Testosterone Therapy for Low Testosterone
(PATH Trial)
Recruiting in Palo Alto (17 mi)
Overseen ByRobert R Edwards, PhD
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Brigham and Women's Hospital
Must be taking: Opioid analgesics
Must not be taking: Testosterone
Disqualifiers: Prostate cancer, Organic hypogonadism, Bipolar, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?The aim of this trial is to evaluate whether testosterone replacement results in greater improvement in pain perception, pain tolerance, sexual function, fatigue, and quality of life when compared with placebo in men with chronic spinal pain treated with opioids who have opioid-induced hypogonadism (low testosterone).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must not have used testosterone in the past 6 months.
What data supports the effectiveness of the drug Testosterone undecanoate for low testosterone?
Research shows that Testosterone undecanoate is effective in treating male hypogonadism (a condition where the body doesn't produce enough testosterone) by significantly increasing plasma testosterone levels, improving symptoms like decreased energy and libido, and providing a convenient oral option that may enhance patient compliance.
12345Is testosterone therapy generally safe for humans?
Testosterone therapy, particularly with testosterone undecanoate, has been shown to have a good safety profile in humans. Long-term studies indicate no significant adverse effects on liver function, lipid profiles, or prostate health, and it avoids the 'roller coaster' effects of traditional testosterone injections.
14567What makes testosterone cypionate and testosterone undecanoate unique for treating low testosterone?
Testosterone cypionate and testosterone undecanoate are unique because they offer different administration routes and dosing schedules compared to other testosterone therapies. Testosterone cypionate is typically injected every 1-2 weeks, while testosterone undecanoate can be administered less frequently, potentially improving convenience and adherence for patients.
89101112Eligibility Criteria
This trial is for men over 18 with chronic back pain treated with opioids, leading to low testosterone levels. They must have been on opioid painkillers for at least six months and be willing to consent. Men with prostate or breast cancer, certain mental health conditions, recent heart issues, severe kidney or liver disease, or specific metallic implants cannot participate.Inclusion Criteria
I have been using opioid painkillers for at least 6 months.
Ability and willingness to provide informed consent
I have long-term back pain not caused by cancer.
+5 more
Exclusion Criteria
I have not used testosterone in the last 6 months.
Your blood has more red blood cells than it should.
Your prostate-specific antigen (PSA) level is higher than 4 ng/mL if you are Caucasian, or higher than 3 ng/mL if you are African-American.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive testosterone or placebo for 6 months to evaluate improvements in pain perception, sexual function, fatigue, and quality of life
6 months
Baseline, 3 months, and 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests if testosterone replacement (Testosterone Undecanoate) can better improve pain perception, tolerance, sexual function, fatigue and life quality compared to a placebo in these men.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TestosteroneExperimental Treatment1 Intervention
Intramuscular injections of testosterone undecanoate 750 mg.
Group II: PlaceboPlacebo Group1 Intervention
Intramuscular injections of placebo.
Testosterone cypionate is already approved in United States for the following indications:
🇺🇸 Approved in United States as Depo-Testosterone for:
- Primary hypogonadism
- Hypogonadotropic hypogonadism
- Delayed puberty
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Brigham and Women's HospitalBoston, MA
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Who Is Running the Clinical Trial?
Brigham and Women's HospitalLead Sponsor
References
Testosterone undecanoate in the treatment of male hypogonadism. [2014]Testosterone undecanoate (TU) represents an exciting new testosterone replacement therapy for hypogonadal men due to its convenient dosing schedule and favorable pharmacokinetic and safety profiles.
Safety Aspects and Rational Use of Testosterone Undecanoate in the Treatment of Testosterone Deficiency: Clinical Insights. [2023]Testosterone deficiency is diagnosed by a serum total testosterone level below 300 ng/dL in combination with symptoms such as decreased energy and libido. These symptoms can be ameliorated by restoring serum testosterone to the physiologic range with testosterone therapy (TT). There are numerous forms of testosterone therapy, such as injectable, transdermal, nasal, and subcutaneous applications. There are also multiple formulations of injection, such as testosterone cypionate, testosterone enanthate, and testosterone undecanoate. Testosterone undecanoate (TU) is a long-acting ester formulation of testosterone that can be provided in an injectable or oral form. Oral testosterone undecanoate is marketed as Andriol, Jatenzo, Tlando, and Kyzatrex. Oral TU provides a convenient option for many patients, which may increase compliance with TT. Injectable testosterone undecanoate is marketed as Aveed and Nebido. Injectable TT remains the most cost-effective therapeutic option and is appropriate for most patients as an initial therapy. This review describes the pharmacokinetics of these testosterone undecanoate products and provides a guide for prescribers using these medications. While many forms of testosterone are appropriate for TT, a patient-centered discussion focused on goals of care should best guide physician prescription of these medications.
