Andrew McCullough

Albany Medical College, Albany, New York, United States

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Publications (76)225.83 Total impact

  • Edward D Kim · Andrew McCullough · Jed Kaminetsky ·
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    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(®) 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.
    BJU International 10/2015; DOI:10.1111/bju.13337 · 3.53 Impact Factor
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    ABSTRACT: Hypogonadism (HG, testicular failure in men) has become a controversial and much misunderstood condition. Many men perceive testosterone as a panacea for the ills of ageing and "Low-T clinics" have sprung up to meet their demands, even though testosterone is often not the answer. In light of the unprecedented rise in testosterone prescriptions in recent years, particularly amongst middle-aged men, the US Food and Drug Administration (FDA) issued a Safety Communication in May 2015 intended to restrict the use of testosterone. This article is protected by copyright. All rights reserved.
    BJU International 09/2015; DOI:10.1111/bju.13316 · 3.53 Impact Factor
  • J. Ellen · C. Welliver · A. McCullough ·

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    ABSTRACT: Aim: Clomiphene citrate (CC) and anastrozole (AZ) have been used off label to increase testosterone (T) in hypogonadal infertile men (HIM). Both medications have been shown to increase T with different effects on estradiol (E2) and T-to-E2 ratios. There are no reported randomized trials comparing CC and AZ to improve T levels in HIM. We aimed to establish equivalence of CC vs. AZ with respect to improvement in T levels in HIM. Methods: We randomized 26 HIM (T less than 350ng/dL and normal luteinizing hormone [LH]). Patients were randomized to CC (25mg/day) or AZ (1mg/day) for 12 weeks. Hormones assayed were total T, free T, E2, LH, follicle stimulating hormone (FSH), and sex hormone binding globulin (SHBG). Patient-reported outcomes were the International Index of Erectile Function, Erection Hardness Scale, and the Androgen Deficiency in the Aging Male questionnaires. Blood tests and questionnaires were recorded at baseline, 6 and 12 weeks. Semen analyses were performed at baseline and 12 weeks. Results: T increased significantly from baseline in both groups at 6 and 12 weeks. There was a significantly larger increase in T and mean increase from baseline in CC vs. AZ (571 vs. 408ng/dL, respectively). Whereas E-2 levels increased in the CC group, they decreased in the AZ group. Though both groups demonstrated an increase in T-to-E-2 ratio from baseline, statistic significance at 6 and 12 weeks was only achieved with AZ. Neither group demonstrated significant changes in seminal parameters or patient-reported outcomes. Conclusions: We failed to demonstrate equivalence of CC vs. AZ. CC resulted in significantly higher T levels than AZ. AZ resulted in a significantly larger increase in T/E-2 ratio than CC. No significant differences between CC and AZ on seminal parameters or patient-reported outcomes were demonstrated.
    Journal of Sexual Medicine 07/2015; 12(8). DOI:10.1111/jsm.12944 · 3.15 Impact Factor
  • Igor Sorokin · Charles Welliver · Leon Elebyjian · Paul J. Feustel · Andrew McCullough ·
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    ABSTRACT: To determine the variability of testicular ultrasound (US) volumes and the clinical implications. A retrospective review identified 73 patients (62 adult and 11 adolescents) who had testicular US scans performed at both our institution (Urological Institute at Northeastern New York) and at an outside facility (outside hospital study). Testicular volume (TV) was measured using the Lambert formula: length × width × height × 0.71. TV difference (TVD) was calculated as percentage difference = 100 × (right TV - left TV)/left TV and serves as the intrapatient TVD. Patients with clinically palpable varicoceles were correlated to detection on US. Bland-Altman plots were generated to compare the limits of agreement for interinstitutional TVs. Interinstitutional agreement was measured using the Kappa (κ) coefficient. Although the mean values for TVs were similar between institutions (19.1 vs 19.0 cm(3)), there was a wide range in the limits of agreement with a large standard deviation of difference (8.52 cm(3)). Interinstitutional agreement was poor regarding patients with a ≥20% TVD (κ = 0.09) and was even worse in patients with both varicoceles and ≥20% TVD (κ = 0.05). US agreement for verification of clinically detected varicoceles was good (κ = 0.67). If the variability found in this study was applied to identically sized testicles, an erroneous 20% TVD would be found in 38% of studies. Interinstitutional or inter-ultrasonographer assessment of TV varies significantly. Clinicians should cautiously interpret the US-determined TV when making surgical decisions. Images, and not just reports, should be reviewed by clinicians. Copyright © 2015 Elsevier Inc. All rights reserved.
    Urology 05/2015; 85(5). DOI:10.1016/j.urology.2015.02.018 · 2.19 Impact Factor
  • Joseph Ellen · Igor Sorokin · Clay Mechlin · Charles Welliver · Andrew McCullough ·

