels to the mid-range of reference values. This had a beneficial effect on their sexual functioning as evidenced by an improvement of their scores on the International Index of Erectile Function. The scores on the Aging Male Symptoms score, AMS, were also improved. Most impressive were the improvements in the parameters of the metabolic syndrome; they all improved and appeared largely correlated (i.e., decline in waist circumference with declines of plasma cholesterol and LDL and increase in plasma HDL). Sex hormone binding globulin, SHBG, may be considered as an indicator of the severity of the metabolic syndrome; levels of SHBG initially fell, probably as a result of rising plasma T levels. But over the last six months of the observation period when plasma T rose further, there was a significant increase in plasma SHBG which may be interpreted to indicate an improvement of the metabolic syndrome. Blood pressure improved slightly but significantly. In this cohort of elderly men (54-76 years; median 64 years) there were no safety concerns over a one year period of T administration. Prostate specific antigen, PSA, levels remained stable; the International Prostate Symptoms Score, IPSS, improved slightly. Liver functions and plasma glucose remained stable. Hemoglogin and hematocrit values increased significantly but remained within reference values.
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Effects of testosterone on erythropoiesis are evident at 3 months and peak at 9-12 months.
“Effects on erythropoiesis are evident at 3 months, peaking at 9–12 months.”
From Onset of effects of testosterone treatment and time span until maximum effects are achieved (2011) · cites this paper as [35]
Serum total cholesterol decreases as quickly as after 4 weeks of testosterone treatment, but most studies report a decrease after 3 months.
“Decreases in serum total cholesterol have been noted as quick as after 4 weeks (38, 39) but most studies have reported a decrease after 3 months (35, 36).”
From Onset of effects of testosterone treatment and time span until maximum effects are achieved (2011) · cites this paper as [35]
Low-density lipoprotein cholesterol decreases after 3 months, after 40-44 weeks, or after 12 months of testosterone treatment, with a maximum observed after 24 months.
“The decrease in low-density lipoprotein cholesterol seems somewhat slower: after 3 months (35), after 40–44 weeks, (44) or after 12 months (42) with a maximum observed after 24 months (32).”
From Onset of effects of testosterone treatment and time span until maximum effects are achieved (2011) · cites this paper as [35]
High-density lipoprotein cholesterol increases after 3 months, increasing further during 12 months, after 6 months, or close to 1 year, with continuous increase over 24 months.
“An increase was found to occur after 3 months increasing further during 12 months (43), after 6 months, (35) or close to 1 year (44). Continuous increase was observed over 24 months (32).”
From Onset of effects of testosterone treatment and time span until maximum effects are achieved (2011) · cites this paper as [35]
Testosterone treatment decreases trunk fat or waist circumference after 3 months, with continuous decline over 24 months.
“A decrease in trunk fat or waist circumference was noted in a number of studies after 3 months (35, 36) with continuous decline over 24 months (32)”
From Onset of effects of testosterone treatment and time span until maximum effects are achieved (2011) · cites this paper as [35]
Serum triglycerides decrease after 4 weeks and after 3 months of testosterone treatment, with further decrease over 9 or 12 months.
“The decrease in serum triglycerides follows a similar pattern: after 4 weeks (38), after 3 months (35), and with further decrease over 9 months (41) or 12 months (43).”
From Onset of effects of testosterone treatment and time span until maximum effects are achieved (2011) · cites this paper as [35]
Maximum blood pressure effects of testosterone treatment are observed after 12 months.
“Maximum effects were observed after 12 months (35).”
From Onset of effects of testosterone treatment and time span until maximum effects are achieved (2011) · cites this paper as [35]
Diastolic blood pressure declines after 3-9 months of testosterone treatment, and in some studies systolic blood pressure also declines.
“In some studies a decline in diastolic blood pressure has been observed, after 3–9 months (22, 35, 41, 44) and in some studies in systolic blood pressure also (35, 44).”
From Onset of effects of testosterone treatment and time span until maximum effects are achieved (2011) · cites this paper as [35]
Improvements on AMS scores are noted after 1 month, 6 weeks to 3 months, or after 9 months, continuing over a total of 18 months.
“Improvements on scores on the AMS have been noted after 1 month (38), 6 weeks (40) to 3 months on treatment with parenteral testosterone undecanoate (35) or after 9 months on testosterone gel (74) continuing over a total of 18 months (74).”
From Onset of effects of testosterone treatment and time span until maximum effects are achieved (2011) · cites this paper as [35]
Increases in IIEF erectile function occur after 3 months, while increases in IIEF sexual desire, intercourse satisfaction, and overall satisfaction appear after 6 weeks.
“Increases in the IIEF erectile function have been noted after 3 months (35, 40) but increases in IIEF sexual desire, intercourse satisfaction, and overall satisfaction appear already after 6 weeks (40).”
From Onset of effects of testosterone treatment and time span until maximum effects are achieved (2011) · cites this paper as [35]
In the authors' own studies, signs and symptoms of the metabolic syndrome improved substantially following administration of long-acting testosterone undecanoate, and improvements in glycemic control and lipids parallel improvements in body composition.
“In our own studies, signs and symptoms of the metabolic syndrome improved substantially following administration of long-acting testosterone undecanoate (32, 35, 92) and improvements in glycemic control and lipids parallel improvements in body composition.”
From Onset of effects of testosterone treatment and time span until maximum effects are achieved (2011) · cites this paper as [35]
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- Authors
- Saad, F., Gooren, L., Haider, A., & Yassin, A.
- Affiliations
- Gulf Medical University (AE)
- Amsterdam University Medical Centers (NL)
- Corresponding author
- Saad, Farid
- Venue
- Archives of Andrology
- Publisher
- Informa UK Limited
- Published
- 2007-01
- Volume
- 53
- Issue
- 6
- Pages
- 353-357
- ISSN
- 0148-5016 (ISSN-L)
- OpenAlex
- W2050614537
- Cited by
- 87
- References
- 23
- Citations by year
- 2026: 4 · 2024: 1 · 2023: 3 · 2022: 3 · 2021: 3 · 2020: 4 · 2019: 3 · 2018: 2 · 2017: 4 · 2016: 7 · 2015: 9 · 2014: 7 · 2013: 4 · 2012: 3
- FWCI
- 5.13
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Archives of Andrology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
- Health Sciences › Medicine › Psychiatry and Mental health › Sexual function and dysfunction studies
- Health Sciences › Medicine › Reproductive Medicine › Sperm and Testicular Function
- Keywords
- testosterone undecanoate, male sexual dysfunction, erectile dysfunction, metabolic syndrome, aging male symptoms, sex hormone-binding globulin, plasma testosterone, waist circumference, lipid profile, blood pressure, older men, treatment safety
- MeSH terms
- Aged, Humans, Hypogonadism, Erectile Dysfunction, Male, Middle Aged, Safety, Sexual Behavior, Testosterone, Metabolic Syndrome, Testosterone Congeners
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