What kind of testosterone is androgel
For AndroGel 1. Axiron is a clear solution in a pump bottle that gives 30 milligrams mg per pump. It comes with an application cap that you use to apply the solution.
You can pump the solution into the cap. You should apply one dose of Axiron each day to your armpit area. The skin in your armpit area is relatively thin. The medication can quickly absorb through your skin and then into your bloodstream.
Touching the solution directly as you apply it can cause too much of the medication to be absorbed into your bloodstream. It can also make it easier for you to transfer the drug to someone else. You should rinse and dry the cap after each application and also wash your hands with soap and water. You will get the best results if you apply the Axiron at the same time each day, right after showering.
If you use deodorant, apply it before you apply Axiron. AndroGel is a clear gel. The pump dispenses a single dose of The gel packets come in one or two doses in the following strengths:. You apply one dose each day to your shoulders, upper arms, or abdomen. Apply AndroGel with the palm of your hand and massage it in. You can accidentally transfer either drug to someone else if you touch them after applying it.
These drugs are anabolic steroids. They can cause harmful physical and psychological effects. Women who come in contact with testosterone treatments may develop acne and male characteristics, such as increased body and facial hair.
Children who are routinely exposed to Axiron or AndroGel may show aggressive behavior or experience early puberty or swelling of the genitals. Both AndroGel and Axiron can cause the same side effects. Some side effects are mild and will go away on their own after your body gets used to the medicine. Trouble urinating can be a sign of an enlarged prostate or prostate cancer. Testosterone therapy may increase your prostate-specific antigen PSA levels and cause prostatitis, which is inflammation of your prostate.
Study results reported in Clinical Endocrinology suggest that topical medications such as Axiron and AndroGel are safe and effective for increasing testosterone levels and improving the quality of life in men who have low testosterone levels. However, the U. AbbVie is not responsible for the content of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience, and the inclusion of any link does not imply the endorsement of the linked site by AbbVie.
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Conversely, the presence of this link does not imply the linked site's endorsement of AndroGel. One subject had an elevated PSA to 6. Subject was discontinued from the study, referred to a urologist, diagnosed to have prostatitis, and treated with antibiotics. Subject had elevated serum PSA during treatment, and prostate biopsy showed adenocarcinoma.
Subject had normal serum PSA at screening which rose to 6. Subject had normal PSA on screening, which rose to 5. At 24 months repeat biopsy showed prostate cancer.
Subject was treated with 10 g T gel for over 36 months when a transurethral resection was performed for lower urinary tract symptoms. In addition to the prostate disease described above, there were two serious adverse events possibly related to treatment. One was the subject who had transurethral resection as described above and another with normogonadotropin hypogonadism who had deep vein thrombosis deemed to be possibly related to T replacement.
Application site skin reaction occurred in 12 of subjects five, three, and four subjects were receiving 5, 7. Only one subject discontinued from the study after 12 months of 5 g T treatment because of worsening of minimal erythema and punctate rash. Gynecomastia was observed only in eight more subjects during treatment 4. Breast enlargement was rated as mild in five and moderate in three subjects; all resolved without treatment. Acne was noted in 12 subjects 7. None of these subjects was discontinued because of acne.
Overall compliance was , The compliance was relatively good, considering the long duration of the study. Because the subjects were not preselected for these tests, the data presented were unbiased results that would be representative of the study population. Moreover, the data from the subjects demonstrated sustained improvements that were consistent within each subject and each parameter assessed.
Because this was a long-term, open-label, follow-up study, subject attrition, allowance for dose adjustment, incomplete assessment of measures in all subjects, and noncompliance in some subjects were unavoidable. Although the present study departs from the idealized follow-up study, we believe that the data presented from this 3-yr followup study are relevant to the clinical practice of androgen replacement in hypogonadal men demonstrating the maintenance of the responses to T treatment.
In our prior reports, serum T and free T concentrations were proportional to the dose of T gel 5 or 10 g gel per day administered in hypogonadal men 1. Recently other T gels have been studied 6 — 9 , but none had reported long-term efficacy and safety data for up to 42 months of T gel exposure. In this report except for the first 12 months, serum T and free T concentrations were not different among the three dose groups during the T gel replacement period.
The loss of dose proportionality could be ascribed to the dose adjustment performed by the investigators when the subjects had symptoms or when serum T levels were outside of the adult male reference range. The total number of subjects participating in the study was reduced with time, especially at 36 months of drug exposure.
The mean serum T and free T concentrations in all dose groups were at the mid reference range from 12 months of treatment onward. Despite the fact that DHT has been reported in vitro to have higher relative binding activity to the androgen receptor and in vivo in experimental animals more androgenic activity 10 , it remains unclear whether circulating DHT has higher in vivo androgenic activity on multiple target organs in men.
