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Guideline Summary
Guideline Title
Testosterone therapy in adult men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline.
Bibliographic Source(s)
Bhasin S, Cunningham GR, Hayes FJ, Matsumoto AM, Snyder PJ, Swerdloff RS, Montori VM, Task Force, Endocrine Society. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2010 Jun;95(6):2536-59. [151 references] PubMed External Web Site Policy
Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Bhasin S, Cunningham GR, Hayes FJ, Matsumoto AM, Snyder PJ, Swerdloff RS, Montori VM. Testosterone therapy in adult men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2006 Jun;91(6):1995-2010. [109 references]

Scope

Disease/Condition(s)

Adult androgen deficiency syndromes

Guideline Category
Diagnosis
Evaluation
Management
Screening
Treatment
Clinical Specialty
Endocrinology
Intended Users
Physicians
Guideline Objective(s)

To update the guidelines for the evaluation and treatment of androgen deficiency syndromes in adult men published previously in 2006

Target Population

Adult men with androgen deficiency syndromes

Interventions and Practices Considered

Screening/Evaluation/Diagnosis

  1. Serum testosterone measurement
  2. Morning total testosterone measurement
  3. Confirmatory measurement of morning total testosterone
  4. Free or bioavailable testosterone measurement
  5. Refraining from diagnosis during acute or subacute illness
  6. Luteinizing hormone and follicle-stimulating hormone measurement
  7. Serum prolactin, iron saturation, pituitary function testing, magnetic resonance imaging of the sella turcica, if applicable
  8. Karyotyping to exclude Klinefelter syndrome
  9. Bone mineral density with dual-energy x-ray absorptiometry (DXA)
  10. Screening for androgen deficiency in the general population (specifically not recommended)
  11. Case detection in candidate groups

Treatment/Management

  1. Selection of appropriate candidates for treatment
  2. Testosterone therapy
  3. Monitoring
    • Testosterone levels
    • Hematocrit
    • Bone mineral density
    • Prostate specific antigen (PSA) and digital prostate examination
    • Urological consultation, in select populations
    • Specific side effects and complications
Major Outcomes Considered
  • Accuracy of the diagnosis of androgen deficiency syndrome
  • Differentiation between primary vs. secondary androgen deficiency
  • Appropriateness of testosterone therapy
  • Response to testosterone therapy in terms of secondary sex characteristics, sexual function, sense of well-being, quality of life, muscle mass and strength, and bone mineral density in men with androgen deficiency syndromes
  • Adverse effects and risks of testosterone therapy, including effects on the prostate-related events, cardiovascular events and cardiometabolic risk, and indices of red cell mass

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

Note from the National Guideline Clearinghouse (NGC): The Endocrine Society's Task Force on Androgens in Men requested an updated systematic review of randomized trials and observational studies with long-term follow-up to determine the possible adverse effects of testosterone therapy, including cardiovascular and prostate outcomes (see the "Availability of Companion Documents" field).

Eligibility Criteria

Eligible studies were comparative studies (randomized and nonrandomized) that enrolled adult men with low or low-normal testosterone levels and treated with any testosterone formulation for at least 3 months. The studies had to have a control group without testosterone use and measure the outcomes of interest.

The outcomes of this systematic review are:

  1. Prostate outcomes: the diagnosis of prostate cancer, prostate-specific antigen (PSA) levels above 4 ng/ml or a significant increase in PSA during treatment (defined as PSA increment of >1.4 ng/ml above baseline), a prostatic biopsy, increase in International Prostate Symptom Score (IPSS) greater than 4, acute urinary retention, and a composite prostate endpoint that combines these aforementioned outcomes.
  2. Cardiovascular events and cardiometabolic risk factors: death, coronary events (fatal and nonfatal myocardial infarction, hospitalization for an acute coronary syndrome, coronary revascularization), cerebrovascular events (fatal and nonfatal stroke or transient ischemic attack), peripheral vascular events (new onset claudication, acute arterial occlusion, revascularization procedure), changes in lipid fractions, changes in glucose metabolism (fasting glucose level and new onset of diabetes), and blood pressure. 
  3. Indices of red cell mass (hemoglobin, hematocrit, and incidence of erythrocytosis defined as hematocrit >52%).