Testosterone Replacement Therapy: A Narrative Review with a Focus on New Oral Formulations. [2023]Male hypogonadism affects 10-30% of the male population and is often under-recognized and under-treated. Different replacement formulations exist, each with specific benefits and limitations. These replacements include gels, patches and short- and long-acting injectables. JATENZO® (oral testosterone undecanoate; Clarus Therapeutics Inc., Northbrook, IL, US) is the first oral formulation of testosterone approved by the US Food and Drug Administration. TLANDO® (oral testosterone undecanoate; Lipocine Inc., Salt Lake City, UT, US), another oral testosterone formulation, has also recently been approved by the US Food and Drug Administration. Based on unique chemistry using a self-emulsifying drug delivery system and lymphatic absorption, JATENZO and TLANDO address some of the limitations of other dosing routes while providing a safe option without evidence of liver dysfunction. This review discusses various testosterone treatment options, focusing on the role and pharmacokinetics of the new oral formulations.
Two-Year Analysis of a New Oral Testosterone Undecanoate (TU) Formulation in Hypogonadal Men: Efficacy, Impact on Psychosexual Function, and Safety. [2023]Long-term data evaluating the efficacy and safety of oral testosterone undecanoate (oral TU; JATENZO) in adult hypogonadal men provides important information for healthcare professionals who prescribe testosterone replacement therapy (TRT).
Clinical efficacy of testosterone undecanoate in male hypogonadism. [2019]Testosterone undecanoate (Restandol, Organon Laboratories Ltd) dissolved in oleic acid, was administered orally to seventy-six hypogonadal males for three consecutive 3-week periods and the subjective clinical response assessed by a standard interview. Plasma testosterone and testosterone undecanoate levels were determined by radioimmunoassay before the study and after 3, 6 and 9 weeks treatment. The treatment was effective in sixty of the sixty-six patients who completed the trial. Ten patients did not complete the trial; two for reasons unrelated to the drug and eight because of side effects, mainly gastro-intestinal. There was a significant rise in plasma testosterone levels during treatment and a positive correlation between plasma testosterone and testosterone undecanoate levels. Testosterone undecanoate is a potentially valuable drug for the oral treatment of male hypogonadism.
Testosterone depot injection in male hypogonadism: a critical appraisal. [2021]Testosterone compounds have been available for almost 70 years, but the pharmaceutical formulations have been less than ideal. Traditionally, injectable testosterone esters have been used for treatment, but they generate supranormal testosterone levels shortly after the 2- to 3-weekly injection interval and then testosterone levels decline very rapidly, becoming subnormal in the days before the next injection. The rapid fluctuations in plasma testosterone are subjectively experienced as disagreeable. Testosterone undecanoate is a new injectable testosterone preparation with a considerably better pharmacokinetic profile. After 2 initial injections with a 6-week interval, the following intervals between two injections are almost always 12-weeks, amounting eventually to a total of 4 injections per year. Plasma testosterone levels with this preparation are nearly always in the range of normal men, so are its metabolic products estradiol and dihydrotestosterone. The "roller coaster" effects of traditional parenteral testosterone injections are not apparent. It reverses the effects of hypogonadism on bone and muscle and metabolic parameters and on sexual functions. Its safety profile is excellent due to the continuous normalcy of plasma testosterone levels. No polycythemia has been observed, and no adverse effects on lipid profiles. Prostate safety parameters are well within reference limits. There was no impairment of uroflow. Testosterone undecanoate is a valuable contribution to the treatment options of androgen deficiency.