    The Journal of Urology 04/2015; 193(4):e773. DOI:10.1016/j.juro.2015.02.2271 · 4.47 Impact Factor
  • Andrew McCullough ·
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    ABSTRACT: The European Male Aging Study has demonstrated that the hypogonadism of male aging is predominantly secondary. Theoretically with appropriate stimulation from the pituitary, the aging testis should be able to produce eugonadal levels of testosterone. The strategies for the treatment of late onset hypogonadism (LOH) have focused on replacement with exogenous testosterone versus restoration of endogenous production. The purpose of this article is to review existing peer-reviewed literature supporting the concept of restoration of endogenous testosterone in the treatment of LOH.
    Asian Journal of Andrology 12/2014; 17(2). DOI:10.4103/1008-682X.143736 · 2.60 Impact Factor
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    Andrew McCullough ·
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    ABSTRACT: Currently, the most popular form of testosterone replacement is the topical gels that require daily applications and incur a risk of transfer of testosterone to partners and family. One of the problems with testosterone replacement is the short half-life of testosterone. A long-acting formulation is appealing to patients and physicians. In 1972, fused crystalline testosterone pellets were approved in the USA by the FDA but they were not marketed until 2008. Pharmacokinetics studies were available on a different formulation from which much can be learned and applied to the current formulation, Testopel®. The decay kinetics, pituitary suppression, and effect on other sex steroids are reviewed as well as the short-term complication rates. This review should provide the testosterone pellet implanter a better understanding of the physiology of testosterone pellet supplementation for hypogonadism.
    Current Sexual Health Reports 12/2014; 6(4). DOI:10.1007/s11930-014-0033-7
  • R Charles Welliver · Clay Mechlin · Brianne Goodwin · Joseph P Alukal · Andrew R McCullough ·
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    ABSTRACT: Provoked and spontaneous nocturnal erections are thought to play a role in maintenance of male sexual health through oxygenation of the corpus cavernosa. Conversely, hypoxia is thought to be an etiological factor in the pathogenesis of cavernosal fibrosis and long-term erectile dysfunction. It has been hypothesized that the early penile hypoxia after radical prostatectomy (RP) may lead to fibrosis and consequently a decrease in stretched penile length and long-term erectile dysfunction. The aim of this study was to assess the changes in penile tissue oxygenation with vacuum erection device (VED) use. Twenty men between 2 and 24 months following RP were enrolled prospectively. Each man cycled a VED to achieve full erection 10 consecutive times over a period of approximately 2 minutes without constriction ring. Tissue oximetry was measured at baseline and immediately after VED using a tissue oximeter at five sites: right thigh, right corpora, glans, left corpora, and left thigh. Additional measurements were captured over the course of an hour. Mean age and time from surgery was 58.2 years and 12.6 months, respectively, and the average Sexual Health Inventory for Men score was 7. Use of the VED significantly increased both glanular and corporal oximetry relative to the baseline values for the entire 60 minutes. An initial increase of 55% was seen in corporal oxygenation with VED use. This is the first study demonstrating that a single, brief application of the VED without a constriction ring results in significant improvement in penile oxygen saturation. The use of a VED has significant benefits for patients both with regard to cost and invasiveness when compared with other penile rehabilitation protocols. Welliver RC Jr, Mechlin C, Goodwin B, Alukal JP, and McCullough AR. A pilot study to determine penile oxygen saturation before and after vacuum therapy in patients with erectile dysfunction after radical prostatectomy. J Sex Med **;**:**-**.
    Journal of Sexual Medicine 02/2014; 11(4). DOI:10.1111/jsm.12445 · 3.15 Impact Factor
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    Clay W Mechlin · Jason Frankel · Andrew McCullough ·
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    ABSTRACT: Introduction Current U.S. Food and Drug Administration-approved therapies for hypogonadism involve testosterone (T) replacement. Testosterone pellets (TP) require a minor office procedure every 3 to 4 months. The need for repeated insertions increases the likelihood of a complication. Anastrozole (AZ) is an aromatase inhibitor that has been used off-label for the treatment of male hypogonadism. AZ increases T levels by lowering serum estradiol (E2) levels and increasing gonadotropin (GTP) levels. Aim We hypothesized that the concomitant use of AZ with TP insertions would sustain therapeutic T levels and increase the interval between TP insertions. Methods Men treated with TP for hypogonadism at an academic center were offered AZ (1 mg/day) at the time of TP reinsertion as a way of potentially decreasing the frequency of TP insertions. Total T (TT), free T (FT), sex hormone binding globulin, E2, luteinizing hormone (LH), and follicle-stimulating hormone FSH levels were obtained prior to T replacement and at 6 and 15 weeks from TP insertion. Men were re-implanted at 16 weeks if their TT levels were less than 350 ng/dL and their symptoms recurred. We retrospectively reviewed our records of men who underwent TP, TP, and AZ from 2011 to 2012. Demographics, TT, FT, LH, FSH, and E2 levels were recorded. Data were analyzed with anova and a Tukey's test. Main Outcome Measure TT level at 6, 15, or >15 weeks from TP insertion. Results Thirty-eight men with 65 insertions were analyzed. The TP AZ group had significantly higher TT and FT levels than the TP group at >120 days (P<0.05). The TP group had significantly higher E2 levels at all time points (P<0.01). GTP levels remained stable in the TP AZ group. Average time to reinsertion in TP AZ was 198 days vs. 128 days in the TP group. Conclusion Men on TP AZ maintain therapeutic T levels longer than men on TP alone and have significantly less GTP suppression.
    Journal of Sexual Medicine 10/2013; 11(1). DOI:10.1111/jsm.12320 · 3.15 Impact Factor
  • A.E. Ahmad · M. Lao · C.W. Mechlin · M. Forman · P.M. Horvath · A.R. McCullough ·

