A 6-month observational study of energy, sexual desire, and body proportions in hypogonadal men treated with a testosterone 1% gel.
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SUBMITTER: Pexman-Fieth C
PROVIDER: S-EPMC3956632 | biostudies-literature | 2014 Mar
REPOSITORIES: biostudies-literature
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Project description:ContextA novel formulation of oral testosterone (T) undecanoate (TU) was evaluated in a phase 3 clinical trial.ObjectiveDetermine efficacy, short-term safety, and alignment of new oral TU formulation with current US approval standards for T replacement therapy.DesignRandomized, active-controlled, open-label study.Setting and patientsAcademic and private clinical practice sites; enrolled patients were clinically hypogonadal men 18 to 65 years old.MethodsPatients were randomized 3:1 to oral TU, as prescribed (JATENZO®; n = 166) or a topical T product once daily (Axiron®; n = 56) for 3 to 4 months. Dose titration was based on average T levels (Cavg) calculated from serial pharmacokinetic (PK) samples. T was assayed by liquid chromatography-mass spectrometry/mass spectrometry. Patients had 2 dose adjustment opportunities prior to final PK visit. Safety was assessed by standard clinical measures, including ambulatory blood pressure (BP).Results87% of patients in both groups achieved mean T Cavg in the eugonadal range. Sodium fluoride-ethylenediamine tetra-acetate plasma T Cavg (mean ± standard deviation) for the oral TU group was 403 ± 128 ng/dL (~14 ± 4 nmol/L); serum T equivalent, ~489 ± 155 ng/dL (17 ± 5 nmol/L); and topical T, 391 ± 140 ng/dL (~14 ± 5 nmol/L). Modeling/simulation of T PK data demonstrated that dose titration based on a single blood sample 4 to 6 h after oral TU dose yielded efficacy (93%) equivalent to Cavg-based titration (87%). Safety profiles were similar in both groups, but oral TU was associated with a mean increase in systolic BP of 3 to 5 mm Hg.ConclusionA new oral TU formulation effectively restored T to mid-eugonadal levels in hypogonadal patients.
| S-EPMC7282712 | biostudies-literature
Project description:ObjectivesTestosterone therapy (TTh) is the main treatment for elderly men with hypogonadism. No evidence of the long-term effectiveness of TTh on renal function is reported to date.MethodsIn this study, we evaluated the long-term TTh of testosterone undecanoate (TU) administration on renal function parameters in 496 symptomatic hypogonadal men, with T levels ≤350 ng/dL. The treatment group (T-group) consisted of 312 patients and obtained TU 1000 mg for 12 weeks followed by 6-week intervals and for up to 8 years. The remaining 184 hypogonadal men, who opted against TTh, served as a control group (C-group). The two groups were similar in criteria prior to treatment. We evaluated renal function by calculating serum creatinine, urea, uric acid, and glomerular filtration rate (GFR) according to Mayo Clinic guidelines for 8 years. This study obeys the ethical guidelines of German medical association according to Section 15 of the Professional Code, document for AY- Ref. EK/CH/AU signed on Jun 2015.ResultsDuring the study period, the T-group exhibited lower levels of urea (47.0 ± 11.8 to 34.0 ± 13.9 mg/dL), uric acid (6.57 ± 1.2 to 5.49 ± 1.5 mg/dL), serum creatinine (0.90 ± 0.10 to 1.12 ± 0.9 mg/dL), and higher-level in GFR (87.0 ± 12.9 to 98.0 ± 8.0 mL/min/1.73 m2), which were significant. Alternatively, the C-group exhibited an increase in their serum creatinine (1.16 ± 0.31 to 1.19 ± 0.58 mg/dL), an increase in uric acid (5.54 ± 1.2 to 5.44 ± 1.7 mg/dL), and a decrease in GFR (92.0 ± 20.1 to 87.0 ± 26.1 mL/min/1.73 m2). A total of 25 deaths (7.8%) was recorded in the T-group, among them 11 (44%) were cardiovascular. On the other hand, 28 patients (15.2%) died in C-group and all deaths (100%) were found to cardiovascular causes.ConclusionThe results suggest that long-term TTh could improve renal function in hypogonadal men comparing to slight deterioration observed in patients without intervention. In addition to reduce mortality in cardiovascular patients, almost to the half.
