What kind of test is androgel

Muscle strength was assessed at baseline and then at six monthly intervals with the one-repetitive maximum technique in bench press and seated leg press exercises.

The one-repetitive maximum technique assesses the maximal force-generating capacity of the muscles used to perform the test. Stillwater, MN. Urine calcium Ca and creatinine Cr were estimated by an autoanalyzer. All hormone and biochemical data generated at Harbor-UCLA Medical Center were verified and audited by comparison with original laboratory data before transmitting to the data collection center of the sponsor.

Body composition total body mass, lean body mass, fat mass, and percent fat and BMD at the hip and spine were measured by dual energy x-ray absorptiometry with or A series Hologic, Waltham, MA at baseline, 6, 18, and 30 months after the start of T replacement therapy. BMD of spine was calculated as the sum of measured bone mineral content at L1-L4 and divided by the total area of L1-L4 and that of left hip, calculated by the bone mineral content of the proximal femur divided by the area of the region measured.

The scans were centrally analyzed and processed at Synarc Maynard, MA. The between-center CV using the spine phantom was 0. The subjects were asked to complete the questionnaire daily for 7 consecutive days before each clinic visit 2 , 5 , 6.

At each clinic visit when the diaries were collected, the study coordinator reviewed the questionnaires for completeness and clarified all missing data. The questionnaire covered three different domains: 1 sexual desire, enjoyment, and performance; 2 sexual activity score; and 3 mood.

Sexual desire and sexual enjoyment with and without partners were rated on a 7-point Likert-type scale from 0 to 7, with 0 indicating none and 7 indicating very high.

The latter two items were left blank if the subject did not have an erection allowing the determination of the percent of men without erections. The weekly value for these items was the simple average of the score for the 7 d.

Sexual activity was assessed using a checklist format. The subjects recorded whether they had sexual daydreams, anticipation of sex, flirting by themselves or others , sexual interactions with partner, erection, masturbation, intercourse, orgasm, and ejaculation on each of the 7 d.

The value was recorded as 0 none or 1 any for analysis. The weekly value for the sexual activity items was the sum of the number of any responses for the week. The sexual activity score was then calculated as the average of the weekly values for all of the items.

The mood parameters were assessed on the 7-point Likert scale. The weekly value of each of these items was the average of the 7 d. Positive mood was the average of the four positive mood parameters alert, full of pep, friendly, well.

Negative mood was the average of the five negative mood parameters angry, irritable, sad or blue, tired, and nervous. When subjects developed skin irritation, pretreatment with corticosteroid cream was advised. The maximum score for IPSS is The study protocol was approved by the institutional review board of each of the study centers. Written consent was obtained from each subject.

Descriptive statistics for each of the hormone levels were calculated. Before analysis, each variable was examined for its distributional characteristics and, if necessary, transformed to meet the requirements of a normal distribution. There were no significant differences among the study sites on any of the parameters; therefore, the data have been pooled for all the centers. All parameters during AndroGel treatment were compared with the values at 0 baseline and 6 months corresponding to the start and end of the initial 6-month randomized study.

Comparisons of change in serum T and free T concentrations between dosage groups at each treatment time were done using ANOVA after log transformations of the values, followed by Student-Newman-Keuls test for pairwise comparisons. Analysis of the changes was done over the 30 months total time in treatment using repeated-measures ANOVA with all subjects included as a single group.

If the overall ANOVA was significant, then values for each treatment time were compared with baseline. The model was repeated within diagnosis groups to compare suppression of FSH and LH in subjects with primary hypogonadism with those with normal or low serum gonadotropins. The analyses were also repeated within age groups to compare changes in efficacy parameters between older and younger subjects.

The P values reported for the repeated-measures analyses are the overall P values for the time effect. SAS version 6. The characteristics of the subjects who participated in the long-term study are shown in Table 1.