Whereas it is clear that intraprostatic conversion of T to DHT is critical for androgenic effects on prostate tissue, most of the DHT in the prostate is derived from conversion of T to DHT within the prostate cells. It is also not known what the relative contribution of equal amounts circulating T and DHT would be on the concentration of intraprostatic DHT Serum E 2 levels increased progressively with time with AndroGel treatment until 24 months and thereafter plateaued.
The mean serum E 2 remained at the upper limit of the male reference range. This gradual increase in E 2 was not reported in our prior shorter-term study 1. The cause of this increase in E 2 is not known and could be due to the increased aromatization of T to E 2 in the skin or adipose tissues 12 , Serum SHBG levels were not changed in this study, similar to our prior findings 1 , suggesting that steady and physiological concentrations achieved by AndroGel treatment does not cause decreases in SHBG production by the liver.
As anticipated, serum LH and FSH concentrations were suppressed to low levels, and this suppression was sustained throughout the T gel treatment period. Sexual function improved rapidly after T replacement in hypogonadal men, and this improvement was sustained throughout the study without significant differences among the different dose groups.
The improvements assessed by a validated self-reporting questionnaire 6 affected all aspects of sexual function including motivation, performance, and activity. This improvement in sexual function has been reported in prior reports 3 , 5 , 7 , 8 , 14 , Sexual activity improvement after T replacement in hypogonadal men is not dose dependent, and as soon as serum T is restored to the lower adult male concentrations, sexual function is returned to normal As a group, mood changes improved early after institution of replacement, and this improvement was maintained in the study period.
Overall the improvement in psychosexual function was greater in the younger men. As previously reported by other investigators and by our earlier studies on shorter duration of T treatment, enhancement of positive mood was more prominent than the decrease in negative mood parameters 3 , 5 , Because there was no placebo group, some of the initial effect of T gel could have been due to a placebo effect, but sustained behavioral changes argued against this. With the improvement in sexual function and mood, it is likely that the quality of life in these hypogonadal men would be improved.
This was not specifically assessed in this study, and instruments for hypogonadal men that may be more sensitive to the effects of T treatment may have to be developed.
Increases in lean body mass average of about 3 kg occurred in the hypogonadal men as early as 3 months and were sustained with continuous T replacement both in younger and older men. This increase was associated with a very small increase in total weight and loss of fat mass. The decrease in fat mass and percent body fat failed to reach statistical significance in older men in this study possibly because of the small number of older subjects.
Such changes in body composition with T replacement had been shown previously in young and older men 3 , 5 , 7 , 15 , 16 , 18 — The increase in lean mass is likely due to muscle fiber hypertrophy that is increased with T treatment It should be noted that in this long-term T replacement study, the changes in body composition plateaued after 12 months treatment.
The changes in fat mass and lean mass have been shown to be dependent on the serum T achieved after exogenous T replacement Overall, the changes in muscle and fat mass were not different in the different dose groups, most likely because of the dose adjustment that occurred in some subjects to maintain the serum T concentrations within the adult male range.
Increases in muscle strength associated with increases in lean mass after T replacement have been reported by us and others 3 , 14 , In this longer-term study, the mean strength in both upper and lower extremities increased as a group, but because of the marked variability, this failed to reach statistical significance over time.
This finding is similar to that reported by Snyder et al. Assessment of bone markers showed that serum PTH and SALP showed a steady increase over the first 12 months and then remained at the same level during the treatment period. Such increases in serum PTH have been reported by us 3 , 5 , 18 and could be related to the early decreases in serum calcium 3.
The other markers of bone formation, osteocalcin and procollagen, followed the same pattern. The early rise and subsequent decrease after T replacement therapy of serum osteocalcin have been previously reported 3 , 5 , In this study we showed that both serum osteocalcin and procollagen rose further at 6 months and then plateaued at a higher level at 12 months of T treatment than at baseline.
Urinary bone resorption markers decreased to reach a trough in the first 6 months of treatment and then became very variable. Similar decreases in urine bone resorption markers within 6 and 12 months of T replacement followed by no further decreases in hypogonadal men were reported by Katznelson et al. Taken together in our long-term study of AndroGel replacement of hypogonadal men, the bone markers indicated that there was an early phase in which there was decreased bone resorption and increased bone formation and a later phase in which there is no apparent further decrease in bone resorption but a suggestion of a second phase of continued increase in bone formation.