Reviewers excluded studies that used androgens other than testosterone as well as studies with simultaneous treatment with other hormones and drugs unless there was a clearly defined treatment arm that received only testosterone treatment. Studies not reporting the outcomes of interest were excluded. Language of publication was not an eligibility criterion.

Study Identification

An expert reference librarian conducted the electronic search with input from study investigators with expertise in systematic reviews. MEDLINE, EMBASE, and Cochrane CENTRAL electronic databases were searched from 2003 through August 2008. Studies published before 2003 were obtained from two published systematic reviews. Because published reviews excluded patients with human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS), the previous search strategy was expanded to cover the period 1981–2004, focusing on studies conducted in this population [exp HIV infections/ or (human adj immune*) or (acquired adj immune*) or AIDS* or HIV]. The detailed strategy is available upon request. To identify additional candidate studies, the reference lists of the eligible primary studies, narrative reviews, and systematic reviews were reviewed, and expert members of the commissioning task force were queried.

Number of Source Documents

The search identified 984 candidate references, of which 51 trials were deemed eligible for inclusion in the review and meta-analysis.

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Quality of the Evidence

+OOO Denotes very low quality evidence

++OO Denotes low quality evidence

+++O Denotes moderate quality evidence

++++ Denotes high quality evidence

Methods Used to Analyze the Evidence
Meta-Analysis of Randomized Controlled Trials
Review of Published Meta-Analyses
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence

Study Selection

Working independently and in duplicate, reviewers screened all abstracts and titles. After obtaining all potentially eligible studies in full text, these reviewers, again working independently and in duplicate, determined eligibility with acceptable chance-adjusted agreement (kappa = 0.85; range, 0.75–0.94). Disagreements were resolved by consensus or arbitration.

Data Collection

Using a standardized data extraction form and working in duplicate, the reviewers abstracted the following descriptive data from each study: description of study participants (age, baseline testosterone levels), and characteristics of treatment and control interventions (testosterone formulation, dose, frequency, route of administration, and treatment duration). The reviewers extracted the outcomes of interest at the longest point of complete follow-up. The reviewers contacted the authors of included studies by e-mail if a clarification of their methods (e.g., randomization and blinding procedures) or results (missing data, e.g., standard deviation [SD]) was needed.

Quality Assessment

The reviewers employed the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to rate the quality of evidence. To assess the methodological quality of randomized trials, the reviewers determined how the randomization sequence was generated, how allocation was concealed, whether there were important imbalances at baseline, which groups were blinded (patients, caregivers, data collectors, outcome assessors, data analysts), what the loss to follow-up rate was (in the intervention and the control arm), whether the analyses were by intention to treat, and how missing outcome data were dealt with. For each study, the reviewers also assessed how the population was selected, the duration and route of testosterone administration, the adequacy of study follow-up, and the funding source. The reviewers assessed the chance-adjusted agreement on study quality using the kappa statistic with disagreements resolved by consensus or arbitration.

Meta-analyses

The reviewers estimated the relative risk (RR) for dichotomous outcomes and the weighted mean difference (WMD) for continuous outcomes pooled across studies using the DerSimonian and Laird random-effects model. The reviewers quantified inconsistency using the I2 statistic, which describes the proportion of heterogeneity across studies that is not due to chance, thus describing the extent of true inconsistency in results across trials. I2 less than 25% and I2 more than 50% reflect small and significant inconsistency, respectively.

Subgroup and Sensitivity Analyses

To explore causes of inconsistency and subgroup-treatment interactions, subgroup analyses were specified a priori according to the following factors:

  1. Participants: age less than 65 or more than 65 yr; total testosterone level at baseline (low if less than 300 ng/dl or 10.4 nmol/l). If total testosterone was not available, then lower limit of normal for bioavailable or free testosterone levels. If neither total nor free testosterone levels were available, then studies were classified according to participant characteristics.
  2. Interventions: testosterone formulation, route of administration, and dose (substitution doses as recommended by The Endocrine Society vs. anything higher).
  3. Outcome characteristic: duration of follow-up (less than 6 months vs. more than 6 months).
  4. Study quality measure: proportion of patients lost to follow-up (10% or less vs. more than 10%), concealment of allocation, blinding of patients, health care professionals, data collectors, and outcome assessors.

