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Cited by 46Hormonal and reproductive studiesSexual function and dysfunction studiesAdrenal Hormones and Disorders

Androgens and sexual function: a placebo-controlled, randomized, double-blind study of testosterone vs. dehydroepiandrosterone in men with sexual dysfunction and androgen deficiency

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Morales, Alvaro, Black, Angela, Emerson, Laurel, Barkin, Jack, Kuzmarov, Irwin, Day, Andrew·2009·The Aging Male
DOI 10.3109/13685530903294388
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Abstract

PURPOSE: Supplemental administration of androgens has been advocated for men with sexual dysfunction (SD) and hypoandrogenism. The preponderance of evidence indicates that most delivery forms of testosterone (T) are effective but the role of dehydroepiandrosterone (DHEA) is controversial. A placebo-controlled, randomized trial of oral androgen (T versus DHEA) supplementation was carried out to determine their efficacy. MATERIALS AND METHODS: Eighty-six men with SD and decreased levels of serum T and/or DHEA, participated in a study receiving oral T undecanoate (OTU) (n = 29) 80 mg twice daily, DHEA (n = 28) 50 mg twice daily, or placebo (n = 29). Outcomes included evaluation of sexual performance by the International Index of Erectile Function (IIEF), the Androgen Deficiency in the Aging Male (ADAM), Aging Male Symtom Scale (AMS), and Global Assessment Questionnaire (GAQ) questionnaires. Biochemical evaluations included measurement of T and DHEA, prolactin, gonadotropins, and PSA. RESULTS: Seventy-nine men completed the study. There were no significant differences in outcomes as assessed by four different instruments: the ADAM, IIEF, AMS, and GAQ in regard to sexual interest or erectile function. Biochemically, a significant increase in serum DHEA between baseline and final visit was documented in the group receiving DHEA. The levels of T, on the other hand, increased insignificantly between entry and final visit in the T cohort. No biochemical changes were observed in the placebo group. Levels of PSA remained stable in all three groups. CONCLUSIONS: This study did not suggest a clinical benefit of OTU or DHEA supplementation in men with hypoandrogenism and SD. The recommended dose of OTU may have been inadequate or poorly absorbed. Increased doses or an alternative T delivery form may result in a different response.

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  • Oral formulations of testosterone fail to improve symptoms of testosterone deficiency and do not raise serum testosterone levels above placebo due to a lack of bioavailability.

    “However, studies suggest that oral formulations of testosterone fail to improve symptoms of testosterone deficiency and do not raise serum testosterone levels above placebo due to a lack of bioavailability with an oral formulation (31).”

    From Non-testosterone management of male hypogonadism: an examination of the existing literature (2020) · cites this paper as [31]

    The Abstract and Discussion report no clinical benefit from the oral testosterone undecanoate (OTU) regimen studied, no significant rise in serum testosterone, and possible inadequate absorption. The claim overgeneralizes those findings to oral testosterone formulations as a whole and treats poor bioavailability as established; the Conclusions attribute the negative result primarily to the chosen OTU formulation and note that other oral testosterone administration has improved sexual function. (LLM, conf=0.89)

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Research works printed but not linked: 22

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Cited by

Sorted by citations

Authors
Morales, A., Black, A., Emerson, L., Barkin, J., Kuzmarov, I., & Day, A.
Affiliations
  • Queen's University (CA)
  • Québec-Océan (CA)
ORCID
Day, Andrew
Venue
The Aging Male
Publisher
Informa UK Limited
Published
2009-11-03
Volume
12
Issue
4
Pages
104-112
ISSN
  • 1368-5538 (ISSN-L)
  • 1473-0790
DOI
10.3109/13685530903294388
OpenAlex
W2073782873
Cited by
46
References
6
Citations by year
2025: 1 · 2024: 4 · 2023: 2 · 2022: 1 · 2021: 1 · 2020: 3 · 2019: 6 · 2018: 5 · 2017: 1 · 2016: 5 · 2015: 4 · 2014: 4 · 2013: 3 · 2012: 4
FWCI
1.45
Type
journal article
Language
en
Open access
Locations
  • The Aging Male (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 › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
Keywords
testosterone undecanoate, dehydroepiandrosterone, androgen deficiency, male sexual dysfunction, erectile function, older men, International Index of Erectile Function, prostate-specific antigen
MeSH terms
Aged, Androgens, Dehydroepiandrosterone, Double-Blind Method, Humans, Male, Middle Aged, Sexual Dysfunction, Physiological, Testosterone, Outcome Assessment, Health Care

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