Testosterone replacement therapy (TRT) can help men with hypogonadism, or low testosterone, return to healthy testosterone levels. There are several ways to administer TRT, including gels, injections, and pellets.
Testopel® is a long-acting form of TRT. It’s administered through subcutaneous implantation — meaning a medical professional places small pellets containing testosterone under your skin.
The Food and Drug Administration (FDA) approved Testopel® in 1972, but it didn’t become a widespread treatment until years later. Each Testopel® pellet contains 75mg of testosterone.
While there is no current FDA approved generic version of Testopel, there are compounding pharmacies that may be able to provide a compounded version of testosterone pellets. These pharmacies are not FDA approved.
The following information will give you a complete overview of Testopel®, with information on its pharmacokinetics (how it moves through the body), its effectiveness, its safety, and other practical considerations. This information is intended for doctors, other healthcare professionals, and patients who want to learn more about Testopel®.
Understanding Hypogonadism and the Role of Testosterone
Before diving into Testopel, it’s important to understand the condition it’s designed to treat: hypogonadism. Hypogonadism is a condition in which the body doesn’t produce enough testosterone.
Defining Hypogonadism
There are two main types of hypogonadism:
- Primary hypogonadism: This occurs when the testicles themselves are failing to produce enough testosterone, potentially due to issues with blood flow to the testes.
- Hypogonadotropic hypogonadism: This type is caused by problems with the hypothalamus or pituitary gland, which control the testicles.
Importance of Testosterone
Testosterone is a crucial hormone in men, playing a key role in many bodily functions.
Physiological Effects: Testosterone is essential for male sexual development, maintaining muscle mass and bone density, and contributing to overall well-being.
Symptoms of Testosterone Deficiency: When testosterone levels are low, men may experience fatigue, decreased sex drive, erectile dysfunction, and changes in mood, but there are ways to boost testosterone naturally.
Testopel: Composition, Mechanism, and Pharmacokinetics
Let’s dig into what Testopel is made of, how it works, and how your body processes it.
Composition of Testopel
Each Testopel pellet contains:
- Active ingredient: Testosterone (75mg per pellet)
- Inactive ingredients: Stearic acid and polyvinylpyrrolidone
The pellets are small, about 3.2mm in diameter and roughly 9mm long.
Mechanism of Action
Testopel isn’t a cream or a shot. The pellets are implanted under your skin (subcutaneously), usually in the upper part of your buttock. Once they’re in, they slowly release testosterone into your bloodstream over several months.
Pharmacokinetics of Testopel
Here’s a breakdown of how the testosterone from Testopel gets absorbed and how long it lasts:
- Absorption Rate: About one-third of the testosterone is absorbed in the first month, one-quarter in the second month, and one-sixth in the third month. So, it’s a gradual release.
- Duration of Effect: Typically, the effects last for 3-4 months, but in some cases, it can stretch out to 6 months.
- Half-life: The therapeutic half-life (how long it takes for half of the drug to be eliminated from your system) is around 2.5 months.
This slow and steady release is designed to keep your testosterone levels more stable compared to other methods of testosterone replacement.
Testopel Dosage and Administration
If your doctor prescribes Testopel, here’s what you can expect in terms of dosage and how the treatment is administered.
Dosage Guidelines
The starting dose typically ranges from 150mg to 450mg, which is equal to 2 to 6 pellets. These pellets are usually implanted every 3 to 6 months.
Your doctor will adjust your dosage based on how your body responds to the treatment and your testosterone levels, and you may also consider whether certain foods, such as eggs, can increase testosterone. It’s also worth noting that guys with a BMI under 25 may get a bigger boost in testosterone compared to guys with a BMI over 25.
Administration Technique
The pellets are implanted just under the skin (subcutaneously) in the upper outer part of your buttock.
To insert the pellets, the doctor will make a small cut and use a tool called a trocar.
It’s important to get this done by someone who knows what they’re doing. Studies have shown that extrusion and infection rates are lower at centers where the implanter has plenty of experience.
Efficacy of Testopel in Treating Hypogonadism
So, how well does Testopel actually work for treating low testosterone? Let’s dive into what the research says.
Clinical Studies
Several studies have looked at the effectiveness of testosterone pellets, including Testopel, in treating hypogonadism. Here’s a quick rundown:
- Handelsman’s Studies: These studies, some of the earliest, investigated the use of testosterone pellets made by Organon.
- Cavender’s Retrospective Analysis: This was a look back at how Testopel performed at a single clinic.
- Kaminetsky’s Prospective Evaluation: This was a study that looked forward to see how Testopel worked over time.
- McCullough’s Multi-Institutional Study: This study looked at Testopel results across multiple clinics.
- Pastuszak’s Follow-up Study: This study followed 273 men who were being treated with Testopel to see their long-term outcomes.
Outcomes
What did these studies find?
- Testosterone Levels: Pellet implantation, in general, does a good job of getting testosterone levels back into the normal range. Studies showed that between 400 and 1200 mg of pellets could keep testosterone in the “eugonadal” range for 4-6 months. “Eugonadal” just means normal testosterone levels for men.
- Symptom Improvement: Men in these studies also reported feeling better overall. They had improvements in things like fatigue, their sex drive (libido), and their mood.