In addition, the reviewers conducted sensitivity analyses using Peto odds ratio and different continuity correction factors to determine whether these choices in analysis methods affected the conclusions.

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

Participants

The Androgens in Men Guideline Task Force was composed of a chair, selected by the Clinical Guidelines Subcommittee of The Endocrine Society, five additional experts, a methodologist, and a medical writer.

Evidence

This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe the strength of recommendations and the quality of evidence.

Consensus Process

Consensus of this guideline was guided by systematic reviews of evidence and discussions during in-person group meetings, several conference calls, and e-mail communications.

Rating Scheme for the Strength of the Recommendations

Strength of Recommendations

  • The number 1 indicates a strong recommendation and is associated with the phrase "The Task Force recommends."
  • The number 2 denotes a weak recommendation and is associated with the phrase "The Task Force suggests."
Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
Internal Peer Review
Description of Method of Guideline Validation

The drafts prepared by the Task Force were reviewed successively by The Endocrine Society's Clinical Guidelines Subcommittee, Clinical Affairs Core Committee, and approved by Council. At each stage of review, the Task Force received written comments and incorporated needed changes. Task Force members had final responsibility for and control over content presented in the guideline.

Recommendations

Major Recommendations

Definitions for the levels of evidence (+OOO, ++OO, +++O, and ++++); the strength of the recommendation (1 or 2); and for the difference between a "recommendation" and a "suggestion" are provided at the end of the "Major Recommendations" field.

Diagnosis and Evaluation of Patients with Suspected Androgen Deficiency

The Task Force recommends making a diagnosis of androgen deficiency only in men with consistent symptoms and signs and unequivocally low serum testosterone levels. (1 | +OOO )

The Task Force suggests that clinicians measure serum testosterone level in patients with clinical manifestations shown in Table 1A in the original guideline document. The Task Force suggests that clinicians also consider measuring serum testosterone level when patients report the less specific symptoms and signs listed in Table 1B in the original guideline document. (2 | +OOO)

The Task Force suggests the measurement of morning total testosterone level by a reliable assay as the initial diagnostic test. (2 | +OOO)

The Task Force recommends confirmation of the diagnosis by repeating measurement of total testosterone. (1 | ++OO)

The Task Force suggests measurement of free or bioavailable testosterone level, using an accurate and reliable assay, in some men in whom total testosterone concentrations are near the lower limit of the normal range and in whom alterations of sex hormone binding globulin (SHBG) are suspected. (2 | ++OO)

The Task Force suggests that an evaluation of androgen deficiency should not be made during an acute or subacute illness. (2 | ++OO)

Further Evaluation of Men Deemed Androgen Deficient

The Task Force recommends measurement of serum luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels to distinguish between primary (testicular) and secondary (pituitary-hypothalamic) hypogonadism. (1 | ++OO)

In men with secondary hypogonadism, the Task Force suggests further evaluation to identify the etiology of hypothalamic and/or pituitary dysfunction. This evaluation may include measurements of serum prolactin and iron saturation, pituitary function testing, and magnetic resonance imaging of the sella turcica. (2 | +OOO)

In men with primary testicular failure of unknown etiology, the Task Force suggests obtaining a karyotype to exclude Klinefelter syndrome, especially in those with testicular volume less than 6 ml. (2 | +OOO)

The Task Force suggests measurement of bone mineral density by using dual-energy x-ray absorptiometry (DXA) scanning in men with severe androgen deficiency or low trauma fracture. (2 | +OOO)

Screening for Androgen Deficiency (General Population)

The Task Force recommends against screening for androgen deficiency in the general population. (1 | +OOO)

Case Finding of Androgen Deficiency

The Task Force suggests that clinicians not use the available case-finding instruments for detection of androgen deficiency in men receiving health care for unrelated reasons. (2 | +OOO)

The Task Force suggests that clinicians consider case detection by measurement of total testosterone levels in men with certain clinical disorders, listed in Table 3 in the original guideline document, in which the prevalence of low testosterone levels is high or for whom testosterone therapy is suggested/recommended below. (2 | +OOO)

