Effect of Testosterone on Progression From Prediabetes to Diabetes in Men With Hypogonadism

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madman

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Effect of Testosterone on Progression From Prediabetes to Diabetes in Men With HypogonadismA Substudy of the TRAVERSE Randomized Clinical Trial (2024)​

Shalender Bhasin, MB, BS1; A. Michael Lincoff, MD2; Steven E. Nissen, MD2; Kathleen Wannemuehler, PhD3; Marie E. McDonnell, MD4; Anne L. Peters, MD5; Nader Khan, MD6; Michael C. Snabes, MD, PhD6; Xue Li, PhD6; Geng Li, MS3; Kevin Buhr, PhD3; Karol M. Pencina, PhD1; Thomas G. Travison, PhD7,8



Nearly 35% of adults in the US have prediabetes.1 Prediabetes is associated with increased risk of progression to type 2 diabetes, cardiovascular disease (CVD), chronic kidney disease, and all-cause mortality.2-6 Low testosterone levels are associated with an increased risk of prediabetes and type 2 diabetes in men.7-12 Experimental or therapeutic induction of testosterone deficiency in men is associated with increased fat mass, insulin resistance, and type 2 diabetes.13-16

Testosterone replacement therapy (TRT) in men with hypogonadism reduces whole-body and visceral fat mass, increases muscle mass, and improves insulin sensitivity. 17-19 Testosterone-induced increases in muscle mass may secondarily improve metabolic outcomes.20,21
An uncontrolled registry study reported a decrease in hemoglobin A1c level and a lower rate of progression from prediabetes to diabetes in testosterone-treated men than in a separate group of untreated men with hypogonadism.22 However, to our knowledge, a randomized clinical trial of the effects of TRT without concurrent lifestyle intervention on the progression from prediabetes to diabetes in middle-aged and older men with hypogonadism has not been conducted. This issue is clinically important because men with prediabetes and diabetes have a high prevalence of hypogonadism,23,24 and a substantial proportion of men receiving TRT have diabetes or prediabetes. Information on testosterone’s efficacy in preventing progression from prediabetes to diabetes or in inducing glycemic remission would be useful to clinicians and men with hypogonadism who are weighing the potential benefits and risks of TRT.

The Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in HypogonadalMen (TRAVERSE) trial (NCT03518034) evaluated the effect of TRT and placebo on major adverse cardiovascular events (MACE) in men with hypogonadism.25,26 The TRAVERSE Diabetes Study was a prespecified efficacy study nested within the TRAVERSE trial in which the primary aim was to compare the efficacy of TRT and placebo in preventing progression from prediabetes to diabetes in middle-aged and older men with hypogonadism. We hypothesized that TRT for men with hypogonadism and prediabetes would be associated with a significantly lower rate of progression to diabetes. A secondary aim was to assess the efficacy of TRT in inducing glycemic remission among participants with diabetes at baseline. The study also evaluated the effect of TRT on fasting glucose and hemoglobin A1c levels.





Methods

This study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline. The TRAVERSE trial’s design and MACE results have been previously published 25,26 This placebo-controlled randomized clinical trial conducted 316 sites in the US and, from May 23, 2018, to January 19, 2023, enrolled men aged 45 to 80 years with 2 fasting morning testosterone concentrations less than 300 ng/dL (to convert to nmol/L, multiply by 0.0347) measured using liquid-chromatography–tandem mass spectrometry (LC-MS/MS), 1 or more symptoms of hypogonadism, and preexisting CVD or increased risk of CVD.25 Men with contraindications for TRT, such as erythrocytosis, history of prostate cancer, or severe lower urinary tract symptoms, were excluded.25 The trial protocol (Supplement 1) was approved by the participating national and local institutional review boards for human participant research. All participants provided written informed consent. A data and safety monitoring committee reviewed unblinded safety data every 6 months. TRAVERSE site investigators are listed in the eAppendix in Supplement 2.