    Fertility and Sterility 09/2013; 100(3):S211. DOI:10.1016/j.fertnstert.2013.07.1327 · 4.59 Impact Factor
  • Clay Mechlin · Andrew McCullough ·

    The Journal of Urology 04/2013; 189(4):e653-e654. DOI:10.1016/j.juro.2013.02.3141 · 4.47 Impact Factor
  • Clay Mechlin · Andrew McCullough ·

    The Journal of Urology 04/2013; 189(4):e652-e653. DOI:10.1016/j.juro.2013.02.3140 · 4.47 Impact Factor
  • L H Belkoff · A McCullough · I Goldstein · L Jones · C H Bowden · K Didonato · B Trask · W W Day ·
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    ABSTRACT: Aim: Determine the long-term efficacy, safety and tolerability of avanafil, a highly specific, rapidly absorbed phosphodiesterase type 5 inhibitor in male patients with mild to severe erectile dysfunction (ED), with or without diabetes. Methods: This was a 52-week, open-label extension of two 12-week, randomised, placebo-controlled, phase 3 trials. Patients were assigned to avanafil 100 mg, but could request 200 mg (for increased efficacy; ‘100/200-mg’ group) or 50 mg (for improved tolerability). Primary end points included percentage of sexual attempts ending in successful vaginal penetration [Sexual Encounter Profile 2 (SEP2)] and intercourse (SEP3) and erectile function domain score per the International Index of Erectile Function (IIEF-EF). Results: Some 712 patients enrolled; 686 were included in the intent to treat population and contributed to the data. All primary end points showed sustained improvement. SEP2 and SEP3 success rates improved from 44% to 83% and from 13% to 68% (100-mg group) and from 43% to 79% and from 11% to 66% (100/200-mg group), respectively. Mean IIEF-EF domain scores improved from 13.6 to 22.2 (100-mg group) and from 11.9 to 22.7 (100/200-mg group). Avanafil was effective in some patients ≤ 15 min and > 6 h postdose. Sixty-five per cent (112/172) of ‘nonresponders’ to avanafil 100 mg responded to the 200-mg dose. The most common (≥ 2%) treatment-emergent adverse events were headache, flushing, nasopharyngitis and nasal congestion; < 3% of patients discontinued therapy because of adverse events. Conclusions: The long-term tolerability and improvement in sexual function, coupled with rapid onset, suggest that avanafil is well suited for the on-demand treatment of ED.
    International Journal of Clinical Practice 04/2013; 67(4):333-41. DOI:10.1111/ijcp.12065 · 2.57 Impact Factor
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    ABSTRACT: Implantable testosterone pellets were approved by the Food and Drug Administration in 1972 for the treatment of testosterone deficiency syndrome (TDS). Clinical use of this testosterone delivery modality has been limited until its recent reintroduction (Testopel(®) , Slate Pharmaceuticals, Durham, NC, USA). Six academic institutions collaborated and combined their databases to more fully characterize serum testosterone levels after the pellet implantations. To assess the time-dependent serum testosterone levels after subcutaneous testosterone pellets in clinical practice for the treatment of TDS. Data were retrospectively pooled and analyzed from data in six academic institutions. Variables included patient age, total testosterone concentrations before and after implantation, the number of testosterone pellets implanted, and the time from implantation to measurement of serum testosterone concentrations. Three hundred eighty men undergoing 702 insertions were included for analysis using JMP (version 4.0.4; SAS Institute, Cary, NC, USA). Main