Treatment of Androgen Deficiency with Testosterone

The Task Force recommends testosterone therapy for symptomatic men with classical androgen deficiency syndromes aimed at inducing and maintaining secondary sex characteristics and at improving their sexual function, sense of well-being, and bone mineral density. (1 | ++OO)

The Task Force recommends against testosterone therapy in patients with breast (1 | +OOO) or prostate cancer. (1 | ++OO)

The Task Force recommends against testosterone therapy without further urological evaluation in patients with palpable prostate nodule or induration or prostate-specific antigen (PSA) 4 ng/ml or PSA 3 ng/ml in men at high risk of prostate cancer, such as African Americans or men with first-degree relatives with prostate cancer. (1 | +OOO)

The Task Force recommends against testosterone therapy in patients with hematocrit above 50%, untreated severe obstructive sleep apnea, severe lower urinary tract symptoms [American Urological Association (AUA)/International Prostate Symptom Score (IPSS) 19], or uncontrolled or poorly controlled heart failure, or in those desiring fertility. (1 | +OOO)

The Task Force suggests initiating testosterone therapy with any of the following regimens, chosen on the basis of the patient's preference, consideration of pharmacokinetics, treatment burden, and cost. (2 | ++OO)

  • 75–100 mg of testosterone enanthate or cypionate administered intramuscularly (IM) weekly, or 150–200 mg administered every 2 weeks.
  • One or two 5-mg nongenital, testosterone patches applied nightly over the skin of the back, thigh, or upper arm, away from pressure areas.
  • 5–10 g of a 1% testosterone gel applied daily over a covered area of nongenital skin (patients should wash hands after application).
  • 30 mg of a bioadhesive buccal testosterone tablet applied to buccal mucosa every 12 hours.
  • Testosterone pellets implanted subcutaneously at intervals of 3 to 6 months; the dose and regimen vary with the formulation used.
  • Oral testosterone undecanoate, injectable testosterone undecanoate, testosterone-in-adhesive matrix patch, and testosterone pellets where available.

Monitoring Strategies and Schedule

The Task Force recommends evaluating the patient 3 to 6 months after treatment initiation and then annually to assess whether symptoms have responded to treatment and whether the patient is suffering any adverse effects, and to check compliance. (1 | +OOO)

The Task Force suggests monitoring testosterone levels 3 to 6 months after initiation of testosterone therapy. The Task Force suggests aiming at achieving serum testosterone levels during treatment in the mid-normal range. In men receiving testosterone enanthate or cypionate, the Task Force suggests aiming for testosterone levels between 400 and 700 ng/dl one week after the injection. (2 | ++OO)

The Task Force recommends determining hematocrit at baseline, at 3 to 6 months, and then annually. If hematocrit is >54%, stop therapy until hematocrit decreases to a safe level, evaluate the patient for hypoxia and sleep apnea, and reinitiate therapy at a reduced dose. (1 | +OOO)

The Task Force suggests repeating bone mineral density of the lumbar spine, femoral neck, and hip after 1 to 2 years of testosterone therapy in hypogonadal men with osteoporosis or low trauma fracture. (2 | +OOO)

In men 40 years of age or older who have a baseline PSA >0.6 ng/ml, the Task Force recommends digital examination of the prostate and PSA measurement before initiating treatment, at 3 to 6 months, and then in accordance with evidence-based guidelines for prostate cancer screening, depending on the age and race of the patient. (1 | +OOO)

The Task Force recommends that clinicians obtain urological consultation if there is: (1 | +OOO)

  • An increase in serum or plasma PSA concentration greater than 1.4 ng/ml within any 12-month period of testosterone treatment.
  • A PSA velocity of more than 0.4 ng/ml·yr using the PSA level after 6 months of testosterone administration as the reference. PSA velocity should be used only if there are longitudinal PSA data for more than 2 years.
  • Detection of a prostatic abnormality on digital rectal examination.
  • American Urological Association/International Prostate Symptom Score >19.