The protocol for the parent TRAVERSE trial has been previously published. 25 The Diabetes Substudy protocol and statistical analysis plan are included in Supplement 1. The TRAVERSE Diabetes Study was nested within the parent TRAVERSE trial and included 2 subpopulations: those with prediabetes or diabetes at baseline. The participants included in the diabetes substudy met the eligibility criteria for the parent trial. In addition, randomized participants included in the analysis of progression from prediabetes to diabetes had prediabetes defined by a hemoglobin A1c level between 5.7% and 6.4% (to convert to proportion of total hemoglobin, multiply by 0.01) or 1 or more fasting glucose level measurement between 100 and 125 mg/dL (to convert tommol/L, multiply by 0.0555). Secondary analyses of glycemic remission of diabetes included all randomized participants with diabetes at baseline, defined by a hemoglobin A1c level greater than or equal to 6.5% or 2 fasting glucose level measurements greater than 125 mg/dL before randomization, current diagnosis of diabetes, or current use of diabetes medication.

Fasting plasma glucose in samples collected in tubes containing sodium fluoride) and hemoglobin A1c (assayed using ion exchange high-pressure liquid chromatography) levels at baseline and during months 6, 12, 24, 36, and 48 and at the end of the study were measured by LabCorp, Inc. Serum testosterone, dihydrotestosterone, and estradiol levels were measured by LabCorp, Inc, using LC-MS/MS methods certified by the Hormone Standardization Program of the Centers for Disease Control and Prevention.


Race and ethnicity were ascertained by self-report. Race categories included Black or African American, White, and other(American Indian or Alaska Native, Asian, Native Hawaiian, Pacific Islander, and multiracial). Ethnicity categories were Hispanic or Latino and not Hispanic or Latino.





Intervention and Randomization

Patients were randomized 1:1 to receive 1.62% testosterone gel or placebo gel until study completion. Patients were randomized in a 1:1 ratio with stratification for preexisting cardiovascular disease using Interactive Response Technology to receive 1.62% testosterone gel or matching placebo gel until study completion. The participants, the study staff, and those assessing outcomes were blinded. As described previously, 26 testosterone doses were titrated centrally based on serum on-treatment testosterone levels, and hematocrit to maintain serum on-treatment testosterone levels between 350 and 750 ng/dL.




Study Outcomes

The primary endpoint of the TRAVERSE Diabetes Study was the risk of progression from prediabetes to diabetes (defined as hemoglobin A1c level ≥6.5%, initiation of diabetes medication, or 2 consecutive fasting glucose level measurements>125mg/dL) assessed at all available post-randomization time points in participants with prediabetes at baseline. A secondary endpoint was the risk of glycemic remission in participants with diabetes at baseline, defined as hemoglobin A1c level less than 6.5% or 2 consecutive fasting glucose level measurements less than 126 mg/dL without current use of antidiabetic medications. Additionally, changes from baseline in fasting glucose and hemoglobin A1c levels were evaluated separately in men who had prediabetes or diabetes.




Statistical Analyses

End-of-study assessments were completed on January 19, 2023. The intention-to-treat analysis of the primary efficacy endpoint, progression from prediabetes to diabetes, included all randomized participants (full analysis set) who had prediabetes at baseline (statistical analysis plan in Supplement 1). The risk ratio of progression to diabetes in the TRT vs placebo group was estimated by repeated-measures log-binomial generalized estimating equations regression with fixed effects for treatment, visit, treatment-visit interaction, and preexisting CVD and an unstructured working correlation matrix (or compound symmetric where explicitly stated) to account for repeated measures at multiple visits. The estimates of the relative risk associated with TRT compared with placebo, 95% CIs, and an associated generalized score statistic P value testing the null hypothesis of no difference between the TRT and placebo groups across all time points were derived from the model.

The risk ratio of glycemic remission associated with TRT compared with placebo was estimated using a model similar to that used for the primary analysis. Analyses for change from baseline in glucose level, hemoglobin A1c level, body weight, and sex hormones used a linear mixed-effects model controlling for baseline value and preexisting CVD, assuming an unstructured covariance matrix. Sensitivity analyses estimated the intervention effect on progression to diabetes and glycemic remission using a discrete-time proportional hazards regression model27 with event-time intervals based on scheduled visits. Supportive analyses in which follow-up time was censored at 30 and 365 days after the last dose of study medication were also performed.





