TU Group Research Articles

(394) Effects of Age, Body Mass Index (BMI) and Diabetic Status on Testosterone Levels, Testosterone Dosing and Safety in Hypogonadal Men Treated with an Oral Testosterone Undecanoate (JATENZO)

Abstract Introduction A novel oral testosterone replacement therapy (TRT), testosterone undecanoate (TU, JATENZO) has been shown in 1- and 2-year studies to have durable efficacy and safety. Hypogonadal men are heterogeneous with respect to age, body mass index (BMI), and diabetic status. These factors have been shown to affect the hypothalamic-pituitary-gonadal axis. Objective The purpose of this study is to investigate the role of baseline age, BMI, and diabetic status on change in T levels, final TU dose, and safety. Methods Hypogonadal men, ages 18 – 65 y/o, were recruited into a randomized, open-label, multicenter, dose-titration trial. 222 subjects were randomized to BID TU (n = 166) or testosterone gel (n = 56). Subjects had dose adjustments based on plasma T levels (Cavg). Safety was assessed by standard clinical measures. Post hoc safety, efficacy, and dosing analyses were conducted on subjects who were stratified by age, BMI, and diabetes status. The age groups were <= 44 y/o, 45 – 54 y/o, and => 55 y/o; the BMI groups were < 30 kg/m^2, 30 – 35 kg/m^2, and > 35 kg/m^2; and the subjects were grouped as non-diabetic, pre-diabetic, or diabetic. Results Overall, serum total T Cavg for the oral TU group was 489 ± 12.6 ng/dL (mean ± SE). For all groups, the mean total T was in the eugonadal range. Age, BMI, or diabetes status did not affect key efficacy variables, such as total T or calculated free T, nor key safety variables, such as hematocrit, PSA, liver transaminases, systolic BP, diastolic BP, HDL-C, or LDL-C. There were no differences in the final TU dose among the age categories. In contrast, the final TU dose was significantly different among BMI categories (p=0.0003), and the diabetic status (p < 0.0001). The higher BMI groups need a significantly higher oral TU dose. Those in the pre-diabetic or diabetic groups needed a significantly higher dose than the non-diabetic group. Because the pre-diabetic and diabetic groups had significantly higher BMI, it is difficult to determine if it was diabetes status or BMI that influenced the final dose [baseline BMI: non-diabetic 30.5 ± 0.52 (mean ± SEM), pre-diabetic 32.7 ± 0.54 (p = 0.003 vs the non-diabetic group), diabetic 32.5 ± 0.56 (p = 0.0175 vs the non-diabetic group)]. BMI had a greater effect on the final dose in the non-diabetic group, and its effect appeared to decrease in the pre-diabetic and diabetic groups. See figure for the final mean doses. Although the final total T values were in the eugonadal range, there was also a significantly smaller change from baseline in total T comparing non-diabetics to diabetics (p=0.0042). Conclusions Regardless of age, BMI, or diabetes status, eugonadal total T levels were achieved in men administered oral TU. Age did not influence the final dose. In contrast, BMI and diabetes status influenced the final dose. Patient characteristics (BMI and diabetic status) may guide dosing of testosterone replacement with oral testosterone undecanoate to optimize T levels. Disclosure Yes, this is sponsored by industry/sponsor: Clarus Therapeutics Clarification Industry initiated, executed and funded study Any of the authors act as a consultant, employee or shareholder of an industry for: Clarus Therapeutics.

MP61-09 PATIENT-REPORTED OUTCOMES OF A RANDOMIZED CONTROLLED TRIAL COMPARING SUPRAUMBILICAL VERSUS TRANSUMBILICAL CAMERA PORT IN ROBOTIC ASSISTED LAPAROSCOPIC PROSTATECTOMY

