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Pharmacokinetics, Efficacy, and Safety of a Permeation-Enhanced Testosterone Transdermal System in Comparison with Bi-Weekly Injections of Testosterone Enanthate for the Treatment of Hypogonadal Men
Abstract
The pharmacokinetics, efficacy, and safety of the Androderm testosterone (T) transdermal system (TTD) and intramuscular T enanthate injections (IM) for the treatment of male hypogonadism were compared in a 24-week multicenter, randomized, parallel-group study.Sixty-six adult hypogonadal men (22-65 years of age) were withdrawn from prior IM treatment for 4 -6 weeks and then randomly assigned to treatment with TTD (two 2.5-mg systems applied nightly) or IM (200 mg injected every 2 weeks); there were 33 patients per group.Twenty-six patients in the TTD group and 32 in the IM group completed the study.TTD treatment produced circadian variations in the levels of total T, bioavailable T, dihydrotestosterone, and estradiol within the normal physiological ranges.IM treatment produced supraphysiological levels of T, bioavailable T, and estradiol (but not dihydrotestosterone) for several days after each injection.Mean morning sex hormone levels were within the normal range in greater proportions of TTD patients (range, 77-100%) than IM patients (range, 19 -84%).Both treatments normalized LH levels in approximately 50% of patients with primary hypogonadism; however, LH levels were suppressed to
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“The effects of testosterone on red blood cell formation (hemoglobin and hematocrit) are dose dependent (14, 82, 83) while higher age is also a factor (44).”
From Onset of effects of testosterone treatment and time span until maximum effects are achieved (2011) · cites this paper as [82]
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Metadata
- Authors
- Dobs, A. S.
- Affiliations
- Johns Hopkins University (US)
- ORCID
- Dobs, A. S.
- Venue
- Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 1999-10-01
- Volume
- 84
- Issue
- 10
- Pages
- 3469-3478
- ISSN
- 0021-972X (ISSN-L)
- OpenAlex
- W2148714770
- Cited by
- 381
- References
- 32
- Citations by year
- 2026: 5 · 2025: 2 · 2024: 10 · 2023: 7 · 2022: 9 · 2021: 9 · 2020: 13 · 2019: 11 · 2018: 9 · 2017: 11 · 2016: 11 · 2015: 22 · 2014: 12 · 2013: 12 · 2012: 21
- FWCI
- 8.06
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
- PubMed (publishedVersion)
- Funders
- University of South Florida
- Svenska Läkaresällskapet
- National Institutes of Health
- Medical Research Council
- National Center for Research Resources (5M01 RR 00722, M01RR000722, RR-0003524)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
- Health Sciences › Medicine › Reproductive Medicine › Hypothalamic control of reproductive hormones
- Keywords
- testosterone replacement therapy, male hypogonadism, transdermal testosterone, testosterone enanthate, intramuscular injection, pharmacokinetics, sex hormone levels, LH suppression, estradiol, dihydrotestosterone, gynecomastia, hematocrit, skin irritation, sexual function, depression, hypergonadotropic hypogonadism
- MeSH terms
- Administration, Cutaneous, Adult, Aged, Drug Administration Schedule, Hematocrit, Humans, Hypogonadism, Injections, Intramuscular, Male, Middle Aged, Permeability, Prostate, Testosterone, Treatment Outcome
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