Results

A total of 5246 individuals were randomized in the TRAVERSE trial.26 After the exclusion of 42 participants with identification numbers attributed to duplicate enrollment, the full analysis set for the present study included 5204 participants, of whom 2,601 were in the TRT group and 2603 were in the placebo group. Among these participants, 1175 had prediabetes (607 were randomized to testosterone and 568 were randomized to placebo) (Figure 1) and 3880 had diabetes (1917 were randomized to testosterone and 1963 were randomized to placebo)

Baseline characteristics were similar between the testosterone- and placebo-treated men who had prediabetes or diabetes (Table). The mean (SD) age of participants with prediabetes was 63.8 (8.1) years, the mean (SD) fasting glucose level was 109.4 (13.8) mg/dL, and the mean (SD) hemoglobin A1c level was 5.8% (0.4%). The mean (SD) age of participants with diabetes was 63.2 (7.8) years, the mean (SD) fasting glucose level was 164.5 (60.3) mg/dL, and the mean (SD) hemoglobin A1c level was 7.6% (1.3%). Of the 5204 total participants, 877 (16.9%) were Black or African American; 848 (16.3%), were Hispanic or Latino; 4353 (83.6%), were not Hispanic or Latino; 4154 (79.8%), White; and 173 (3.3%), other race. The frequency of use of various diabetes medications was similar between the TRT and placebo groups


Of 1175 participants with prediabetes, 1160 (98.7%) were followed up for at least 6 months, 1108 (94.3%) for 1 year, 954 (81.2%) for 2 years, 689 (58.6%) for 3 years, and 285 (24.3%) for 4 years (Figure 1). The mean (SD) follow-up duration was 32.1 (12.2) months and 31.5 (12.4) months in the TRT and placebo groups, respectively. Of 3880 participants with diabetes, 3840 (99.0%) were followed up for at least 6 months, 3666 (94.5%) for 1 year, 3326 (83.4%) for 2 years, 2505 (64.6%) for 3 years, and 1018 (26.2%) for 4 years; mean (SD) follow-up duration was 33.5 (11.9) months and 33.3 (11.9) months in the TRT and placebo groups, respectively.





Progression From Prediabetes to Diabetes

The relative risk of progression from prediabetes to diabetes did not differ significantly between testosterone and placebo groups: 4 of 598 (0.7%) vs 8 of 562 (1.4%) at 6 months, 45 of 575 (7.8%) vs 57 of 533 (10.7%) at 12 months, 50 of 494 (10.1%) vs 67 of 460 (14.6%) at 24 months, 46 of 359 (12.8%) vs 52 of 330 (15.8%) at 36 months, and 22 of 164 (13.4%) vs 19 of 121 (15.7%) at 48 months (omnibus test P = .49 after adjusting for preexisting CVD) (Figure 2). Supportive analyses using the discrete-time proportional hazards regression model showed similar results (hazard ratio, 0.78; 95% CI, 0.58-1.06).




Glycemic Remission Among Those With Diabetes

The risk of glycemic remission among participants with diabetes at baseline did not differ significantly between the testosterone and placebo groups: 7 of 1898 (0.4%) vs 5 of 1942 (0.3%) at 6 months, 78 of 1808 (4.3%) vs 74 of 1858 (4.0%) at 12 months, 82 of 1619 (5.1%) vs 70 of 1617 (4.3%) at 24 months, 64 of 1251 (5.1%) vs 61 of 1254 (4.9%) at 36 months, and 24 of 517 (4.6%) vs 23 of 501 (4.6%) at 48 months (omnibus testP = .95 after adjusting for preexisting CVD) (Figure 3). The discrete-time proportional hazards regression model showed similar results (HR, 1.15; 95% CI, 0.87-1.53).




Fasting Glucose and Hemoglobin A1c Levels and Prespecified Subgroup Analyses

The change from baseline in fasting glucose or hemoglobin A1c (Figure 4) concentrations did not differ between testosterone and placebo groups in participants with either prediabetes or diabetes at baseline. The findings of prespecified subgroup analyses by baseline testosterone level (<250 or ≥250 ng/dL), preexisting CVD (yes or no), self-identified race (Black or African-American or White), and age (<65 or ≥65 years) did not show significant differences between testosterone and placebo groups for either progression from prediabetes to diabetes or glycemic remission (eFigures 1 and 2 in Supplement 2).