The Task Force recommends evaluation for symptoms and signs of formulation-specific adverse events at each visit: (1 | +OOO)

  • Injectable testosterone esters: Inquire about fluctuations in mood or libido, and cough after injection, and evaluate hematocrit to detect excessive erythrocytosis, especially in older patients.
  • Testosterone patch: Look for signs of skin reaction at the application site.
  • Testosterone gels: Advise patients to cover the application site with clothing and wash the skin before having skin-to-skin contact, because gels leave a residue of testosterone on the skin that can be transferred to a woman or child who comes in close contact.
  • Buccal testosterone tablets: Inquire about alterations in taste and examine gums and oral mucosa for irritation.

Testosterone Therapy in Men with Sexual Dysfunction

The Task Force suggests that clinicians offer testosterone therapy to men with low testosterone levels and low libido to improve libido (2 | ++OO) and to men with erectile dysfunction (ED) who have low testosterone levels after evaluation of underlying causes of ED and consideration of established therapies for ED. (2 | +OOO)

Older Men with Low Serum Testosterone Concentration

The Task Force recommends against a general policy of offering testosterone therapy to all older men with low testosterone levels. (1 | +OOO)

The Task Force suggests that clinicians consider offering testosterone therapy on an individualized basis to older men with low testosterone levels on more than one occasion and clinically significant symptoms of androgen deficiency, after explicit discussion of the uncertainty about the risks and benefits of testosterone therapy. (2 | +OOO)

Patients with Chronic Illness and Low Testosterone Levels

The Task Force suggests that clinicians consider short-term testosterone therapy as an adjunctive therapy in human immunodeficiency virus (HIV)-infected men with low testosterone levels and weight loss to promote weight maintenance and gains in lean body mass (LBM) and muscle strength. (2 | ++OO)

Glucocorticoid-Treated Men

The Task Force suggests that clinicians offer testosterone therapy to men receiving high doses of glucocorticoids who have low testosterone levels to promote preservation of lean body mass and bone mineral density. (2 | ++OO)

Definitions:

Strength of Recommendations

1 - Indicates a strong recommendation and is associated with the phrase "The Task Force recommends."

2 - Denotes a weak recommendation and is associated with the phrase "The Task Force suggests."

Evidence Grading

+OOO Denotes very low quality evidence

++OO Denotes low quality evidence

+++O Denotes moderate quality evidence

++++ Denotes high quality evidence

Clinical Algorithm(s)

The original guideline document contains a clinical algorithm for "An approach for the diagnostic evaluation in adult men suspected of having androgen deficiency."

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The quality of the supporting evidence is identified and graded for each recommendation (see the "Major Recommendations" field).

In the original guideline document, linked to each recommendation is a description of the evidence, values that panelists considered in making the recommendation, and in some instances remarks, a section in which panelists offer technical suggestions for dosing and monitoring. These technical comments reflect the best available evidence applied to a typical patient. Often, this evidence comes from the unsystematic observations of the panelists and their values and preferences; therefore, these remarks should be considered suggestions.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Benefits of testosterone therapy for androgen deficiency syndrome in adult males have been found to include the induction and maintenance of secondary sex characteristics, and improvements in sexual function, sense of well-being, muscle mass and strength and bone mineral density. A full discussion of these benefits can be found in the original guideline document.

Special Populations - Human Immunodeficiency Virus (HIV)-Infected Men

In HIV-infected men with low testosterone levels, short-term testosterone therapy as adjunctive therapy and weight loss may promote weight maintenance and gains in lean body mass and muscle strength.

Potential Harms

Potential Adverse Effects of Testosterone Replacement

Adverse events for which there is evidence of association with testosterone administration:

  • Erythrocytosis
  • Acne and oily skin
  • Detection of subclinical prostate cancer
  • Growth of metastatic prostate cancer
  • Reduced sperm production and fertility

Uncommon adverse events for which there is weak evidence of association with testosterone administration:

  • Gynecomastia
  • Male pattern balding (familial)
  • Growth of breast cancer
  • Induction or worsening of obstructive sleep apnea

Formulation-specific adverse effects:

