Testosterone studies this week: En Clomiphene , Axiron and more.

Nelson Vergel

Founder, ExcelMale.com
Oral Enclomiphene Citrate Raises Testosterone and Preserves Sperm Counts in Obese Hypogonadal Men
Posted: 27 Oct 2015 09:18 AM PDT
Kim ED, McCullough A, Kaminetsky J. Oral enclomiphene citrate raises testosterone and preserves sperm counts in obese hypogonadal men, unlike topical testosterone: restoration instead of replacement. BJU Int. http://onlinelibrary.wiley.com/doi/10.1111/bju.13337/abstract


OBJECTIVES: To determine the effects of daily oral doses of enclomiphene citrate compared with topical testosterone gel treatment on serum total testosterone (TT), luteinising hormone (LH), follicle-stimulating hormone (FSH), and sperm counts in men with secondary hypogonadism.


PATIENTS AND METHODS: Two parallel randomised, double-blind, double-dummy, placebo-controlled, multicentre, phase III studies were undertaken to evaluate two doses of enclomiphene citrate vs testosterone gel (AndroGel(R) 1.62%) on TT, LH, FSH, and sperm counts in overweight men aged 18-60 years with secondary hypogonadism.


Men were screened and enrolled in the trials (ZA-304 and ZA-305). All enrolled men had early morning serum TT levels in the low or low normal range (</=300 ng/dL; </=10.4 nmol/L) and had low or normal LH (<9.4 IU/L) levels measured on two separate occasions 2-10 days apart.


Serum samples were obtained over the course of the study to determine relevant hormone levels at baseline and after 16 weeks of treatment. Men provided semen samples twice to enroll at the beginning and twice at the end of the study.


RESULTS: TT levels increased between baseline and after 16 weeks of treatment in all the treatment groups. FSH and LH levels increased in the enclomiphene citrate groups and decreased in the testosterone gel group at 16 weeks.


Enclomiphene citrate maintained sperm concentration in the normal range over the treatment period, while there was a marked reduction in spermatogenesis in the testosterone gel group.


CONCLUSIONS: Enclomiphene citrate consistently increased serum TT, LH and FSH, restoring normal levels of serum TT. Enclomiphene citrate treatment maintained sperm concentrations in the normal range. The effects on TT were also seen with testosterone replacement via testosterone gel but sperm counts were not maintained.





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Effect of Testosterone Solution 2% on Testosterone Concentration, Sex Drive and Energy
Posted: 27 Oct 2015 09:16 AM PDT
Brock G, Heiselman D, Maggi M, et al. Effect of Testosterone Solution 2% on Testosterone Concentration, Sex Drive and Energy in Hypogonadal Men: Results of a Placebo-Controlled Study. J Urol. http://www.sciencedirect.com/science/article/pii/S0022534715050235


PURPOSE: To determine the effect of testosterone solution 2% on total testosterone level, and 2 symptoms of hypogonadism, sex drive and energy level.


MATERIALS AND METHODS: This was a randomized, multi-center, double-blind, placebo-controlled, 16-week study to compare the effect of testosterone and placebo on the proportion of men having a testosterone level within the normal range (300-1050 ng/dL) upon treatment completion, and to assess the impact of testosterone on sex drive and energy level, measured using the Sexual Arousal, Interest, and Drive scale (SAID) and the Hypogonadism Energy Diary (HED), respectively.


Males >/=18 years (N=715), with total testosterone <300 ng/dL and at least one symptom of testosterone deficiency (decreased energy, decreased sexual drive) were randomized to 60mg topical testosterone solution 2% or placebo once daily.


RESULTS: For study completers, 73% in the testosterone versus 15% in the placebo group had a testosterone level within the normal range at endpoint (p<0.001).


Participants assigned testosterone showed greater baseline-to-endpoint improvement in SAID scores (low sex drive subset; p<0.001 versus placebo) and HED scores (low energy subset; p=0.02 versus placebo [not significant at pre-specified p<0.01]).


No major adverse cardiovascular or venous thrombotic events were reported in the testosterone group; the incidence of increased hematocrit was higher with testosterone (p=0.04 versus placebo).


CONCLUSIONS: Once-daily testosterone solution 2% for 12 weeks was efficacious in restoring normal testosterone levels and improving sexual drive in hypogonadal men. Improvement was also seen in energy levels on the HED though not at the pre-specified p<0.01. No new safety signals were identified.



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Multiple Intussusceptions Associated with Polycythemia in an Anabolic Steroid Abuser, A Case Report and Literature Review
Posted: 27 Oct 2015 08:33 AM PDT
“He was [using] 1500 mg of testosterone/nandrolone, via intramuscular injection, per week for 3 months. 3 weeks prior to the presentation, he abruptly decreased the dose to 500 mg/week.”


Cavanagh Y, Shah N, Thomas AB, Gupta A. Multiple Intussusceptions Associated with Polycythemia in an Anabolic Steroid Abuser, A Case Report and Literature Review. Ann Med Health Sci Res 2015;5(5):368-72. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4594352/


Intussusceptions are generally associated with mechanical lead points or localized inflammation that function as foci for intestinal telescoping.


We present the case of a patient whose abuse of anabolic steroids resulted in the development of multiple simultaneous intussusceptions. Our patient had no additional identifiable risk factors for intussusception.


Consistent with previous reports, corticosteroid induced polycythemia and its consequent hyperviscosity led to intravascular sludging and mesenteric ischemia with associated bowel wall thickening. The localized intestinal induration then served as mechanical foci for intussusception.


Due to the illicit nature of anabolic androgenic steroid (AAS) abuse, the physiologic effects of supraphysiologic doses are sparsely reported and poorly understood. The scope of AAS abuse and its consequences are likely under-reported and under-recognized within the medical community.



Our case presented a unique diagnostic and therapeutic challenge with which we aim to increasing awareness and clinical suspicion for AAS among healthcare personnel.

 

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