In short, the research suggests Testopel can be an effective way to restore testosterone levels and improve the symptoms of hypogonadism.
Potential Risks, Side Effects, and Complications
Like any medical treatment, Testopel comes with potential risks and side effects. It’s crucial to discuss these with your doctor to make an informed decision.
Common Side Effects
Some of the more commonly reported side effects include:
- Injection Site Reactions: You might experience pain, bruising, or swelling at the spot where the pellets were implanted.
- Skin Reactions: Acne and oily skin are also frequently reported.
- Mood Changes: Some men experience irritability or anxiety.
- Gynecomastia: This refers to breast enlargement.
Serious Adverse Reactions
While less common, some more serious adverse reactions have been associated with testosterone replacement therapy, including Testopel. These include:
- Cardiovascular Events: There’s a potential increased risk of major adverse cardiovascular events (MACE) like heart attack or stroke.
- Venous Thromboembolic Events (VTE): Testosterone products can increase the risk of blood clots in the veins (VTE).
- Prostate Issues: Testopel could potentially lead to prostate enlargement or worsen symptoms of benign prostatic hyperplasia (BPH).
- Sleep Apnea: If you already have sleep apnea, Testopel might make it worse.
Complications
Specific to Testopel, two potential complications can occur:
- Extrusion: This means the pellets can be expelled from the implantation site. Early studies showed a high extrusion rate (around 40%), but more experienced centers report much lower rates (less than 1%).
- Infection: There’s a risk of infection at the implantation site. One retrospective analysis reported an infection rate of about 0.3%.
Monitoring and Management
Because of these potential risks, regular monitoring is essential. This typically includes:
- Monitoring your testosterone levels to ensure they’re within the desired range.
- Checking your hematocrit (red blood cell count).
- Monitoring your prostate-specific antigen (PSA) levels.
It’s also important to address any side effects that you experience with appropriate interventions, as directed by your doctor. Don’t hesitate to report any unusual symptoms or concerns to your healthcare provider.
Drug Interactions and Contraindications
As with any medication, Testopel may interact with other drugs you’re taking. It’s also not appropriate for certain people to take. Here’s what you should know:
Drug Interactions
- Anticoagulants: Testosterone may amplify the effects of blood thinners like coumadin.
- Oxyphenbutazone: Testopel may increase levels of oxyphenbutazone in your system.
Contraindications
You shouldn’t take Testopel if any of the following apply to you:
- Prostate Cancer: Men who have or are suspected of having prostate cancer should not use testosterone.
- Breast Cancer: Testosterone is not for men who have breast cancer.
- Pregnancy: Testosterone is never appropriate for women who are pregnant or may become pregnant.
This list isn’t exhaustive. Talk to your doctor about all medications and health conditions before starting Testopel.
Testopel vs. Other Testosterone Delivery Methods
Testopel isn’t the only way to get testosterone into your system. Here’s how it stacks up against other common methods:
Comparison with Gels
Testosterone gels, like AndroGel, need to be applied every day. On the other hand, Testopel pellets are a “set it and forget it” solution that lasts for months.
Gels also come with a transfer risk. If the gel comes into contact with someone else’s skin, they could absorb the testosterone, which could be harmful.
Comparison with Injections
Testosterone injections typically need to be administered once a week or every other week.
Injections can also cause your testosterone levels to spike and then crash, which some people find unpleasant. Testopel is designed to release testosterone at a steady rate.
Advantages of Pellets
The main benefits of Testopel are convenience, since you don’t have to think about it as often, and potentially more stable hormone levels.
Disadvantages of Pellets
Getting Testopel requires a minor surgical procedure to implant the pellets under your skin.
Also, it’s harder to adjust the dosage with pellets compared to gels or injections. Once they’re in, they’re in!
Special considerations: abuse, age-related hypogonadism, and pediatric use
Testosterone abuse
Testosterone replacement is sometimes misused. Please note that taking testosterone without a prescription from a healthcare provider can lead to serious side effects, including heart problems and mental health issues.
It’s also important to remember that Testopel is not intended to improve athletic performance.
Age-related hypogonadism
If you’re experiencing what you believe is age-related hypogonadism, talk to your doctor about whether Testopel is right for you. The safety and effectiveness of this drug haven’t been established for this specific condition.
Pediatric use
Because Testopel impacts hormone levels, it should be used with caution in young people with delayed puberty.
If your child or teen is taking Testopel, their doctor should regularly monitor their bone age to ensure normal development.
In Closing
Testopel is a long-acting form of testosterone replacement therapy (TRT) for men who don’t produce enough testosterone on their own. It offers some advantages, such as convenience and more stable testosterone levels, compared to other forms of TRT.
But it’s important to remember that TRT isn’t one-size-fits-all. The right dosage and administration schedule should be determined by you and your doctor, based on your individual needs and how your body responds.
Researchers are still studying the long-term effects of Testopel, especially when it comes to heart health. Future studies may also explore whether combining Testopel with other therapies or using different dosing strategies could improve its effectiveness.
Ultimately, the key to successful TRT with Testopel is responsible use. That means carefully selecting patients who are truly good candidates, closely monitoring their progress, and using the medication only under the guidance of a qualified healthcare professional.