Another New Female Viagra-Like Drug Study?

A must read for any man who has a girlfriend or wife who is not as interested in sex as she used to be.  This long but super interesting article talks about female arousal and the trials of using two combination drugs. 

"Both drugs have a peppermint-flavored testosterone coating that melts in the mouth. When the exterior is gone, the woman swallows a delayed-release inner tablet. In Lybrido, this inner pill is a close cousin of Viagra. The idea is that the Viagra-like molecule, by making extra blood flow to the genitals and adding to swelling and sensation, will work in conjunction with the testosterone. Together they will stir the mind to be more aware of erotic impulses; together they will help spark dopamine networks. Lybridos uses a compound called buspirone instead of the Viagra-like substance. Buspirone was originally used as an anti-anxiety medication, and if taken every day it can elevate serotonin in the brain. But as long as it’s taken no more than every other day, it has a unique short-term effect: for a few hours, serotonin is suppressed."

More details : The Female Viagra?

Testosterone Therapy in Women

Videos on hormones

Dairy food intake in relation to semen quality and reproductive hormone levels among physically active young men

Afeiche M, Williams PL, Mendiola J, et al. Dairy food intake in relation to semen quality and reproductive hormone levels among physically active young men. Human Reproduction.  http://humrep.oxfordjournals.org/content/early/2013/05/12/humrep.det133.abstract 

STUDY QUESTION Is increased consumption of dairy foods associated with lower semen quality?

SUMMARY ANSWER We found that intake of full-fat dairy was inversely related to sperm motility and morphology. These associations were driven primarily by intake of cheese and were independent of overall dietary patterns.

WHAT IS KNOWN ALREADY It has been suggested that environmental estrogens could be responsible for the putative secular decline in sperm counts. Dairy foods contain large amounts of estrogens. While some studies have suggested dairy as a possible contributing factor for decreased semen quality, this finding has not been consistent across studies.

STUDY DESIGN, SIZE, DURATION The Rochester Young Men's Study (n= 189) was a cross-sectional study conducted between 2009 and 2010 at the University of Rochester.

PARTICIPANTS/MATERIALS, SETTING, METHODS Men aged 18–22 years were included in this analysis. Diet was assessed via food frequency questionnaire. Linear regression was used to analyze the relation between dairy intake and conventional semen quality parameters (total sperm count, sperm concentration, progressive motility, morphology and ejaculate volume) adjusting for age, abstinence time, race, smoking status, body mass index, recruitment period, moderate-to-intense exercise, TV watching and total calorie intake.

MAIN RESULTS AND THE ROLE OF CHANCE Total dairy food intake was inversely related to sperm morphology (P-trend = 0.004). This association was mostly driven by intake of full-fat dairy foods. The adjusted difference (95% confidence interval) in normal sperm morphology percent was −3.2% (−4.5 to −1.8) between men in the upper half and those in the lower half of full-fat dairy intake (P < 0.0001), while the equivalent contrast for low-fat dairy intake was less pronounced [−1.3% (−2.7 to −0.07; P= 0.06)]. Full-fat dairy intake was also associated with significantly lower percent progressively motile sperm (P= 0.05).

LIMITATIONS, REASONS FOR CAUTION As it was a cross-sectional study, causal inference is limited.

WIDER IMPLICATIONS OF THE FINDINGS Further research is needed to prove a causal link between a high consumption of full-fat dairy foods and detrimental effects on semen quality. If verified our findings would mean that intake of full-fat dairy foods should be considered in attempts to explain secular trends in semen quality and that men trying to have children should restrict their intake.

STUDY FUNDING/COMPETING INTEREST(S) European Union Seventh Framework Program (Environment), ‘Developmental Effects of Environment on Reproductive Health’ (DEER) grant 212844. Grant P30 DK046200 and Ruth L. Kirschstein National Research Service Award T32 DK007703-16 from the National Institutes of Health. None of the authors has any conflicts of interest to declare.

Testosterone Replacement Helps Heal Inside of Blood Vessels

Summary

Circulating endothelial progenitor cells (EPCs) are bone marrow-derived cells required for endothelial repair. A low EPC number can be considered as an independent predictor of endothelial dysfunction and future cardiovascular events. Recent evidence shows that patients with hypogonadal symptoms without other confounding risk factors have a low number of circulating progenitor cells (PCs) and EPCs, thus highlighting the role of testosterone in the proliferation and differentiation of EPCs. Here, we investigate if testosterone replacement therapy (TRT) can increase circulating EPC number in men with late onset hypogonadism. Forty-six men (age range, 40–73 years; mean age, 58.3 years) with hypogonadal symptoms were recruited, and 29 men with serum total testosterone (TT) levels less than 350 ng/dL received TRT using transdermal testosterone gel (Androgel; 1% testosterone at 5 g/day) for 12 months. Circulating EPC numbers (per 100 000 monocytes) were calculated using flow cytometry. There was no significant association between serum TT levels and the number of circulating EPCs before TRT. Compared with the number of mean circulating EPCs at baseline (9.5 ± 6.2), the number was significantly higher after 3 months (16.6 ± 11.1, p = 0.027), 6 months (20.3 ± 15.3, p = 0.006) and 12 months (27.2 ± 15.5, p = 0.017) of TRT. Thus, we conclude that serum TT levels before TRT are not significantly associated with the number of circulating EPCs in men with late onset hypogonadism. However, TRT can increase the number of circulating EPCs, which implies the benefit of TRT on endothelial function in hypogonadal men.