| S-EPMC8387920 | biostudies-literature
Project description:ObjectiveTo assess the relative effects of individual testosterone products among hypogonadal men.DesignSystematic review and network meta-analysis.MethodsWe searched MEDLINE, Embase, Cochrane CENTRAL, and grey literature (25 May 2017) for randomised-controlled trials (RCTs) and non-randomised studies (NRS) that involved hypogonadal men given testosterone replacement therapy (TRT) for ≥3 months. Comparators were placebo, another TRT, or the same product at a different dose. Outcomes were quality of life, depression, libido, erectile function, activities of daily living and testosterone levels, as well as cardiovascular death, myocardial infarction, stroke, prostate cancer, heart disease, diabetes, serious adverse events, withdrawals due to adverse events and erythrocytosis. RCT data were pooled via meta-analysis and network meta-analysis. Risk of bias was assessed using Cochrane's risk of bias tool (RCTs) andScottish Intercollegiate Guidelines Network (SIGN)50 (NRS).ResultsEighty-seven RCTs and 51 NRS were included. Most were at high or unclear risk of bias, with short treatment duration and follow-up. When compared as a class against placebo, TRT improved quality of life (standardised mean difference (SMD) -0.26, 95% CI -0.41 to -0.11), libido (SMD 0.33, 95% CI 0.16 to 0.50), depression (SMD -0.23, 95% CI -0.44 to -0.01) and erectile function (SMD 0.25, 95% CI 0.10 to 0.41). Most individual TRTs were significantly better than placebo at improving libido (6/10). Only one TRT was better than placebo at improving quality of life, and no individual TRTs improved depression or erectile function. There was no increased risk of adverse events, with the exception of withdrawals due to adverse events with the use of some TRTs.ConclusionDespite a class effect of improving quality of life, depression, erectile function and libido, major improvements were not observed with the use of any individual product. We observed no statistically significant increase in the risk of adverse events; however, longer-term high-quality trials are needed to fully assess the risk of harm.Prospero registration numberCRD42014009963.
| S-EPMC5701987 | biostudies-literature
Project description:ContextThe hormonal basis of vasomotor symptoms (VMS) in hypogonadal men is incompletely understood.ObjectiveTo determine the contributions of testosterone and estradiol deficiency to VMS in hypogonadal men.DesignTwo randomized trials were conducted sequentially between September 2004 and April 2011. Controls were recruited separately.SettingA single-site academic medical center.ParticipantsHealthy men ages 20-50, with normal serum testosterone levels.InterventionCohort 1 (n = 198, 81% completion) received goserelin acetate every 4 weeks to suppress gonadal steroids and were randomized to placebo or 1.25, 2.5, 5, or 10 g of testosterone gel daily for 16 weeks. Cohort 2 (n = 202, 78% completion) received the same regimen as cohort 1 plus anastrozole to block aromatization of testosterone. Controls (n = 37, 89% completion) received placebos for goserelin acetate and testosterone.Main outcome measuresIncidence of visits with VMS. This was a preplanned secondary analysis.ResultsVMS were reported at 26% of visits in cohort 1, and 35% of visits in cohort 2 (P = .02), demonstrating an effect of estradiol deficiency. When adjacent estradiol level groups in cohort 1 were compared, the largest difference in VMS incidence was observed between the 5-9.9 and 10-14.9 pg/mL groups (38% vs 16%, P < .001). In cohort 2, the 10-g testosterone group differed significantly from placebo (16% vs 43%, P = .048) after adjustment for small differences in estradiol levels, indicating that high testosterone levels may suppress VMS.ConclusionsEstradiol deficiency is the key mediator of VMS in hypogonadal men. At high levels, testosterone may have a suppressive effect.
| S-EPMC5010571 | biostudies-literature
Project description:BackgroundSeveral recent journal articles report that D-chiro-inositol (DCI), primarily known as insulin second messenger, influences steroidogenesis. In particular, new evidence is arising on DCI ability to regulate aromatase expression and testosterone biosynthesis. In this regard, DCI administration could represent a good therapeutic opportunity in case of reduced levels of testosterone. Older men generally have lower testosterone concentrations than younger men, and recent randomized controlled trials have examined whether testosterone treatment might improve health outcomes in this age group. There is limited information about the safety of testosterone replacement therapy in these men, hence DCI could represent an interesting alternative for future trials. Therefore, this study aims to evaluate the effect of DCI treatment on testosterone levels in older male patient.ResultsTen older men with basal low testosterone levels were enrolled in this study. Patients took 600 mg of DCI, two-times per day, for 30 days. We evaluated hormonal and glycaemic parameters, weight, waist circumference, and Body-Mass Index at baseline (T0) and after 30 days (T1). Finally, all patients also filled in the standardized International Index of Erectile Function questionnaire and performed the Handgrip test at T0 and T1. Men receiving DCI showed increased androgen and reduced oestrogen concentrations, and improved glycaemic profiles. DCI was also associated with reduced weight, Body-Mass Index, waist circumference, and improved grip strength and self-reported sexual function. All these effects led to the improvement of sexual function and physical strength.ConclusionsIn this pilot study, DCI treatment improved the levels of testosterone and androstenedione at the expense of oestrogens in elder men with low basal levels of these hormones without adverse effects.Trial registrationClinicaltrials.gov: D-chiroinositol Administration in Hypogonadal Males, NCT04708249.