You have accessJournal of UrologyCME1 Apr 2023MP61-09 PATIENT-REPORTED OUTCOMES OF A RANDOMIZED CONTROLLED TRIAL COMPARING SUPRAUMBILICAL VERSUS TRANSUMBILICAL CAMERA PORT IN ROBOTIC ASSISTED LAPAROSCOPIC PROSTATECTOMY Ryuta Tanimoto, Shota Inoue, Yuho Sano, Satoko Kamada, Kenji Sugino, and Katsumi Sasaki Ryuta TanimotoRyuta Tanimoto More articles by this author , Shota InoueShota Inoue More articles by this author , Yuho SanoYuho Sano More articles by this author , Satoko KamadaSatoko Kamada More articles by this author , Kenji SuginoKenji Sugino More articles by this author , and Katsumi SasakiKatsumi Sasaki More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003319.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Supraumbilical camera port (SU) has generally been used in robotic assisted laparoscopic prostatectomy (RALP). Transumbilical camera port (TU) may have cosmetic advantages. In this study, we compared the patient-reported outcomes including cosmetic outcomes, postoperative pain and QOL. METHODS: This study was registered with UMIN-Clinical Trials Registry (protocol ID: UMIN000035259). Between January 2019 and February 2022, 98 patients with localized prostate cancer were enrolled in this study and randomized to SU and TU group (n=50, 48, respectively) based on prostate volume, Gleason score and BMI. In SU group, camera port was inserted through a 12 mm midline incision at 2 cm above umbilicus with Veress needle access, and in TU group, through the umbilicus with Hasson open technique. Body image questionnaire (BIQ), cosmetic scale (CS) on postoperative day (POD) 7, pain score (numeric rating scale; NRS) on POD 1 and 7 and QOL questions (MOS 36 Item short form health survey; SF-36) in postoperative month 3 were collected and compared between the groups. RESULTS: Demographic data and clinical outcomes were comparable between both groups. BIQ (8-44: 8-least satisfied, 44-most satisfied; median, SU vs. TU, 33 vs. 35, p = 0.2254) and Cosmetic Score (2-24: 2-least satisfied, 24-most satisfied; median, SU vs. TU, 17 vs. 18, p = 0.2743) were similar in both groups. NRS on POD 1 (0-10: 0-no pain, 10-worst pain; median (IQR), SU vs. TU, 3 (2 - 4) vs. 3 (2.25 - 5), p=0.0165) was significantly worse in the TU group (Figure. 1), but NRS on POD 7 (median (IQR), SU vs. TU, 0 (0 - 1) vs. 1 (0 - 1), p=0.5252) was not. SF-36 (22-least satisfied, 100-most satisfied; SU vs. TU, 77.6 vs. 80.4, p=0.4035) was similar in both groups. CONCLUSIONS: Patients who underwent RALP with TU did not report cosmetic advantage compared to patients with SU, but they reported significantly worse pain on POD 1. The port placement in RALP should be considered based on not only cosmetic outcomes but postoperative pain. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e855 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ryuta Tanimoto More articles by this author Shota Inoue More articles by this author Yuho Sano More articles by this author Satoko Kamada More articles by this author Kenji Sugino More articles by this author Katsumi Sasaki More articles by this author Expand All Advertisement PDF downloadLoading ...

Exogenous testosterone alleviates cardiac fibrosis and apoptosis via Gas6/Axl pathway in the senescent mice.

Androgen has been implicated in aging-related cardiac remodeling, but its precise role in aging heart remains controversial. We aimed to investigate the role of testosterone in the development of aging-related cardiac remodeling and the mechanisms involved. Wild type and Axl knockout mice (Axl-/-) were randomized into three groups: the young group (n = 30, 3 months old), the aging group (n = 30, 18 months old), the testosterone undecanoate treatment group (TU, n = 30, 18 months old). Mice in the TU group were given testosterone undecanoate (39 mg/kg) by subcutaneous injection on the back at fifteen-months-old, once a month, a total of three times. The old group received solvent reagent (corn oil) by the same method. The aging mice exhibited a decrease in serum testosterone, and Gas6 levels and an increase in apoptosis, and manifested cardiac fibrosis. Testosterone injection to wild type mice increased the levels of testosterone and Gas6 in serum and decreased cardiac apoptosis and fibrosis. Axl-/-mice receiving testosterone injection exhibited no obvious improvement in cardiac remodeling although the levels of testosterone and Gas6 in serum elevated. These data indicated that testosterone replacement therapy (TRT) alleviates cardiac fibrosis and apoptosis, at least in part by enhancing Gas6 expression. Moreover, deletion of Axl disables testosterone, which indicated that Axl is an important downstream regulator of testosterone. TRT would improve aging-related cardiac remolding via Gas6/Axl signaling pathway, implicating its therapeutic potential to treat aging-related heart disease.

Effectiveness and Safety of Polydioxanone Thread-Embedding Acupuncture as an Adjunctive Therapy for Patients with Chronic Nonspecific Neck Pain: A Randomized Controlled Trial.