Sensitivity Analyses

Of the 877 randomized participants self-identifying as Black or African American, 178 were classified as having prediabetes and 682 as having diabetes at baseline by the standard definition; by the modified definition that did not consider hemoglobin A1c level, 168 had prediabetes and 660 had diabetes. The discrete-time proportional hazards regression model of progression from prediabetes to diabetes (HR, 2.47; 95% CI,0.48-12.76) and glycemic remission (HR, 2.71; 95% CI, 1.07-6.87) using the modified definitions of prediabetes and diabetes yielded results similar to those using the standard definition.

Post hoc sensitivity analyses of the primary and secondary events occurring within 30 days or within 365 days after stopping treatment yielded results similar to those of the primary analyses (eFigures 3 and 4 in Supplement 2).
In men with prediabetes and diabetes at baseline, body weight decreased significantly more in the TRT group than in the placebo group (eTable 1 in Supplement 2).





Hormone Levels and Safety

Serum total testosterone, dihydrotestosterone, and estradiol concentrations increased significantly more in the testosterone-treated men than in the placebo-treated men with prediabetes or diabetes (eTable 2 in Supplement 2). Testosterone replacement therapy was associated with a higher incidence of venous thromboembolism, atrial fibrillation, and acute kidney injury in the parent trial,26 but there did not appear to be any additional between-group differences by diabetes or prediabetes status (eTable 3 in Supplement 2).




Discussion

The TRAVERSE Diabetes Study is, to our knowledge, the largest placebo-controlled randomized clinical trial to date to evaluate the efficacy of TRT without a lifestyle intervention in preventing progression from prediabetes to diabetes in men with hypogonadism and in inducing glycemic remission in men with hypogonadism and diabetes. In this study, TRT was not superior to placebo in preventing progression from prediabetes to diabetes; consistent with these findings, fasting glucose and hemoglobin A1c levels did not change significantly in either group and did not differ significantly between the 2 study groups. These findings were further corroborated by sensitivity analyses using discrete-time proportional hazards regression models in which the events were censored 30 and 365 days after the last dose. The risk of glycemic remission also was similar between testosterone- and placebo-treated participants who had diabetes at baseline; between-group differences in changes in fasting glucose or hemoglobin A1c levels were neither statistically significant nor clinically meaningful, corroborating the findings of no significant effect on glycemic remission. Other, smaller trials of TRT in men with hypogonadism also found no significant improvements in hemoglobin A1c or fasting glucose level.31,32The findings of this study suggest that TRT alone should not be used as a therapeutic intervention to prevent or treat diabetes in men with hypogonadism.

Testosterone’s known effects on body composition and metabolism would be expected to improve insulin sensitivity and retard progression from prediabetes to diabetes. Testosterone treatment increases skeletal muscle mass, reduces whole-body and visceral fat mass,19,33,34, and modestly improves insulin sensitivity.31,32 Muscle is an important regulator of metabolism,35 and testosterone-induced increases in muscle mass might be expected to secondarily improve insulin sensitivity.
Induction of severe testosterone deficiency by administration of a gonadotropin-releasing hormone agonist to healthy men or men with prostate cancer or by cessation of TRT in men with hypogonadism is associated with the development of insulin resistance and an increased risk of diabetes.14-16However, the present study found no meaningful improvements in either fasting glucose or hemoglobin A1c levels. The TRAVERSE participants had mild to moderate testosterone deficiency; it is possible that greater improvements in insulin sensitivity may be observed in men with severe testosterone deficiency. However, most men with hypogonadism receiving TRT today have mild testosterone deficiency.36 Testosterone levels during treatment in this study were lower than in some other testosterone trials; testosterone levels in TRAVERSE were measured 24 hours after gel application, and nadir levels were lower than the 24-hour time-averaged concentrations. In the Testosterone for Diabetes Mellitus (T4DM) trial,37 testosterone treatment plus lifestyle intervention in men with overweight or obesity was associated with a lower incidence of 2-hour glucose level greater than or equal to 200 mg/dL on oral glucose tolerance test compared with lifestyle intervention alone. However, not all men in the T4DM trial had hypogonadism, and testosterone was administered along with a lifestyle intervention that may have augmented the effects of testosterone on muscle and fat mass.38,39 Similar to the findings of the current study, the T4DM trial also did not find significant changes in hemoglobin A1c levels.37

The TRAVERSE participants were selected on the basis of preexisting or increased risk of CVD and had high rates of prediabetes and diabetes at baseline. Epidemiologic studies, surveys of men receiving TRT, and randomized clinical trials have also found a high prevalence of diabetes and prediabetes in men with hypogonadism.24,40,41

Lifestyle modification, metformin, acarbose, pioglitazone, and glucagon-like peptide 1 analogs reduce the incidence of progression from prediabetes to diabetes.42,43 The findings of this study do not support the use of TRT alone to prevent or treat diabetes in men with hypogonadism. The trial’s findings may be useful in weighing the potential benefits of TRT in middle-aged and older men with hypogonadism who have prediabetes or diabetes.





