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Discussion in 'Men's Health Forum' started by frankwhardy, Sep 30, 2005.
My dog ate my homework.
yeah yeah. All good. You can believe me or not, your choice. I understand the skepticism though. I'll continue doing what I'm doing, you do you. I've got the results to prove that it's working for me as well as guidance from a handful of very well known members. The way I see it, my pics don't lie.
To each their own bud.
I know I'm not running replacement doses...but
i've been doing test e 500mg for a few cycles, twice weekly, and armidex EOD.
no infections, no adverese effects. I've learned that holding up the fat and pushing the needle 180 angle into it and slowly injecting while lightly pulling out the needle works great, min to no burning or lump. I've also done tren ace and tren enth this way
Sorry for bump but did you experience any difference compared to IM cycle? Blood work?
nope. All blood has come back the same, once it's under the skin it will be absorbed.
Antares Pharma Announces Completion of the QuickShot testosterone Clinical Program
Antares Pharma, Inc. (ATRS) today announced safety results from the dose-blinded, multiple-dose, concentration-controlled, 26-week phase 3 study of QuickShot® Testosterone (QST) administered subcutaneously once each week to adult males with hypogonadism.
The study, QST-15-005, included a screening phase, a titration phase and a treatment phase for evaluation of safety and tolerability, including laboratory assessments, adverse events and injection site assessments.
The safety population, defined as patients who received at least one dose of study drug, was comprised of 133 patients.
The most common adverse reactions (incidence ≥5%) in this study were increased hematocrit, upper respiratory tract infection and injection site ecchymosis.
There were four patients with treatment emergent serious adverse events (SAE’s), which included one patient with transient visual impairment determined not to be drug related, one patient with appendicitis that was not drug related and one patient with deep vein thrombosis (DVT). The investigator attributed DVT as possibly drug related, which is consistent with known testosterone class SAE’s.
The fourth patient had multiple hospitalizations related to septic arthritis and coronary artery disease, with a complicated clinical course post-angioplasty. These multiple reported events from the fourth patient were deemed not to be drug related.
There have been no reported adverse events consistent with urticaria (hives), POME or anaphylaxis.
The safety data collected also included an assessment of pain. Of the 965 injections assessed, pain was reported one time. In that instance, the pain reported was classified as mild.
Antares Pharma (ATRS) Announces Submission Of New Drug Application For Quickshot testosterone.
Antares Pharma Announces Submission Of New Drug Application For Quickshot Testosterone
EWING, N.J., Dec. 21, 2016 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (ATRS) today announced that it had submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for QuickShot® Testosterone (QST), a drug-device combination product for the delivery of testosterone enanthate using a subcutaneous auto injector. QST is intended to treat adult men with low testosterone associated with a condition known as hypogonadism.
Would doing subQ cause DHT levels to raise higher opposed to intermuscular due to subq going into fat?
Antares Pharma (ATRS) Announces FDA Acceptance of NDA for Quickshot testosterone
Antares Pharma Announces FDA Acceptance of New Drug Application for Quickshot® Testosterone
Antares Pharma, Inc. (NASDAQ: ATRS) today announced that the New Drug Application (NDA) for QuickShot® Testosterone (QST), a drug-device combination product for the delivery of testosterone enanthate using a subcutaneous auto injector, has been accepted for standard review by the U.S Food and Drug Administration (FDA). QST was developed to treat adult men with low testosterone associated with a diagnosed condition known as hypogonadism.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of October 20, 2017, ten months from the official NDA submission. The PDUFA date is the target date for the FDA to complete its review of the NDA.
Spratt DI, Stewart I, Savage C, et al. Subcutaneous Injection of testosterone is an Effective and Preferred Alternative to Intramuscular Injection: Demonstration in Female-to-Male Transgender Patients. J Clin Endocrinol Metab. 2017. https://academic.oup.com/jcem/article-abstract/doi/10.1210/jc.2017-00359/3098651/Subcutaneous-Injection-of-Testosterone-is-an?redirectedFrom=fulltext
Context: Testosterone is commonly administered intramuscularly (IM) to treat hypogonadal males and female-to-male transgender (FTM) patients. However, these injections can involve significant discomfort and may require arrangements for administration by others.
Objective: We assessed whether T could be administered effectively and safely by the subcutaneously (SC) as an alternative to IM injections.
Design: Retrospective cohort study.
Setting: Outpatient Reproductive Endocrinology Clinic at an academic medical center.
Patients: Sixty-three FTM transgender patients aged >18 years electing to receive SC T therapy for gender transition were included. Fifty-three patients were premenopausal.