To evaluate the effectiveness and safety of treatment with thread-embedding acupuncture (TEA) using polydioxanone in addition to usual care for patients with chronic nonspecific neck pain (CNP) compared with treatment with usual care alone. A single-center, assessor-blinded, two-armed randomized controlled trial was performed. One hundred and six outpatients with CNP were randomly allocated into the TEA plus usual care (TU) group or the usual care (UC) group in a 1:1 ratio. TEA treatments in the neck region were provided once a week for 4 weeks, and usual care, as needed, was allowed. The primary outcome was the mean Neck Pain and Disability Scale (NPDS) score. Secondary outcomes included clinical relevance measured by using the clinically important difference (CID), pressure pain threshold (PPT), Hospital Anxiety and Depression Scale (HADS), EuroQol-5 Dimension (EQ-5D), and patient global impression of change (PGIC). Participants were assessed at baseline and at weeks 3, 5, and 9. Statistical analyses included analysis of covariance with baseline score as a covariate. The TU group showed significant improvement in NPDS scores compared with the UC group (adjusted group difference, week 5: 13.74 [95% confidence interval: 7.57-19.90]; p < 0.0001 and week 9: 17.46 [11.15-23.76]; p < 0.0001). The proportion of patients with a decrease on the NPDS score of ≥11.5 points (minimal CID) was significantly higher in the TU group at weeks 5 and 9 than in the UC group. At weeks 5 and 9, significant differences were observed on the anxiety/depression subscale of HADS, EQ-5D, and PGIC between the two groups, but not the PPTs at three sites. Temporary stiffness was observed after TEA treatment, but no serious adverse events occurred. The results suggest that polydioxanone TEA is a safe and clinically beneficial adjunctive treatment for patients with CNP.

Harsh Parenting and Violence Against Children: A Trial with Ultrapoor Families in Francophone West Africa

Few culturally congruent interventions are available to reduce abusive practices in families living in abject poverty in francophone West Africa. This study tests the effects of economic intervention—alone and in combination with a family-focused component—on parenting outcomes and children’s reports of violence in rural Burkina Faso. Female caregivers and their 10- to 15-year-old children from 360 ultrapoor families were recruited to participate in a parallel cluster randomized control trial with 3 study arms: the waitlist (control) group, the economic intervention group (Trickle Up [TU]), and the economic intervention plus family coaching group (TU+). Effects were tested using repeated-measures mixed-effects regressions. At 12 months from baseline, caregivers from the TU+ group reported a reduced use of harsh discipline compared to the control group (Cohen’s d = –0.57, p = .001) and the TU group (d = –0.48, p = .001). Changes were maintained at 24 months. TU+ caregivers also expressed more supportive parenting attitudes at 12 months compared to the control group (d = 0.39, p = .022) and the TU group (d = 0.55, p = .001). Compared to TU caregivers, caregivers in the TU+ group also reported a better quality of child–parent relationship (d = 0.40, p = .041). At 24 months, children in the TU+ group had lower odds of experiencing physical (odds ratio = 0.35, p = .050), 95% confidence interval [0.12, 1.00], and emotional (odds ratio = 0.52, p = .033), 95% confidence interval [0.28, 0.95], violence at home, compared to the control group children. The evidence suggests that involving all family members in sessions on child protection in addition to economic strengthening strategies can foster supportive parenting environments and reduce family violence among children living in ultralevel poverty in West Africa.

An Integrated Approach to Increasing Women's Empowerment and Reducing Domestic Violence: Results of a Cluster-Randomized Controlled Trial in a West African Country.

This is the first experimental study testing the effects of an economic intervention alone and in combination with a family-focused component, on women's empowerment status and family violence in Burkina Faso. The three-arm cluster randomized controlled trial with baseline and one-year follow-up included 360 ultra-poor married women from 12 villages. Villages were randomized to the three study arms: economic intervention for women (Trickle Up/TU), a combination of economic intervention and family coaching (Trickle Up Plus), and waitlist (Control arm). Analysis utilized repeated-measures mixed effects regressions. Compared to the control group, there was a significant improvement in both the TU arm and the TU Plus arm in women's financial autonomy and in quality of marital relationships. In addition, women in both intervention arms reported a significant reduction in emotional spousal violence in the past year, with the effect size greater for the combined intervention (TU group OR=0.28, 95% CI 0.10,0.82 p=0.02 and TU+ group OR=0.19, 95% CI 0.06,0.64, p=0.007). Economic intervention shows benefits that go beyond changes in financial wellbeing and may increase women's status and improve family relationships. Integrating psychosocial components with economic strategies may be more effective for improving women's empowerment status in West Africa.