Strengths and Limitations

The TRAVERSE trial has some notable strengths. The participants were required to have 2 fasting morning testosterone level measurements using an LC-MS/MS assay certified by the Hormone Standardization Program of the Centers for Disease Control and Prevention and 1 or more symptoms of hypogonadism in conformity with the Endocrine Society’s guideline.44We used fasting glucose and hemoglobin A1c levels to ascertain prediabetes and diabetes; the combined use of fasting glucose and hemoglobin A1c testing has better predictive value than either test alone for progression to diabetes45 and for assessing glycemic control. It was not deemed to be feasible to perform a 2-hour oral glucose tolerance test given participant burden and cost in the context of a large trial. There is substantial overlap in pathophysiological mechanisms in persons diagnosed with prediabetes or diabetes by any of the 3 tests, although the pathophysiology of hyperglycemia in some individuals diagnosed by oral glucose tolerance test may differ from those diagnosed by fasting glucose or hemoglobin A1c testing.45,46Neither fasting glucose nor hemoglobin A1c levels changed significantly with TRT in men with prediabetes or diabetes, supporting the findings of the primary analyses. Factors other than glucose concentrations can influence hemoglobin A1c levels, especially in Black individuals in the US,30 but sensitivity analyses using only fasting glucose testing confirmed the findings of the primary analyses.

The study has some limitations. The findings should not be extrapolated to men who do not have hypogonadism or to women. The association of testosterone with the risk of diabetes is sexually dimorphic,12 and sex and gender differences in response to testosterone have not been studied. The sample size of the TRAVERSE trial was guided by estimated numbers of MACE, and the sample size of the diabetes substudy was defined by the number of randomized participants who had prediabetes and diabetes at baseline. However, the lack of meaningful change in fasting glucose and hemoglobin A1c levels using more statistically powerful analyses of continuous outcomes supports the findings of the primary and secondary analyses of prespecified binary endpoints.
As reported previously,26 the incidence of early discontinuation of the trial regimen while continuing trial assessments (61.6%) and early withdrawal from the trial and having no further assessments (39.0%) was relatively high but was similar in the 2 trial groups. These rates were high but not dissimilar from those in real-life clinical practice47,48 and in randomized clinical trials of other symptomatic conditions.49-51 Nonretention rates were similar in the 2 groups, and sensitivity analyses of events censored 30 and 365 days after treatment discontinuation yielded similar results.





Conclusions

In middle-aged and older men with hypogonadism and prediabetes in the TRAVERSE Diabetes Study, the incidence of progression from prediabetes to diabetes did not differ significantly between testosterone- and placebo-treated men. Testosterone replacement therapy did not improve glycemic control in men with hypogonadism and prediabetes or diabetes.
 

madman

Super Moderator
Figure 1. CONSORT Diagram Showing the Flow of Study Participants Through Different Phases of the Study
1707670284186.png
 

madman

Super Moderator
Table. Baseline Characteristics of Study Participants in the Full Analysis Set and of Randomized Participants With Diabetes or Prediabetes
Screenshot (32929).png

Screenshot (32930).png
 

madman

Super Moderator
Figure 4. Estimated Changes From Baseline in Fasting Glucose and Hemoglobin A1c (HbA1c) Levels for Participants Who Had Prediabetes or Diabetes at Baseline
Screenshot (32933).png

Screenshot (32934).png
 

t_spacemonkey

Well-Known Member
your thoughts on HBa1c? ( I will do the insulin test next check up 6 months.)
i've run also a bit higher a1c since my teens. 5.3-5.5 or so. adding fruit to my carnivore diet pushes it tiny lower, ,keto higher. but all other markers are good. i think this is one of the few tests which should be followed according to typical lab ranges. unlikely that you will have low insulin and a diabetic a1c.
 

madman

Super Moderator


Testosterone replacement therapy in the treatment of hypogonadism showed no benefit in slowing the progression of prediabetes or diabetes, contrary to previous evidence that suggested potential improvements in insulin sensitivity and metabolism.