Intervention: Patients were administered T cypionate or enanthate weekly at an initial dose of 50mg. Dose was adjusted if needed to achieve serum total T levels within the normal male range.
Main outcome measurements: Serum concentrations of free and total T and total estradiol (E2), masculinization and surveillance for reactions at injection sites.
Results: Serum T levels within the normal male range were achieved in all 63 patients with doses of 50-150mg (median 75/80 mg). Therapy was effective across a wide range of body mass index (BMI) (19.0-49.9 kg/m2). Minor and transient local reactions were reported in 9/63 patients. Among 53 premenopausal patients, 51 achieved amenorrhea and 35 achieved serum E2 concentrations <50 pg/mL. Twenty-two patients were originally receiving IM and switched to SC therapy. All 22 had a mild (n=2) or marked (n=20) preference for SC injections; none preferred IM injections.
Conclusions: Our observations indicate that SC T injections are an effective, safe and well-accepted alternative to IM T injections.
FDA Rejects Xyosted for Hypogonadism
FDA Rejects Xyosted for Hypogonadism
The US Food and Drug Administration (FDA) has rejected the QuickShot testosterone (XYOSTED) for the treatment of low testosterone levels associated with hypogonadism in adult males, announced Antares Pharma.
Antares Pharma received a response letter from the FDA regarding the New Drug Application (NDA) indicating that the FDA cannot approve XYOSTED in its present form.
The letter identified 2 deficiencies related to clinical data based on findings in studies QST-13-003 and QST-15-005.
The FDA expressed concern that XYOSTED could cause a meaningful increase in blood pressure, as well as questioned the occurrence of depression and suicidality. No Chemistry, Manufacturing and Controls (CMC), device or efficacy issues were noted in the letter.
On Oct. 12, Antares Pharma announced it received notice from the FDA which identified unnamed deficiencies preventing the drug from moving forward in the labeling and postmarketing requirements process. In the letter, the FDA did not specify the deficiencies.
The drug-device combination product delivers testosterone enanthate using a subcutaneous auto injector for adult males with low testosterone associated with hypogonadism. XYOSTED is being designed an at home, weekly, self-administered testosterone replacement option.
XYOSTED is designed to allow the rapid subcutaneous self-administration of highly viscous drugs like testosterone and biologics using a high spring pressure through a fine gauge needle. Phase 3 data showed that testosterone delivered provided rapid, steady and reliable efficacy by restoring testosterone to pre-defined physiologic levels.
Antares Pharma (ATRS) Reports Written Request for Type A Meeting Submitted to FDA in Response to CRL received Regarding NDA for XYOSTED
Antares Pharma, Inc. (NASDAQ: ATRS) today announced that a written request for a Type A meeting, along with a comprehensive briefing document, have been submitted to the U.S. Food and Drug Administration (FDA), in response to the Complete Response Letter (CRL) received by Antares regarding the New Drug Application (NDA) for XYOSTED™, the Company’s investigational new drug for the treatment of testosterone deficiency (hypogonadism).
A Type A meeting is a formal meeting that is requested by the sponsor within three months after an FDA regulatory action for purposes of discussing post-CRL activities. The meeting should be scheduled to occur within 30 days of FDA receipt of a written meeting request. Once a meeting date has been set, Antares intends to present the contents of the briefing document to the FDA with the primary goal of determining a path forward for re-submission of the XYOSTED™ NDA.
Daily Subcutaneous testosterone for Management of Testosterone Deficiency
Testosterone deficiency (TD) is a public health concern, a predictor of metabolic syndrome, and is associated with an increased all-cause and cardiovascular mortality. Testosterone deficiency in men is treated by a variety of methods including injectable testosterone compounds, patches, gels, pellets, and oral preparations. The use of testosterone alone has been linked to various adverse effects including, infertility, testicular atrophy, erythropoiesis, and gynecomastia.
To determine the effectiveness of therapy using the Daily Subcutaneous Testosterone (DST) method in combination with human chorionic gonadotropin (hcg) and an aromatase inhibitor (anastrozole), a retrospective analysis was conducted of men diagnosed and treated for TD. Changes in testosterone, estradiol, sex hormone binding globulin (SHBG), luteinizing hormone (LH), follicle stimulating hormone (FSH), dihydrotestosterone (DHT), dehydroepiandrosterone sulfate (DHEA-S), prostate-specific antigen (PSA), pregnenolone, and hemoglobin were determined.
There was a significant increase in total testosterone, free serum testosterone, and direct free testosterone in the testosterone treated patients. There was a significant increase in total and free testosterone levels with the DST method combined with hCG and anastrozole, suggesting that DST therapy is a viable option to restore testosterone levels in men.