Abdominal Exploration in Neonates Using Transumbilical Exposure Compared with Transverse Laparotomies.

The vertical transumbilical incision (TU) technique during neonatal abdominal exploration involves dissection and ligation of umbilical vessels, which allow access to all quadrants of the abdomen and complete bowel evisceration with minimal violation to the anterior abdominal wall. We compared patient characteristics and outcomes for neonates undergoing TU with standard transverse exploration. A single-center retrospective review of neonates who underwent abdominal exploration between January 2010 and September 2015 was conducted after obtaining Institutional Review Board approval. Data included patient demographics, indication for operative intervention, operative details, complications, including incisional hernias, and long-term outcomes. There were 88 neonates under 4 months of age who underwent abdominal exploration, with a median age of 5.5 ± 17 days and a median gestational age of 32.8 ± 16 weeks. Exploration was emergent in 38 patients (43%) and 49 (56%) required ostomy formation. A transverse incision (TV) was used in 30 patients and a TU in 58 patients. Both groups had similar postoperative complication rates; 27 (47%) in the TU group and 11 (36%) in the TV group, P = .51. Median length of follow-up in the TU group was 5.1 ± 18 months and 6.2 ± 16 months in the TV group, P = .48. The TU group had 4 incisional/umbilical hernias (7%), none have required repair. TUs for abdominal explorations in neonates have similar outcomes as the standard TV while preserving the integrity of the anterior abdominal wall.

Youyou Tu: significance of winning the 2015 Nobel Prize in Physiology or Medicine.

Youyou Tu, a female scientist at the China Academy of Traditional Chinese Medicine in Beijing, is the first Chinese winner of the Nobel Prize in Physiology or Medicine. Based on the study of recipes which had been used for thousands of years to treat fever, Tu's group discovered that the plant artemesia annua, sweet wormwood, showed substantial inhibition of rodent malaria parasites. Her achievement and experience have inspired other researchers and emphasized the development of traditional Chinese medicine. Her award has led to a heated discussion about scientific research investment, fair treatment of research staff, and intellectual property right (IPR) protection in China.

Prospective randomized clinical trial comparing laparoscopic cholecystectomy and hybrid natural orifice transluminal endoscopic surgery (NOTES) (NCT00835250)

Natural orifice transluminal endoscopic surgery (NOTES) is a technique still in experimental development whose safety and effectiveness call for assessment through clinical trials. In this paper we present a three-arm, noninferiority, prospective randomized clinical trial of 1 year duration comparing the vaginal and transumbilical approaches for transluminal endoscopic surgery with the conventional laparoscopic approach for elective cholecystectomy. Sixty female patients between the ages of 18 and 65 years who were eligible for elective cholecystectomy were randomized in a ratio of 1:1:1 to receive hybrid transvaginal NOTES (TV group), hybrid transumbilical NOTES (TU group) or conventional laparoscopy (CL group). The main study variable was parietal complications (wound infection, bleeding, and eventration). The analysis was by intention to treat, and losses were not replaced. Cholecystectomy was successfully performed on 94% of the patients. One patient in the TU group was reconverted to CL owing to difficulty in maneuvering the endoscope. After a minimum follow-up period of 1 year, no differences were noted in the rate of parietal complications. Postoperative pain, length of hospital stay, and time off from work were similar in the three groups. No patient developed dyspareunia. Surgical time was longer among cases in which a flexible endoscope was used (CL, 47.04 min; TV, 64.85 min; TU, 59.80 min). NOTES approaches using the flexible endoscope are not inferior in safety or effectiveness to conventional laparoscopy. The transumbilical approach with flexible endoscope is as effective and safe as the transvaginal approach and is a promising, single-incision approach.