"The findings of this study suggest that testosterone replacement therapy alone should not be used as a therapeutic intervention to prevent or treat diabetes in men with hypogonadism," reported the authors of research published this month in JAMA Internal Medicine.

The suggestion that testosterone replacement could prevent or slow diabetes stems from numerous studies linking testosterone deficiency to a host of adverse effects that include increases in insulin resistance and an increased risk for prediabetes and type 2 diabetes.


Furthermore, one recent uncontrolled study showed a lower rate of progression from prediabetes to diabetes in testosterone-treated vs untreated men with hypogonadism.

But with no known randomized clinical trials evaluating the effects of testosterone on diabetes in the absence of a concurrent lifestyle intervention, Shalender Bhasin, MB, of the Research Program in Men's Health: Aging and Metabolism, at Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, and colleagues conducted a substudy of the randomized TRAVERSE trial, which was conducted at 316 sites in the United States.

"We hypothesized that testosterone replacement therapy for men with hypogonadism and prediabetes would be associated with a significantly lower rate of progression to diabetes,"
they wrote.

In the study, named the TRAVERSE Diabetes Study, 5204 participants aged between 40 and 85 years with hypogonadism as well as prediabetes (n = 1175) or diabetes (n = 3880) were randomized 1:1 to receive treatment either with 1.62% testosterone gel or placebo gel.

The participants had a mean age of 63.2 years, and the mean A1c among those with prediabetes was 5.8%.

For the primary outcome, the risk for progression to diabetes did not differ significantly between the testosterone-treated and placebo groups at 6 months (0.7% vs 1.4%), 12 months (7.8% vs 10.7%), 24 months (10.1% vs 14.6%), 36 months (12.8% vs 15.8%), or 48 months (13.4% vs 15.7%; omnibus test P = .49).

There were also no significant differences in terms of glycemic remission and the changes in glucose and A1c levels between the testosterone- and placebo-treated men with prediabetes or diabetes, consistent with findings from previous smaller trials.


The authors pointed out that the participants in the TRAVERSE trial had mild to moderate testosterone deficiency, and "it is possible that greater improvements in insulin sensitivity may be observed in men with severe testosterone deficiency."

However, they noted that most men with hypogonadism who are treated with testosterone replacement therapy have only mild testosterone deficiency.


The parent TRAVERSE study did show testosterone replacement therapy to be associated with higher incidences of venous thromboembolism, atrial fibrillation, and acute kidney injury; however, no additional between-group differences were observed based on diabetes or prediabetes status.

"The findings of this study do not support the use of testosterone replacement therapy alone to prevent or to treat diabetes in men with hypogonadism,"
the authors concluded.



Study 'Overcomes Limitations of Prior Studies'

In an editorial published concurrently with the study, Lona Mody, MD, of the Division of Geriatric and Palliative Care Medicine, University of Michigan Medical School, in Ann Arbor, Michigan, and colleagues underscored that "the results of this study suggest that testosterone replacement therapy will not benefit glycemic control in men without hypogonadism despite the inappropriately high rates of use in this group."

Further commenting to Medscape Medical News, Mody elaborated on the high rates of use, noting that data have shown androgen use among men over 40 years increased more than threefold from 0.81% in 2001 to 2.91% in 2011.

"Based on sales data, testosterone prescribing has increased 100-fold from $18 million in the late 1980s to $1.8 billion over three decades,"
Mody said.

She noted that while some previous research has shown a similar lack of benefits, "the current study overcomes some limitations of prior studies."

Ultimately, the evidence indicated that "the only major indication for testosterone replacement therapy remains to treat bothersome symptoms of hypogonadism," Mody said. "It does not appear to have metabolic benefits."

This trial was funded by a consortium of testosterone manufacturers led by AbbVie, Inc., with additional financial support provided by Endo Pharmaceuticals, Acerus Pharmaceuticals Corporation, and Upsher-Smith Laboratories, LLC.
 
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