outcome measures were postimplantation total testosterone levels and investigator-reported adverse events. Testosterone levels as a function of the number of pellets implanted and time from implantation were assessed. Implantation of six to ≥10 testosterone pellets (450 to ≥750 mg) increased total testosterone into the therapeutic range at 1 month postimplantation and sustained therapeutic levels (>300) for 4-6 months. Higher pellet numbers (10-12 pellets) were associated with higher, more consistent, and longer maintenance of testosterone levels within the therapeutic range. Four extrusions and three hematomas were reported early in our experience; other investigator-reported adverse events were generally mild to moderate in nature and transient in duration. No subjects required analgesics. Testosterone pellets (Testopel(®) , Slate Pharmaceuticals) provide sustained levels of testosterone for at least 4 months and up to 6 months in men with TDS. Implantation of ≥8 pellets achieved optimal results with respect to peak mean testosterone level and duration of effect. Testosterone pellets were generally well tolerated.
    Journal of Sexual Medicine 02/2012; 9(2):594-601. DOI:10.1111/j.1743-6109.2011.02570.x · 3.15 Impact Factor
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    ABSTRACT: Phosphodiesterase type 5 (PDE5) inhibitors have become standard treatment for erectile dysfunction (ED). To prospectively evaluate the safety and efficacy of avanafil, a novel PDE5 inhibitor, in men with mild to severe ED. In this multicenter, double-blind, Phase 3 trial, 646 subjects were randomized to receive avanafil (50 mg, 100 mg, 200 mg) or placebo throughout a 12-week treatment period. Subjects were instructed to take study drug 30 minutes prior to initiation of sexual activity. At least a 12-hour separation time between doses was required; no restrictions were placed on food or alcohol intake. Improvement in erectile function (EF) was measured by Sexual Encounter Profile questions 2 and 3 (SEP2 and SEP3) and by the EF domain of the International Index of Erectile Function (IIEF) questionnaire. Mean change in percentage of successful sexual attempts (SEP2 and SEP3) and IIEF-EF domain score significantly favored all doses of avanafil over placebo (P ≤ 0.001). Secondary analyses demonstrated achievement of successful intercourse by subjects within 15 minutes of dosing. Of the 300 sexual attempts made during this interval, 64% to 71% were successful in avanafil-treated subjects compared with 27% in placebo-treated subjects. Successful intercourse was also demonstrated >6 hours post dosing, with 59% to 83% of the 80 sexual attempts successful in avanafil-treated subjects compared with 25% of placebo-treated subjects. The most commonly reported adverse events in subjects taking avanafil included headache, flushing, and nasal congestion; there were no drug-related serious adverse events. Following 12 weeks of avanafil treatment without food or alcohol restrictions, significant improvements in sexual function were observed with all 3 doses of avanafil compared with placebo. Successful intercourse was observed as early as 15 minutes and >6 hours after dosing in some subjects. Avanafil was generally well tolerated for the treatment of ED.
    Journal of Sexual Medicine 01/2012; 9(4):1122-33. DOI:10.1111/j.1743-6109.2011.02629.x · 3.15 Impact Factor
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    Sidney Glina · William J Sommers · Andrew R McCullough ·