Effects of testosterone supplementation on markers of the metabolic syndrome and inflammation in hypogonadal men with the metabolic syndrome: the double‐blinded placebo‐controlled Moscow study

Men with the metabolic syndrome (MetS) have low plasma testosterone (T) levels. The aim of this study was to establish whether the normalization of plasma T improves the features of the MetS. A randomized, placebo-controlled, double-blinded, phase III trial of 184 men suffering from both the MetS and hypogonadism. One hundred and eighty-four men, aged 35-70, with the MetS and hypogonadism (baseline total T level <12·0 nm or calculated free T level <225 pm.), recruited in the outpatient andrology and urology clinic, Research Center for Endocrinology in Moscow, Russia. Treatment for 30 weeks with either parenteral T undecanoate (n = 113; TU; 1000 mg IM) or placebo (n = 71), administered at baseline, and after 6 and 18 weeks. One hundred and five (92·9%) men receiving TU and 65 (91·5%) receiving placebo completed the trial. Body weight, body mass index (BMI), waist circumference (WC), hip circumference, waist-to-hip ratio, insulin, leptin, glucose, cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, C-reactive protein (CRP), interleukin-1-beta (IL-1β), interleukin-6 (IL-6), interleukin-10 (IL-10) and tumour necrosis factor-alpha (TNF-α). There were significant decreases in weight, BMI and WC in the TU vs placebo group. Levels of leptin and insulin also decreased, but there were no changes in serum glucose or lipid profile. Of the inflammatory markers, IL-1β, TNF-α and CRP decreased, while IL-6 and IL-10 did not change significantly. Thirty weeks of T administration normalizing plasma T in hypogonadal men with the MetS improved some components of the MetS and a number of inflammatory markers.

SEM-EDS and biomechanical evaluation of implants with different surface treatments: an initial study

Aim Alterations in implant surfaces can affect periimplant bone formation and shorten the healing time. The goal of the present study was a comparative scanning electron microscopy (SEM)/energy dispersive spectrometry (EDS) and biomechanical evaluation of implants subjected to different surface treatments. Materials and Methods Four implant surfaces were analyzed in the present study: machined commercial implants (TU); porous-surfaced commercial implants blasted with Al2O3 microspheres and acid-etched (TJA); laser beam-irradiated experimental implants (Laser) and laser beam-irradiated experimental implants with hydroxyapatite coating (HA). One sample for each surface underwent pre-surgery SEM / EDS analysis. Thirty- two implants (8 for each surface treatment) were then inserted into the tibia of 4 rabbits. After 8 weeks, the animals were euthanized and the implants retrieved by reverse torque and processed for post-surgery SEM / EDS analysis. Results HA implants presented higher removal torque values when compared to Laser, TJA and TU groups. Post-surgery SEM micrographs clearly showed bone formation on all the examined surfaces; however, in the TU group bone covered only some areas of the implant surface, while in TJA, Laser and HA groups the entire implant surfaces were overlaid by newly formed bone. EDS analysis supported the results obtained by SEM and removal torque, showing that concentration of Ca and P increased from TU to TJA, Laser and HA implants. Conclusions Implants with surfaces modified by laser beam with or without apatite coating showed more promising results.

Distinctive E‐cadherin and epidermal growth factor receptor expression in metastatic and nonmetastatic head and neck squamous cell carcinoma

The authors investigated whether coexpression and localization of E-cadherin (E-cad) and epidermal growth factor receptor (EGFR) had predictive and/or prognostic correlations with lymph node metastasis and/or survival in patients with squamous cell carcinoma of the head and neck (SCCHN). Immunohistochemistry (IHC) of archival tissue was performed to measure expression of EGFR and E-cad in surgical specimens of SCCHN (n = 143) that included primary tumors (PTs) with positive lymph nodes (Tu+Met) and their paired lymph node metastases (LnMet), PTs with negative lymph nodes (Tu(-Met)), and benign tissue biopsies as normal controls. IHC staining was quantified as a weighted index and as the ratio of membrane to cytoplasmic staining. Correlative expression between EGFR and E-cad also was examined in SCCHN cell lines by immunoblotting and immunofluorescence analyses. Three distinct expression patterns of EGFR and E-cad were observed. Membrane localization of E-cad was significantly lower in the Tu+Met group than in the Tu(-Met) group (P = .01) and was associated inversely with lymph node status (P = .009). Wilcoxon analysis of the combined markers demonstrated that expression and/or membrane localization of EGFR and E-cad were correlated with disease-free survival and overall survival in patients with SCCHN. The study of SCCHN cell lines demonstrated that cells with positive but low EGFR expression and with negative E-cad expression were relatively resistant to the EGFR tyrosine kinase inhibitor erlotinib. The current study suggested that examining not only the expression but also the localization of EGFR and E-cad simultaneously may have clinical relevance in predicting lymph node metastasis, patient survival, and response to EGFR-targeted therapy in patients with SCCHN.