| S-EPMC8588714 | biostudies-literature
Project description:ObjectiveTo investigate the role of baseline gonadotropins in predicting the biochemical response to clomiphene citrate (CC) treatment.MethodsWe conducted a retrospective review of data from hypogonadal men treated with CC in 2 high-volume fertility centers between 2013 and 2018. Patient age, body mass index, and baseline hormones (follicle stimulating hormone [FSH], luteinizing hormone [LH], and total testosterone [TT]) were obtained. Response to treatment was measured as changes in TT levels within 6 months of initiating CC treatment. Linear regression models adjusted for age, body mass index, and time on CC therapy were fitted to assess the associations between baseline LH and FSH levels with treatment response.ResultsA total of 332 men with mean ± standard deviation age of 36.2 ± 8.2 years were included. Median time to initial follow-up was 6 weeks (25th-75th interquartile range [IQR]: 4-9 weeks). TT levels increased significantly on CC treatment (mean change: 329.2 ng/dL, 95% CI: 307.4-351.0) with 73% of men having at least 200 ng/dL increase over baseline TT levels. In univariable linear regression models, only age was significantly associated with TT response. Neither the baseline LH nor FSH significantly predicted TT response in linear regression models.ConclusionCC treatment results in significant increases in testosterone levels in most men. Baseline gonadotropins are not strong predictors for treatment response to CC. Adequate biochemical response with CC trial can be expected in most patients with normal or slightly elevated baseline gonadotropin levels.
| S-EPMC7749702 | biostudies-literature
Project description:PURPOSE:To investigate the association of erectile dysfunction (ED), premature ejaculation (PE), and chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) in men with late-onset hypogonadism (LOH). MATERIALS AND METHODS:We reviewed the data of 408 enrolled men between January 2014 and January 2019. All participants completed the Androgen Deficiency in the Aging Male (ADAM), international index of erectile function-5 (IIEF-5), National Institutes of Health chronic prostatitis symptom index (NIH-CPSI), and premature ejaculation diagnostic tool (PEDT) questionnaires. Participants were divided by ADAM positive (ADAM+: Group 1) and ADAM negative (ADAM-: Group 2). RESULTS:Total of 289 subjects were in Group 1 and 119 were in Group 2. The mean age was 53.8±7.8 years. The mean total testosterone was 4.8±1.2 ng/dL and showed no differences between the groups (p=0.839). In Groups 1 and 2, ED (IIEF?21) was identified in 233 (80.6%) versus 37 (31.1%), respectively (p<0.001). The prevalence of PE (PEDT?9) was 112 (38.7%) versus 13 (10.9%) in Groups 1 and 2, respectively (p<0.001). However, PE (intravaginal ejaculation latency time<5 minutes) showed no differences between the groups (p=0.863). The incidence of chronic prostatitis (NIH-CPSI pain score?4) showed significant differences with 49 (17.0%) versus 8 (6.7%) in Groups 1 and 2, respectively (p=0.007). IIEF-5 total score showed the significantly highest negative correlation (r=-0.313, p<0.001). CONCLUSIONS:Those who complained of LOH symptoms and positive results in the ADAM questionnaire need to be assessed concurrently with the above questionnaires. This could aid useful to detect of ED, PE, and chronic prostatitis co-occurrence.