Testosterone increases the number of blood vessel repairing cells

The Prevalence Of Prior Use Of Anabolic Androgenic Steroids In Young Hypogonadal Men

The Prevalence Of Prior Use Of Anabolic Androgenic Steroids In Young Hypogonadal Men

http://www.aua2013.org/abstracts/archive/printabstracts.cfm?id=1395 

Introduction and Objectives - Testosterone replacement therapy (TRT) for hypogonadism has increased significantly in the past decade. In 2011, 1.3% of all 19-30 year olds reported prior use of anabolic androgenic steroids (AAS) (Johnson, 2012). This trend has led to a heightened sense of awareness surrounding AAS use and the potential for transient or permanent hypogonadotropic hypogonadism. The prevalence and attitudes of men with a history of prior AAS use presenting with symptomatic hypogonadism requiring TRT has never been reported.

Methods - An anonymous, prospective, IRB-approved survey was distributed to men with symptomatic hypogonadism over a 6-month period in 2012. Basic demographic information and choice of TRT was documented as was the nature and attitudes regarding prior AAS use. Statistical analysis was performed with student’s t-test and Fisher’s exact test 

Results - A total of 138 men (mean age 45.7 ±11.7) currently receiving TRT for hypogonadism participated, and 31% (n=43; mean age 39.4 ±7.4) reported a history of prior AAS use. Among hypogonadal men ≤ 50 years old, 43.6% (n=41) used AAS in the past compared to 4.5% (n=2) in those < 50 years old.  Men with previous AAS use were 9.1 years younger on presentation than men without an AAS history

In men with an AAS history, moving forward, treatment for hypogonadism via testosterone injections was preferred by 93%, while 46% without a history of AAS use preferred injections

Conclusions - Prior AAS use is relatively common in men seeking treatment for symptomatic hypogonadism. Although this only represents one center, the prevalence was approximately ten times higher in hypogonadal men under age 50 years than those over. This information was not known prior to treatment and highlights the need to be cautious about prescribing TRT to younger patients. Perhaps prescription of alternative medications with lower likelihood for abuse (e.g. selective estrogen receptor modulators or aromatase inhibitors) would be more prudent in younger patients with symptomatic hypogonadism.

Evaluation Of Enclomiphene And Testosterone Gel

http://www.aua2013.org/abstracts/archive/printabstracts.cfm?id=98768  Introduction and Objectives - Enclomiphene, the trans diastereoisomer of clomifene, is a selective oestrogen receptor modulator (SERM) in the pituitary. Blocking the negative oestrogenic feedback results in increased luteinising hormone (LH) levels which then stimulate production of endogenous T. Exogenous T has been shown to reduce spermatogenesis which could be counterproductive in men wishing to preserve fertility. This study compares the impact of enclomiphene with one T gel on certain aspects of endocrine function and spermatogenesis. Methods - A double-blind, placebo and active control study of two doses of enclomiphene (12.5 and 25 mg) with open-label on-demand T gel in 120 patients with secondary hypogonadism over a 3-month period. Men were 21-65 years and had not received exogenous T within the previous 6 months. Results - All three active groups exhibited statistically significant increases (ng/dl) from baseline in T compared to placebo (Enclomiphene 12.5 mg 217-472; 25 mg 210 406: T gel 210-463: Placebo 214-199). Enclomiphene at both doses increased LH and follicle stimulating hormone (FSH) levels (mIU/ml) beyond baseline and placebo whereas T gel resulted in a >50% reduction in both pituitary hormones (LH Enclomiphene 12.5 mg 4.4-8.9; 25 mg 5.3-11.7: T gel 3.9-1.4: Placebo 3.9-3.7: FSH Enclomiphene 12.5 mg 6.4-11.5; 25 mg 9.4-14.1: T gel 6.0-2.9: Placebo 6.1-5.4). At baseline, the majority of men in all groups exhibited sperm concentrations above the World Health Organization (WHO) limit of normal (15 million sperm per ml of semen). This was maintained in the enclomiphene groups and the placebo group. However, in 13 out of 23 men in the T gel group the sperm concentration dropped below normal. Conclusions - Enclomiphene acts at the level of the pituitary as a selective oestrogen receptor modulator to block the negative feedback of oestrogen on the pituitary hormones (LH and FSH). The present study shows that restoration of LH (secondary hypogonadal males having low levels) provides rapid and effective normalisation of T levels with no excursion into the supra-normal range. In addition, preservation of FSH levels in enclomiphene-treated patients ensures that there is no negative impact on sperm function. In contrast, the suppression of sperm function in the T gel group is likely to be a consequence of the observed reduction in FSH. Overall, this study shows that enclomiphene may provide effective therapy in men with secondary hypogonadism, particularly in those wishing to preserve fertility