A ten-year safety study of the oral androgen testosterone undecanoate. [2014]Testosterone undecanoate (Andriol) is an oral androgen that provides the hypogonadal patient with the unmodified testosterone molecule. It was introduced in the mid-1970s. This is a report on the safety of this oral androgen. Of 35 men originally included in the study, 33 could be followed up for a minimum of 10 years. In them no alteration in the biochemical parameters of liver function could be detected. Upon annual measurements (7-9 hours after ingestion of testosterone undecanoate), serum levels of testosterone ranged between 5.4 +/- 1.9 and 6.5 +/- 1.9 nmol/L (normal range 8-24) and of 5 alpha-dihydrotestosterone between 3.2 +/- 1.8 and 3.5 +/- 1.7 nmol/L (normal range 0.8-2.5). These levels remained constant during the study period, indicating that there is no increased hepatic enzymatic breakdown of the androgen over time. Eight men were older than 50 years at the start of the study. Over the 10-year period in two of them a mild reduction in urine flow was measured, whereas in the other six this could not be demonstrated. Digital examination of the prostate did not reveal signs of prostate tumors. Testosterone undecanoate appears to be a safe oral androgen. A yearly checkup of the patient on therapy with this androgen seems adequate.
Full dose, reduced dose or discontinuation of etanercept in rheumatoid arthritis. [2022]The aim of the Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Patients Who Have Achieved a Stable Low Disease Activity-State study was to investigate the effect of etanercept (ETN) dose maintenance, reduction or withdrawal on patients with rheumatoid arthritis (RA) who had already achieved stable low disease activity (LDA) on ETN 50 mg+methotrexate (MTX).
Optimal methotrexate dose is associated with better clinical outcomes than non-optimal dose in daily practice: results from the ESPOIR early arthritis cohort. [2022]Although methotrexate (MTX) is the consensual first-line disease-modifying antirheumatic drug (DMARD) for rheumatoid arthritis (RA), substantial heterogeneity remains with its prescription and dosage, which are often not optimal.
[Guidelines for prescribing and monitoring biologic therapies in juvenile idiopathic arthritis]. [2013]The Pediatric RheumatologyWorking Group of the Portuguese Society of Rheumatology recommends the use of biological treatments in children with polyarticular course Juvenile Idiopathic Arthritis (JIA) with active disease (5 or more active joints) refractory to subcutaneous or intramuscular methotrexate (MTX) 15 mg/m(2)/week during 3 to 6 months. If toxicity occurs, or if there is contraindication for the use of MTX in this optimum dose, biological treatment can be started, as a first option, or the use of other conventional Disease ModifyingAnti Rheumatic Drug (DMARD) either alone or in combination with MTX might be considered. Prior to starting treatment, children should be screened for latent tuberculosis through clinical evaluation, chest X ray and PPD skin test. The suspension of the biological treatment should be considered if the American College of Rheumatology (ACR) definition of improvement in JIA is not fulfilled in two consecutive visits 3 months apart. Etanercept is the only biological agent currently approved for JIA in Portugal. In refractory cases the use of infliximab is accepted, in accordance with preliminary published evidence. In case of systemic manifestations of JIA refractory to conventional treatment, anakinra can be considered.
Methotrexate as the "anchor drug" for the treatment of early rheumatoid arthritis. [2022]The two major advances over the 1990s in the treatment of rheumatoid arthritis (RA) were a shift in strategy from a "pyramid", in which disease modifying anti-rheumatic drugs (DMARDs) were deferred for several years, to the early aggressive use of DMARDs and widespread acceptance of methotrexate as the DMARD with the most long-term effectiveness and safety. Methotrexate courses are continued far longer than those of any other DMARD, an excellent indicator of greater effectiveness and safety. In one recent series, methotrexate was the first DMARD used in more than 80% of patients with RA. Studies which document the superiority of combinations of methotrexate with biological agents to methotrexate monotherapy select for only a minority of contemporary patients with RA who have severe disease activity and incomplete responses to methotrexate. In one locale, only 5% of patients met criteria for the Anti-Tumor Necrosis Factor Trial in RA with Concomitant Therapy (ATTRACT) trial and only 30% met the criteria for the Early Rheumatoid Arthritis (ERA) trial. In studies comparing methotrexate directly with biological agents, the biological agents have greater efficacy in patients with very severe disease, but the best results are seen in patients who take a combination of methotrexate and biologic agents. These data establish that methotrexate is the anchor drug and probably should be the first DMARD used in the majority of patients with RA at this time.
The methotrexate therapeutic response in rheumatoid arthritis. [2013]Methotrexate (MTX) is used frequently as a disease modifying antirheumatic drug (DMARD) for rheumatoid arthritis (RA), and patients tend to continue taking this drug for longer periods than alternative single agents. The shape of the therapeutic response beyond one or 2 years, however, has not been fully studied. We examined the properties of the pure MTX "therapeutic segment," that period that begins with start of MTX and terminates when MTX is discontinued or another DMARD is added, by observational study.