Testosterone pellets under the skin

[Guest guest]

Hello Everyone:

I am a new member and wanted to find out if anyone has used testosterone

pellets. They last a lot longer than any other option and I am considering it

since it is FDA approved. Any thoughts?

..

From http://www.medscape.com/viewarticle/550321_6

Subcutaneous Testosterone Implants (T Pellets/Depot T)

Pharmacologic Profile

Testosterone has also been formulated as fused cylindrical crystalline implants

for TRT (Testopel®, Bartor Pharmaceuticals, Rye, New York).

T pellets serve as a nearly ideal depot, maintaining normal serum levels of T

for months. Once implanted, T pellets form a slowly dissolving subdermal depot

with zero-order release kinetics, such that T absorption is complete or nearly

complete by treatment day 189.[62, 63] T pellets have among the longest

durations of biologic activity among all forms of TRT, with a mean residence

time of 87 days and a half-life of 70.8 days.[63] Approximately 1.18 mg of T is

released from each 200 mg pellet daily.

Clinical Studies

In a study involving 50 hypogonadal men (ages 18–61 years) with serum T<104

ng/dl (mean T = 33.7 ng/dl), a European group implanted six 200 mg T pellets in

each patient.[63] After implantation, serum T peaked at ~1326 ng/dl within 30

min.[63] The mean serum T exceeded 288 ng/dl up to treatment days 147–246.

Treatment effects of T pellets waned after about 6 months, with patients

reporting declining libido and erectile function.[63]

Similar pharmacokinetic profiles were reported in an Australian study of

hypogonadal men receiving T pellets 600–1200 mg,[64] which showed that

absorption rate was not influenced by the sizes or number of pellets implanted.

In a review of 13 years of experience with T pellets, Handelsman reported

favorable clinical outcomes, with few AEs and a treatment continuation rate of

approximately 93%[62] ( Table 6 ). Other study findings are shown in Table

6.[63, 64, 65] In a number of studies, patients were so satisfied with T pellet

treatment that they elected to continue receiving this form of therapy rather

than return to their prior form of TRT.

The chief AEs with T pellets include pellet extrusion; minor bleeding, which is

typically insignificant and controlled by applying pressure to the surgical

wound; and infection, which is infrequent and may also result in pellet

extrusion. Some patients develop fibrosis (scarring, nodules) around

implantation sites, but this typically does not prevent further implantations.

Prospective randomized clinical trials have demonstrated that neither washing T

pellets in filtered sterile alcohol nor soaking them with an antibiotic

(gentamicin) prior to implantation significantly reduces the likelihood of

pellet extrusion.[65, 66] However, the use of povidone-iodine skin disinfectant

prior to the procedure does appear to lower pellet extrusion rates. The

likelihood of pellet extrusion may decline with increasing operator experience.

User and Prescriber Considerations

In an office procedure lasting approximately 15 min, T pellets are implanted

into the subdermal fat of the lower abdominal wall using a stainless-steel

wide-bore trocar under sterile conditions and a local anesthetic. Through a

small (0.5–1.0 cm) incision ≥5 cm from the midline at the umbilical level, a

7.5 F gauge 7-cm long trocar with an inner diameter of 5 mm is introduced and

the implants discharged into fan-like tracks 5–10 cm from the puncture site

using an obturator. In addition to the lower abdomen, implantation sites include

the deltoid, proximal thigh, or buttocks. Most patients return to work the day

of, or the day after, implantation but are advised to avoid bending or vigorous

physical activity

Regards,

Vergel

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