Testosterone Supplementation Does Not Worsen Lower Urinary Tract Symptoms

Testosterone Supplementation Does Not Worsen Lower Urinary Tract Symptoms  [Abstract: 1384] 

http://www.aua2013.org/abstracts/archive/printabstracts.cfm?id=1384 

Introduction and Objectives - Testosterone replacement therapy (TRT) is commonly used to treat men with hypogonadism; however, there has been caution is using TRT in men with moderate to severe lower urinary tract symptoms (LUTS) for fear of worsening their symptoms. The primary objective of this study was to examine the effect of TRT on LUTS in hypogonadal men.

Methods - We retrospectively reviewed Northwestern Memorial Faculty Foundation’s (NMFF) outpatient database and identified patients with a diagnosis of hypogonadism who received TRT from 2002 to 2012. LUTS were assessed by use of the AUASI pre- and post- TRT. Testosterone and PSA were also continuously measured, and all patients were closely monitored for side effects to TRT. Patients who had progression of their LUTS to the point of requiring surgery were included in the study until the point of their operation.

Results - We identified 120 hypogonadal men who underwent TRT, the majority of whom had topical therapy or a combination of topical and pellet based therapy (57.5% and 20.8%, respectively). The mean baseline AUASI was 10.8 and our mean duration of TRT was 23 months.

The mean change in AUASI was -1.07, with a range from -19 to 15. The mean baseline PSA was 1.6 and the mean change in PSA was 0.44, with a range from -10.4 to 11.4. 6.7% of patients had a baseline PSA >4.0, and they had greater improvement in AUASI than those patients with baseline PSA <4 --1.-31.7=""> 3 points while 22.5% had worsening of their AUASI >3 points. Patients with an improved AUASI had a mean PSA change of 0.3, while those who had worsening of their AUASI had a mean PSA change of 0.7 (pNS).

Approximately 7.5% of these men initiated new medications for their LUTS during the course of the study and there was no significant change in their AUASI when compared to patients without any change in their medications. Additionally, 3.3% of patients had progression of their LUTS and required transurethral resection of the prostate.

Conclusions - We demonstrate that initiating TRT in hypogonadal men does not cause a worsening of their LUTS, in fact many men have an improvement in symptoms while PSA changes appear minor. Future research should focus on larger patient population studies to further examine this relationship.

Variable Accuracy of Testosterone Concentrations in Compounded Testosterone Products

Accuracy of Testosterone Concentrations in Compounded Testosterone Products

Ethan Grober; Andrea Bozovic; Fanipour Majid; Vathany Kulasingam; Eleftherios Diamandis

Abstract: 1510

http://www.aua2013.org/program/plenary.cfm

Introduction and Objectives
Many patients with testosterone deficiency inquire about the use of compounded testosterone products as an option for testosterone replacement. The safety and accuracy of the active ingredients within these products is not well established. The current study evaluated the accuracy of the testosterone concentrations within testosterone gels and creams manufactured by compounding pharmacies.

Methods
Ten compounding pharmacies within Toronto with experience in compounding testosterone products were included in this study. All pharmacies were blinded as to the nature of the study. A standardized prescription for 50mg of compounded testosterone gel/cream applied once daily was presented to each pharmacy. Two independently compounded samples (batch 1 and 2) were analyzed from each of the 10 pharmacies 1 month apart. For quality control, several samples from each batch were tested. Testosterone concentrations in a 5g sachet of Androgel 1% (Abbott) and 5g tube of Testim 1% (Auxilium) were evaluated as controls. Samples were analyzed independently and in a blinded fashion by the Department of Laboratory Medicine at the University of Toronto. Measurement of testosterone concentration was performed using a modified liquid chromatography tandem mass spectrometry validated for serum testosterone. Results are reported as % testosterone recoved compared to the prescribed testosterone concentration.

Results
Compounded formulations included 7 gels and 3 creams with a volume/daily dose ranging from 0.2ml -1.25ml. Product cost ranged from $26 to $75 for a 7-day supply. There was significant variability both within and between pharmacies with respect to the measured concentration of testosterone in the compounded products (Figure 1). In contrast, the concentration of testosterone within Androgel and Testim was consistent and accurate. Collectively, only 50% (batch 1) and 30% (batch 2) of the compounding pharmacies provided a product with a testosterone concentration within +/-20% of the prescribed dose. Two pharmacies compounded products with >20% of the prescribed dose. One pharmacy compounded a product with essentially no testosterone.

Conclusions
Testosterone concentrations in compounded testosterone products can be variable and potentially compromise the efficacy and safety of treatment.