The mean age of the subjects was The age, height, weight, diagnosis, and racial distribution were similar in the 62, 22, and 39 subjects who were receiving 5, 7. Of these, The number of evaluable subjects at each time point up to 36 months is shown in Fig. Data were not shown for the 35 subjects who were evaluated at 42 months. Subjects who did not change medication dose from month 6 until leaving the study.

Serum T and free T concentrations in patients receiving AndroGel 5 closed circles , 7. The number of subjects in the study at each time point is shown at the bottom of the graph. In this and subsequent figures, the dotted lines when shown represent the adult male reference range.

Serum T and free T concentrations in the three dose groups are shown in Fig. Note that after the initial 6 months of the randomized trial, dose adjustments were allowed at each visit, depending on symptoms of the subjects. At 6 months, which is the beginning of the long-term study, mean serum T levels were at Thereafter with dose adjustment for the subjects, serum T levels were not different among the three groups.

Serum free T followed the same pattern as serum T and also showed no significant differences among the dose groups after 12 months. The percent free T showed no significant change during the study. Mean serum T and free T levels throughout the study were not different among the groups of subjects who were younger than or older than 60 yr. Because the mean serum T and free T differences among the dose groups were small and became not significant with dose adjustments by each physician to maintain serum T concentrations within the adult male reference change, all other serum hormone and efficacy data are presented for all subjects as a group.

Significant differences among the dose groups are discussed with each parameter. Note that in the upper and middle panels , the closed circles represent all the subjects, whereas in the lower panel showing the gonadotropin levels, the closed squares represent the subjects with primary hypogonadism and the open squares represent those with secondary hypogonadism, aging-related hypogonadism, and normogonadotropic hypogonadism.

Serum SHBG showed no significant change with treatment and remained within the adult male reference range. This suppression of LH and FSH was maintained throughout the treatment period without further significant changes after 6 months Fig. The suppression was more pronounced in the g group than the lower doses. The proportion of subjects with erections increased from a baseline of There was overall improvement in psychosexual function in men over 60 yr, but the changes were smaller, compared with those younger than 60 yr of age e.

Changes in sexual function and mood parameters as assessed by a self-report questionnaire during AndroGel treatment. Average total body mass increased by 1. The change in lean body mass was 1. The differences in the lean body mass between the dose groups and those over and under age 60 yr were not significant. The changes in body composition parameters were not related to the change in serum T concentrations during replacement therapy.

Changes in body composition A and muscle strength B during treatment with AndroGel. Muscle strength testing of the upper and lower extremities by the chest and leg press increased, but this did not reach statistical significance over time Fig. The mean chest press increased by 1. There were no sustained differences among the different dose groups or between subjects who were younger or older than 60 yr. Serum SALP showed the same pattern, increasing from a baseline of Serum osteocalcin levels increased transiently during the initial few months of treatment baseline 4.

At month 12 serum osteocalcin was significantly elevated, again compared with values at 6 months 5. Serum and urine bone turnover markers in hypogonadal men during AndroGel treatment. NTX, N -telopeptide. The increase in the BMD was more marked in the spine than the hip.

Spine BMD increased by 0. There were no significant differences in the improvement in BMD among the three dose groups or between the younger and older age groups. The increases were not different between the groups at months 30 and The T gel dose was reduced or temporarily discontinued in these patients. Serum total and low-density lipoprotein LDL cholesterol levels did not change significantly throughout the T gel treatment period.

The increase was not clinically relevant. The mean increase varied from 0. Serum total bilirubin also showed a small 0. There were no significant changes in serum liver enzymes or other clinical chemistry parameters.

None of the individual scores showed any clinically meaningful changes. Most of these patients had enlarged prostate at baseline assessment. Mean urine flow was not increased in the subjects as a group. Except in one subject, there were no lower urinary tract obstructive symptoms in any subject that resulted in a serious adverse event or discontinuation from the study.

Except for those subjects reported in Table 2 , these subjects continued on T gel treatment. Mean serum PSA concentrations are shown in Fig 7. The baseline PSA level was 0. Mean serum PSA was 1. There was no difference in serum PSA levels among the three T gel dose groups. Two subjects , had transient elevations of PSA without any symptoms, and on repeat analysis on a subsequent sample, the serum PSA returned to within the normal range. These were ascribed to laboratory errors by the investigators.