Yazdani N, Matthews Branch S. Daily subcutaneous testosterone for management of testosterone deficiency. Frontiers in bioscience (Elite edition) 2018;10:334-43. http://www.bioscience.org/2018/v10e/af/825/list.htm
I’ve bedn doing all shots of all gear sub q for over a year now and have noted no difference, except that I never get any pip anymore.
McFarland J, Craig W, Clarke NJ, Spratt DI. Serum testosterone Concentrations Remain Stable Between Injections in Patients Receiving Subcutaneous Testosterone. Journal of the Endocrine Society 2017;1:1095-103. https://academic.oup.com/jes/article/1/8/1095/3988127
Purpose: Intramuscular (IM) testosterone is the most common modality for testosterone therapy of both male hypogonadism and female-to-male (FTM) gender transition. However, IM injections can be painful and often are not self-administered by the patient. The objective of this study was to further characterize subcutaneous (SC) administration of testosterone as an effective and safe alternative to IM injections by evaluating the pharmacodynamics of serum total and free testosterone concentrations between weekly testosterone injections.
Methods: Eleven FTM transgender patients already receiving weekly SC testosterone cypionate with documented therapeutic levels prior to enrollment had free and total serum testosterone levels measured at eight different time points during a 1-week dosing interval.
Results: Mean levels of total and free testosterone were stable and remained well within the normal range between injections. Overall mean +/- standard deviation levels for the seven samples taken between injections were 627 +/- 206 ng/dL (range, 205 to 1410) for total testosterone and 146 +/- 51 pg/mL (range, 38 to 348) for free testosterone. No adverse effects were encountered.
Conclusions: The results of this study support use of SC testosterone to achieve therapeutic and stable serum testosterone levels for the purpose of gender transition. It is anticipated that these results can be extended to hypogonadal men. This route may be preferred over IM testosterone because it is relatively painless and easy to self-inject thus allowing for the convenience and economy of patient self-administration.
[OA] Pharmacokinetics, Safety, and Patient Acceptability of Subcutaneous Versus Intramuscular testosterone Injection
PURPOSE: Results of a study comparing testosterone exposure and tolerability with subcutaneous versus i.m. administration are presented.
METHODS: In a prospective, open-label, crossover study, adult participants already on stable i.m. testosterone gender-affirming therapy self-injected testosterone cypionate or enanthate i.m. for 3 weeks followed by subcutaneous injections for 8 weeks. Trough serum testosterone concentrations were determined weekly, and serial total serum testosterone (TST) concentrations were determined on postinjection days 1, 3, and 5 of weeks 3 and 11. Hemoglobin and alanine transaminase (ALT) levels were measured at week 3 (the first visit), with repeat measurements at week 11 (the final visit). The dose-normalized area under the time-concentration curve (AUC) was calculated during weeks 3 and 11.
RESULTS: Fourteen transgender males (mean age, 30 +/- 10 years) participated in the study. The mean hemoglobin values at the first and final visits were 160 +/- 9 and 153 +/- 9 g/L, respectively (p > 0.05); the mean ALT values were 18 +/- 6 and 21 +/- 10 IU/L (p > 0.05).
Total testosterone exposure was comparable with subcutaneous versus i.m. injection (mean AUC, 1.7 +/- 0.6 nmol.days/L/mg versus 1.9 +/- 0.6 nmol.days/L/mg; p > 0.05). Information collected via weekly questionnaires indicated that the subcutaneous route was more tolerable, with lower self-reported scores for preinjection anxiety, pain during injection, and postinjection pain.
CONCLUSION: The subcutaneous route for the injection of testosterone was well tolerated and appeared to be as effective as i.m. injection in delivering equivalent TST levels, although there was wide intrapatient and interpatient variability.
Wilson DM, Kiang TKL, Ensom MHH. Pharmacokinetics, safety, and patient acceptability of subcutaneous versus intramuscular testosterone injection for gender-affirming therapy: A pilot study. American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists 2018. Pharmacokinetics, safety, and patient acceptability of subcutaneous versus intramuscular testosterone injection for gender-affirming therapy: A pilot study
what the best base for sub q? my oil based trt is not happy sub q. got huge golf ball sized knots that slowly dissipated
I have been kicking around the idea of test suspension subq. Thoughts?
only one way to find out. give it whirl let me know lol.
For what its worth I did a sub q one time on accident trying to see if I could use shorter needles than I was an i gt a lump on my ass the size of a tennis ball it sucked to sit for over a week