    Journal of Sexual Medicine 02/2011; 8(2):337-40. DOI:10.1111/j.1743-6109.2010.02186.x · 3.15 Impact Factor

  • Journal of Men s Health 10/2010; 183(4). DOI:10.1016/j.juro.2010.02.1234 · 0.49 Impact Factor
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    ABSTRACT: To our knowledge we report the first large, randomized, prospective penile rehabilitation clinical trial to compare the effectiveness of nightly intraurethral alprostadil vs sildenafil citrate after nerve sparing prostatectomy. We performed a prospective, randomized, open label, multicenter American study in men with normal erectile function who underwent bilateral nerve sparing radical prostatectomy. The International Index of Erectile Function erectile function domain was the primary end point. Subjects initiated nightly treatment within 1 month of surgery with intraurethral alprostadil or oral sildenafil citrate (50 mg) for 9 months. After 1-month washout and before sexual activity subjects self-administered sildenafil citrate (100 mg) for a total of 6 attempts in 1 month. Secondary end points were the global assessment question, sexual encounter profile, Erectile Dysfunction Inventory of Treatment Satisfaction and measured stretched penile length. Of 139 men who started intraurethral alprostadil and 73 who started sildenafil citrate, 97 and 59, respectively, completed the trial. There were no statistically significant differences in International Index of Erectile Function erectile function domain and intercourse success rates to intraurethral alprostadil. The global assessment question was significantly better only at 6 months for intraurethral alprostadil (p <0.028). At completion there were no differences between treatments for any of the end points. This is the first study to directly compare the ability of alprostadil and a phosphodiesterase-5 inhibitor to enhance penile recovery subsequent to bilateral nerve sparing radical prostatectomy. The use of nightly subtherapeutic intraurethral alprostadil is well tolerated after radical prostatectomy. The benefit to return of erectile function of nightly sildenafil citrate and subtherapeutic intraurethral alprostadil appears to be comparable within the first year of surgery.
    The Journal of urology 06/2010; 183(6):2451-6. DOI:10.1016/j.juro.2010.01.062 · 4.47 Impact Factor
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    John P Mulhall · Anthony J Bella · Alberto Briganti · Andrew McCullough · Gerald Brock ·
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    ABSTRACT: Prostate cancer is common and is being diagnosed in younger men now compared with two decades ago. Long-term functional outcomes are of significant importance to patient and impact upon the patient decision-making process regarding choice of therapy. Erectile function preservation (rehabilitation) has gained significant traction worldwide despite the absence of definitive evidence in its favor. To define the role of rehabilitation in the prostate cancer patient who has undergone radical prostatectomy (RP). A committee of five experts in the field from three countries was convened, and using a thorough analysis of the literature and the Delphi approach to expert opinion, recommendations were arrived at for clinicians treating men with prostate cancer before and after definitive surgical management. Recommendations arrived at included: that clinicians should discuss prevalence rates, the pathophysiology of erectile dysfunction after RP and the predictors of erectile function recovery, that validated instruments should be used using the published cut-offs for normalcy, that rehabilitation be discussed with patients, and that they be informed that significant potential benefits may be associated with rehabilitation. The International Consensus of Sexual Medicine (ICSM) 2001 committee on rehabilitation after radical prostatectomy recommended that a discussion occur regarding rehabilitation in all patients undergoing or who have undergone RP. However, the committee recognized the absence of definitive data to date and could not comment on the optimal approach to rehabilitation at this time.
    Journal of Sexual Medicine 04/2010; 7(4 Pt 2):1687-98. DOI:10.1111/j.1743-6109.2010.01804.x · 3.15 Impact Factor

Publication Stats

1k Citations
225.83 Total Impact Points


  • 2012-2015
    • Albany Medical College
      Albany, New York, United States
  • 2002-2011
    • NYU Langone Medical Center
      New York, New York, United States
    • Aristotle University of Thessaloniki
      Saloníki, Central Macedonia, Greece
  • 1997-2010
    • CUNY Graduate Center
      New York, New York, United States
  • 2008
    • University of California, Los Angeles
      Los Ángeles, California, United States
    • George Washington University
      Washington, Washington, D.C., United States
    • Gracie Square Hospital, New York, NY
      New York City, New York, United States