In addition, there were seven subjects whose serum PSA rose above the predetermined critical value of 5. 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. Products or treatments described on this site are available in the U. I am a licensed Healthcare Professional and wish to proceed to the Healthcare Professionals Only section of this site.

You are leaving the AndroGel. 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. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility.

Conversely, the presence of this link does not imply the linked site's endorsement of AndroGel. When you use this card, you are confirming that you have not submitted and will not submit a claim for this prescription for reimbursement under any federal, state, or government-funded healthcare program, such as Medicare including Part D , Medicare Advantage, Medicaid, Medigap, Veterans Affairs, the Department of Defense, or TRICARE. Keep it away from children.

When it is time to throw away the pump, safely throw away used AndroGel 1. Be careful to prevent accidental exposure of children or pets. Keep AndroGel 1. Products or treatments described on this site are available in the U.

I am a licensed Healthcare Professional and wish to proceed to the Healthcare Professionals Only section of this site. You are leaving the AndroGel. 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.

You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility. Conversely, the presence of this link does not imply the linked site's endorsement of AndroGel. When you use this card, you are confirming that you have not submitted and will not submit a claim for this prescription for reimbursement under any federal, state, or government-funded healthcare program, such as Medicare including Part D , Medicare Advantage, Medicaid, Medigap, Veterans Affairs, the Department of Defense, or TRICARE.

General questions about AndroGel 1. Apply to shoulders and upper arms only. Avoid showering, swimming, or bathing for at least 2 hours after applying AndroGel 1. Are AndroGel 1. What is AndroGel 1. Why did my doctor prescribe AndroGel 1. Does AndroGel 1. Signs and symptoms of a blood clot in your leg can include leg pain, swelling, or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain Possible increased risk of heart attack or stroke In large doses, AndroGel 1.

This may cause serious problems for people who have heart, kidney, or liver disease Enlarged or painful breasts Having problems breathing while you sleep sleep apnea The most common side effects of AndroGel 1. Who should not use AndroGel 1. Do not use AndroGel 1. Talk to your doctor before taking this medicine if you have any of the above conditions. Stop taking the medication and seek immediate medical attention if any of the following occur:.

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication. Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood tests: Your doctor may recommend that you have regular blood tests while using this medication to check whether the medication is working and whether you are having certain side effects. Also, the use of testosterone may interfere with a number of laboratory tests. Tell all health professionals administering these tests that you are using this medication.

Breast cancer: Long-term use of testosterone may increase the risk of developing breast cancer. Talk to your doctor if you have concerns. Diabetes: This medication may affect blood sugar levels. If you have diabetes, your doctor may ask you to monitor your blood sugar carefully while using this medication.

Heart disease: Testosterone can cause increased blood pressure and may cause fluid to build up in the body. Both conditions can increase the risk of certain types of heart disease. In addition, androgens have been linked to increased risk of heart disease, including congestive heart failure, increased or irregular heart rate, heart attack and stroke. If you have heart disease or risk factors for developing heart disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney or liver disease: If you have kidney or liver disease, your doctor should monitor your condition closely while you are using this medication. Report any swelling in the feet and lower legs to a doctor immediately. Prostate problems: Medications such as testosterone may increase the speed at which prostate cancer or benign prostatic hypertrophy BPH, or enlarged prostate progresses.

If you have a history of prostate cancer or BPH, or you are at risk of developing prostate cancer, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Sleep disorders: Treatment with testosterone may cause sleep apnea interruption of breathing during sleep and high blood pressure for some people, especially those with risk factors such as being overweight or having a chronic lung disease.

Soy allergy: Some testosterone products are synthesized from soy. If you are allergic to soy, check with your doctor before using this medication.

Sperm counts: This medication may reduce sperm counts if high doses are used, or if it is used for a prolonged period.