BMD increased with T replacement therapy in hypogonadal younger men 5 , 18 , 23 , 27 but not in some older men 25 , In our study BMD continued to increase by 0. BMD in the spine increased both in older and younger men. In the subjects treated by Snyder et al. Most of the subjects in our study had been previously on T replacement, which could have improved baseline BMD status, and therefore the full benefit of testosterone was underappreciated.
The absolute change in BMD in response to T treatment in hypogonadal young and older men is highest when the initial serum T and BMD are the lowest 3 , The few case reports of estrogen receptor mutations and aromatase deficiency in males were all associated with severe osteoporosis 28 — In addition, there is strong evidence that estrogen is also important in maintaining BMD in adult men 31 , Epidemiological studies also demonstrate that BMD is related to serum E 2 and bioavailable E 2 concentrations and experimental studies in men showed that estrogens are important in maintaining bone mass Thus, the current hypothesis is that the presence of adequate estrogen levels is required for achievement and maintenance of peak BMD in men.
The concentration of serum E 2 or the level of estrogen activity in the target tissues required to maintain BMD is not known, although recent work would suggest that there indeed may be a critical level of bioavailable E 2 that is required to maintain bone resorption in check 32 , Whereas it is apparent that some estrogenic action is required for normal BMD, it is probable that T has positive effects on BMD through both estrogen and androgen receptor-related mechanisms.
In our study serum E 2 rose with continued T replacement to reach the upper limit of the normal range. As in prior reports on AndroGel 3 , skin irritability is minimal and caused discontinuation in only one subject. The anticipated appearance of acne occurred in a very small number of subjects. The hemoglobin and hematocrit levels increased as anticipated with androgen replacement, but the increase reached the maximum level at 6—12 months with no further increases with continued T gel replacement.
The number of subjects with high hemoglobin or hematocrit that required discontinuation was similar to other reports 23 , 34 , There were small and clinically nonsignificant increases in creatinine and bilirubin in the subjects without any significant changes in liver enzymes or electrolytes. Mean I-PPS scores were not increased in subjects as a group.
One subject had transurethral resection of the prostate for lower urinary tract symptoms. Of the subjects who had elevated PSA during the study, three had confirmed prostate cancer on biopsy. All three subjects were over 63 yr old at enrollment in the study. In prior T replacement treatment of smaller numbers of hypogonadal men, no cancer of the prostate was reported 18 , The incidence of prostate cancer in three of 1.
However, if only men over 60 yr enrolled in this study were considered, the incidence would be higher: three of 39 7. Based on the data from the Surveillance, Epidemiology, and End Result Program of the National Cancer Institute, the anticipated incidence of prostate cancer in the population of men between the ages of 65 and 74 yr is between and cases per , men [National Cancer Institute, Surveillance, Epidemiology, and End Result SEER Program , www.
However, with the close monitoring of PSA in this study, the heightened awareness of the investigators, and the rate of referral to a urologist for prostate biopsy could cause the incidence to be increased. One could postulate, however, that during intervention studies such as the present study, the increased surveillance as shown by other studies 36 would result in higher prostate biopsy and higher cancer detection rate The cancers might therefore be detected earlier, leading to a higher cure rate.
It is not clear whether androgen replacement in hypogonadal men will result in growth or development of a prostate cancer. In the recent evidence-based report by the Institute of Medicine, the issue of T replacement in androgen deficiency associated with aging in men remains controversial, and more controlled studies are required In each subject with adult-onset hypogonadism associated with aging, the benefits must be balanced and carefully assessed against the potential risks for the patient.
In older subjects, it is prudent to monitor serum PSA and conduct digital rectal examinations very early after the initiation of treatment 1—3 months and then follow up the subjects periodically as recommended by practice guidelines We conclude that AndroGel replacement in hypogonadal men led to restoration of serum T and free T into the adult male range.
The improvements in sexual function and mood were sustained with long-term treatment. The decrease in fat mass and increase in lean mass were persistent with T replacement. Serum bone markers showed changes suggestive of an increase in bone formation and BMD increase both in the hip and spine. The safety parameters were comparable with other delivery systems.
However, the benefits of androgen replacement must be weighed against potential risks. As with all androgen replacement, continuous vigilance is required for the monitoring of hemoglobin and hematocrit and serum PSA for values that are above the critical range that intervention may be necessary.
In addition to the ease of administration and the lack of skin irritation, we conclude that AndroGel is also safe and effective when used in the long-term treatment of hypogonadal men. Berger, M. Dula, M. Kaufman, M. Scheinman, M. Hutman, M. Schwartz, M. Steidle, M. Susset, M. Wells, M. The authors also thank Barbara Steiner, R. Diabetes and Glandular Disease Clinic, P. The authors thank A.
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