  • Intramuscular injections of testosterone enanthate, cypionate or undecanoate
    • Fluctuation in mood or libido
    • Pain at injection site
    • Excessive erythrocytosis (especially in older patients)
    • Coughing episodes immediately after the intramuscular injection*
  • Transdermal patches
    • Frequent skin reactions at application site
  • Transdermal gel
    • Potential risk for testosterone transference to partner or another person who is in close contact (need to remind patient to cover application sites with clothing and to wash skin and hands with soap before having skin-to-skin contact with another person)
    • Skin irritation
  • Buccal testosterone tablets
    • Alterations in taste
    • Irritation of gums
  • Pellet implants
    • Infection, expulsion of pellet
  • Oral tablets
    • Effects on liver and cholesterol (methyltestosterone)#

* The mechanism of cough, which has been reported rarely after intramuscular injections of testosterone undecanoate and even more rarely after testosterone enanthate and cypionate, is unknown, but it has been attributed to oil embolization.

# Liver toxicity has been reported mostly with oral 17-alpha alkylated androgens. The frequency of skin reactions is higher with the testosterone patch than with the transdermal gels.

Contraindications

Contraindications

Conditions in which testosterone administration is associated with a high risk of adverse outcome and in which testosterone should not be administered:

  • Very high risk of serious adverse outcomes
    • Metastatic prostate cancer
    • Breast cancer
  • Moderate to high risk of adverse outcomes
    • Unevaluated prostate nodule or induration
    • Prostate specific antigen (PSA) >4 ng/ml (>3 ng/ml in individuals at high risk for prostate cancer, such as African-Americans or men with first-degree relatives who have prostate cancer)
    • Hematocrit >50%
    • Severe lower urinary tract symptoms associated with benign prostatic hypertrophy as indicated by American Urological Association/International Prostate Symptom Score (AUA/IPSS) >19
    • Uncontrolled or poorly controlled congestive heart failure

Qualifying Statements

Qualifying Statements
  • Clinical Practice Guidelines are developed to be of assistance to endocrinologists and other health care professionals by providing guidance and recommendations for particular areas of practice. The Guidelines should not be considered inclusive of all proper approaches or methods, or exclusive of others. The Guidelines cannot guarantee any specific outcome, nor do they establish a standard of care. The Guidelines are not intended to dictate the treatment of a particular patient. Treatment decisions must be made based on the independent judgment of health care providers and each patient's individual circumstances.
  • The Endocrine Society makes no warranty, express or implied, regarding the Guidelines and specifically excludes any warranties of merchantability and fitness for a particular use or purpose. The Society shall not be liable for direct, indirect, special, incidental, or consequential damages related to the use of the information contained herein.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Clinical Algorithm
Patient Resources
Staff Training/Competency Material
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
Living with Illness
IOM Domain
Effectiveness

Identifying Information and Availability

Bibliographic Source(s)
Bhasin S, Cunningham GR, Hayes FJ, Matsumoto AM, Snyder PJ, Swerdloff RS, Montori VM, Task Force, Endocrine Society. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2010 Jun;95(6):2536-59. [151 references] PubMed External Web Site Policy
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2006 Jun (revised 2010 Jun)
Guideline Developer(s)
The Endocrine Society - Professional Association
Source(s) of Funding

The Endocrine Society

Guideline Committee

The Androgens in Men Guideline Task Force

Composition of Group That Authored the Guideline

Task Force Members: Shalender Bhasin (Chair); Glenn R. Cunningham; Frances J. Hayes; Alvin M. Matsumoto; Peter J. Snyder; Ronald S. Swerdloff; Victor M. Montori

Financial Disclosures/Conflicts of Interest

Shalender Bhasin, M.D. (Chair) — Consultation or Advisement: GlaxoSmithKline (GSK), Merck; Grant or Other Research Support: Abbott Laboratories, Ligand, Merck; Financial or Business/Organizational Interests: American Board of Internal Medicine

Glenn R. Cunningham, M.D. — Consultation or Advisement: Clarus, Columbia Lab, GSK, Endo Pharmaceuticals, Abbott Laboratories; Grant or Other Research Support: Abbott Laboratories; Columbia Lab, GSK; Speakers List: Columbia Lab, Endo Pharmaceuticals, Abbott Laboratories; Financial or Business/Organizational Interests: UpToDate; Significant Financial Interest or Leadership Position: none declared