Effects of thyroxine and thiourea on the metamorphosis of coral trout grouper Plectropomus leopardus

: The contribution of the thyroid hormone to the metamorphosis of the coral trout Plectropomus leopardus was examined. Juveniles, aged 35 days, were exposed to thyroxine (T4, 0.1 p.p.m) and thiourea (TU; inhibitor of thyroid hormone synthesis, 30 p.p.m) for 13 days. All the fish in the T4-treated group had completed metamorphosis (second metamorphosis, pigmentation and resorption of fin spines) within three days after the beginning of the experiment (day 3), whereas it took 13 days for this to occur in the control fish. Moreover, the fish in the TU group had not completed metamorphosis even by day 13. Settling behavior was significantly stimulated by T4 treatment, as was the resorption of the dorsal and pelvic fin spines, the reduction of serration on the spines, and the transition of body color into an opaque reddish hue. Fish in the TU group had longer dorsal and pelvic spines, retarded pigmentation and an abnormal black coloration. These results suggest that thyroid hormone accelerates most changes during the second metamorphosis in the coral trout.

Influence of various modes of androgen substitution on serum lipids and lipoproteins in hypogonadal men

We investigated whether the androgen type or application mode or testosterone (T) serum levels influence serum lipids and lipoprotein levels differentially in 55 hypogonadal men randomly assigned to the following treatment groups: mesterolone 100 mg orally daily ([MES] n = 12), testosterone undecanoate 160 mg orally daily ([TU] n = 13), testosterone enanthate 250 mg intramuscularly every 21 days ([TE] n = 15), or a single subcutaneous implantation of crystalline T 1,200 mg ([TPEL] n = 15). The dosages were based on standard treatment regimens. Previous androgen substitution was suspended for at least 3 months. Only metabolically healthy men with serum T less than 3.6 nmol/L and total cholesterol (TC) and triglyceride (TG) less than 200 mg/dL were included. After a screening period of 2 weeks, the study medication was taken from days 0 to 189, with follow-up visits on days 246 and 300. Before substitution, all men were clearly hypogonadal, with mean serum T less than 3 nmol/L in all groups. Androgen substitution led to no significant increase of serum T in the MES group, subnormal T in the TU group (5.7 ± 0.3 nmol/L), normal T in the TE group (13.5 ± 0.7 nmol/L), and high-normal T in the TPEL group (23.2 ± 1.1 nmol/L). 5 α-Dihydrotestosterone significantly increased in all treatment groups compared with baseline. Compared with presubstitution levels, a significant increase of TC was observed in all treatment groups (TU, 14.4% ± 3.0%; MES, 18.8% ± 2.5%; TE, 20.4% ± 3.0%; TPEL, 20.2% ± 2.6%). Low-density lipoprotein cholesterol (LDL-C) also increased significantly by 34.3% ± 5.5% (TU), 46.4% ± 4.1% (MES), 65.2% ± 5.7% (TE), and 47.5% ± 4.3% (TPEL). High-density lipoprotein cholesterol (HDL-C) showed a significant decrease by −30.9% ± 2.8% (TU), −34.9% ± 2.5% (MES), −35.7% ± 2.6% (TE), and −32.5% ± 3.5% (TPEL). Serum TG significantly increased by 37.3% ± 11.3% (TU), 46.4% ± 10.3% (MES), 29.4% ± 6.5% (TE), and 22.9% ± 6.7% (TPEL). TU caused a smaller increase of TC than TE and TPEL, whereas the parenteral treatment modes showed a lower increase of TG. There was no correlation between serum T and lipid concentrations. Despite the return of serum T to pretreatment levels, serum lipid and lipoprotein levels did not return to baseline during follow-up evaluation. In summary, androgen substitution in hypogonadal men increases TC, LDL-C, and TG and decreases HDL-C independently of the androgen type and application made and the serum androgen levels achieved. Due to the extended washout period for previous androgen medication and the exclusion of men with preexisting hyperlipidemia, this investigation demonstrates more clearly than previous studies the impact of androgen effects on serum lipids and lipoproteins. It is concluded that preexisting low serum androgens induce a “male-type” serum lipid profile, and increasing serum androgens further within the male normal range does not exert any additional effects. The threshold appears to be above the normal female androgen serum levels and far below the lower limit of normal serum T levels in adult men. These findings may have considerable implications for the use of androgens as a male contraceptive and for androgen therapy in elderly men.