| S-EPMC7076313 | biostudies-literature
Project description:To determine whether favorable changes to lean tissue mass (LTM), resting energy expenditure (REE), and testosterone (T) that occurred with 12 months of physiological testosterone replacement therapy (TRT) were retained 6 months after discontinuing treatment.Prospective, open-label, controlled drug intervention trial.Metropolitan area hospitals.Eugonadal (n = 11) and hypogonadal (n = 13) men with chronic spinal cord injury (SCI).Hypogonadal subjects received a 5 or 10 mg transdermal T patch daily for 12 months, with adjustment of the dose to normalize the serum T concentration; TRT was discontinued after 12 months (TRT-12M) and subjects were followed for an additional 6 months and re-evaluated (Post-TRT). Total body dual energy X-ray absorptiometry and blood draws were performed at baseline (BL) prior to TRT, TRT-12M, and Post-TRT. Eugonadal subjects did not receive treatment and were evaluated at comparable time points.There were no significant differences between groups prior to TRT at BL for any of the study endpoints. In the hypogonadal group, a significant increase in LTM was observed from BL to TRT-12M (50.2 ± 7.4 vs. 52.9 ± 6.8 kg, P < 0.01), which persisted Post-TRT compared to BL (52.2 ± 7.8 kg, P < 0.05). The increase in REE from BL to TRT-12M (1283 ± 246 vs. 1410 ± 250 kcal/day) was also retained at Post-TRT (1393 ± 220 kcal/day). These sustained improvements in LTM and REE after termination of anabolic hormonal therapy may be associated with persistent beneficial effects on health and physical function of hypogonadal men with chronic SCI.
| S-EPMC4293532 | biostudies-literature
Project description:Testosterone replacement therapies have been shown to increase blood pressure (BP) in hypogonadal men. We studied the effects of a new formulation of testosterone undecanoate (Kyzatrex™) on ambulatory blood pressure (ABP) and heart rate, in 155 men with hypogonadism (mean age, 50.5 years, 76.8% white, 36.1% on antihypertensive therapy). The ABP, heart rate and clinical assessments were obtained at baseline and following 120 and 180 days of therapy. Mean changes from baseline in 24-h ambulatory systolic BP of 1.7 mmHg (95% CI, 0.3, 3.1) at day 120 and 1.8 mmHg (95% CI, 0.3, 3.2) at day 180 were observed post-treatment. For those men on antihypertensive drug therapy, increases in mean 24-h systolic BP were greater than those not taking antihypertensive drugs (3.4 vs 0.7 mmHg at day 120 and 3.1 vs 1.0 mmHg at day 180, respectively). Changes from baseline in 24-h diastolic BP and heart rate at day 120 were smaller (<1 mmHg and <1 beat/min, respectively). There were no relationships observed between testosterone concentration or hemoglobin levels with ABP. Multivariable analyses showed that baseline ambulatory BP and antihypertensive therapy were significantly correlated with BP changes. These data demonstrate small increases in ambulatory BP following 120 days on this oral testosterone undecanoate with no further changes at 180 days. Changes in ambulatory BP were minimal in patients not taking antihypertensive therapy.
| S-EPMC8678838 | biostudies-literature
Project description:BackgroundA novel formulation of oral testosterone undecanoate (TU) was studied in a long- and short-term phase III trial to evaluate safety and efficacy.MethodsHypogonadal men (age 18-65 years; two morning serum testosterone (T) <300 ng/dl with signs/symptoms) were recruited into a 365 day (trial I) or 105 day (trial II), randomized, multicenter trial. Patients were randomized 1:1 to oral TU (n = 161) or T-gel (n = 160) in trial I, and 3:1 to oral TU, twice daily (BID) JATENZO® (n = 166) or a topical T product [Axiron® (n = 56)] in trial II. Dose adjustments were based on average T concentrations (Cavg). Efficacy was assessed based on T levels, body composition and bone density. Safety was assessed by standard clinical measures.ResultsOral TU efficacy (% of patients with eugonadal T Cavg) was 84% (serum Cavg = 628 ± 343 ng/dl) and 87% (serum T equivalent Cavg ≈ 489 ± 155 ng/dl) in trials I and II, respectively. Oral TU significantly (p <0.0001) improved all Psychosexual Daily Questionnaire parameters in trials I and II. In trial I, lean mass increased 3.2 ± 2.7 kg and fat decreased by 2.4 ± 3.6 kg (both p <0.0001) and bone density improved in hip (+0.012 ± 0.0225 g/cm2) and spine (+0.018 ± 0.0422 g/cm2) after 365 days (both p <0.0001). Oral TU-associated adverse effects were consistent with other T-replacement therapies but oral TU patients experienced a greater number of mild gastrointestinal adverse effects. Oral TU subjects in both studies exhibited an increase in mean systolic blood pressure of about 3-5 mmHg. Oral TU was not associated with liver toxicity nor did it cause an elevation in high-sensitivity C-reactive protein or lipoprotein-associated phospholipase A2 (cardiovascular safety biomarkers) after 365 days of therapy.ConclusionA new oral TU formulation was safe and effective and represents a significant therapeutic advance for the treatment of appropriate hypogonadal men.
| S-EPMC7328356 | biostudies-literature