Frances J. Hayes, M.B., FRCPI — Consultation or Advisement: Auxilium Pharmaceuticals, GSK, New England Research Institute; Speakers Bureau for Abbott Laboratories; Financial or Business/Organizational Interests: none declared; Significant Financial Interest or Leadership Position: none declared

Alvin M. Matsumoto, M.D. — Consultation or Advisement: Abbott Laboratories, Merck, Endo Pharmaceuticals, Tokai; Grant or Other Research Support: GSK, Abbott Laboratories; Financial or Business/Organizational Interests: UpToDate, U.S. Anti-Doping Agency/PCC; Significant Financial Interest or Leadership Position: none declared

Peter J. Snyder, M.D. — Consultation or Advisement: none declared; Grant or Other Research Support: Abbott Laboratories; Financial or Business/Organizational Interests: Abbott Laboratories, UpToDate; Significant Financial Interest or Leadership Position: UpToDate

Ronald S. Swerdloff, M.D. — Consultation or Advisement: Clarus, Abbott Laboratories, Endo Pharmaceuticals; Grant or Other Research Support: Actelion Pharma, ARYx Therapeutics, Inc., Auxilium, Bayer Corp., Besins/Ascend, Bristol-Myers Squibb, Clarus, Columbia, Corcept, GSK, Eli Lilly &Co., MacroChem Corp., Organon, Schering AG, Abbott Laboratories; Financial or Business/Organizational Interests: none declared; Significant Financial Interest or Leadership Position: none declared

*Victor M. Montori, M.D. — Financial or Business/Organizational Interests: none declared; Significant Financial Interest or Leadership Position: none declared

* Evidence-based reviews for this guideline were prepared under contract with The Endocrine Society.

Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Bhasin S, Cunningham GR, Hayes FJ, Matsumoto AM, Snyder PJ, Swerdloff RS, Montori VM. Testosterone therapy in adult men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2006 Jun;91(6):1995-2010. [109 references]

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) from The Endocrine Society External Web Site Policy.

Print copies: Available from The Endocrine Society, Phone: (301) 941.0210; Email: Societyservices@endo-society.org

Availability of Companion Documents

The following is available:

  • Fernandez-Balsells MM, Murad MH, Lane M, Lampropulos JF, Albuquerque F, Mullan RJ, Agrwal N, Elamin MB, Gallegos-Orozco JF, Wang AT, Erwin PJ, Bhasin S, and Montori VM. Adverse effects of testosterone therapy in adult men: a systematic review and meta-analysis. J Clin Endocrinol Metab. 2010 Jun;95(6).

In addition, a version of this guideline with Continuing Medical Education (CME) is available for purchase through The Endocrine Society Web site External Web Site Policy.

Print copies: Available from The Endocrine Society, Phone: (301) 941.0210; Email: Societyservices@endo-society.org

Patient Resources

The following is available:

  • Patient guide to testosterone therapy in adult men with androgen deficiency syndromes. The Hormone Foundation. 2010 Jun. 2 pg. Electronic copies: Available from The Hormone Foundation Web site External Web Site Policy.

Print copies: Available from The Endocrine Society, Phone: (301) 941.0210; Email: Societyservices@endo-society.org

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status

This NGC summary was completed by ECRI on Aug 1, 2006. The information was verified by the guideline developer on August 29, 2006. This summary was updated by ECRI Institute on May 15, 2009 following the U.S. Food and Drug Administration advisory on Testosterone gel products. This NGC summary was updated by ECRI Institute on August 19, 2010. The updated information was verified by the guideline developer on September 16, 2010.

Copyright Statement

This is an author manuscript copyrighted by The Endocrine Society. This may not be duplicated or reproduced, other than for personal use or within the rule of "Fair Use of Copyrighted Materials" (section 107, Title 17, U.S. Code) without permission of the copyright owner, The Endocrine Society. From the time of acceptance following peer review, the full text of this manuscript is made freely available by The Endocrine Society at http://www.endo-society.org/guidelines/Current-Clinical-Practice-Guidelines.cfm External Web Site Policy.

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