DOCSLIB.ORG

Pharmacology of HRT

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Pharmacology of HRT 9/29/2020 Pharmacology of HRT ~Victoria LB Grieve, PharmD 1 Introduction • Victoria Grieve, PharmD • Asst. Prof./Instructional Designer • Coordinate LGBTQIA+ Elective • PRIDE list member • GSWS Affiliated faculty 2 Disclosures I have no financial disclosures 3 1 9/29/2020 Objectives ● Describe the role of hormone therapy in transition care. ● Discuss nuances of different hormone transition regimens. ● Evaluate common misconceptions around HRT ● Understand HRT recommendations from guidelines ● Discuss the reasoning behind those guidelines 4 My Assumptions ● All familiar with nuances of gender/sex/expression ● Agree that HRT isn’t for everyone but is extremely necessary for those who need it ● Being trans is a normal aspect of humanity ● We are all here with the patient’s best interests in mind 5 Why Hormone Therapy ● Physical: ○ Help with bodily autonomy ○ Re-align physical with mental image of self ● Psychological: ○ Connect with expected emotions ○ Brain receptor theory 6 2 9/29/2020 Common Guidelines - Baseline for HRT ● WPATH (last updated 2011) ● UCSF (last updated 2016) ● Standard vs Informed Consent ● “Trans enough” vs “Informed enough” 7 Criteria for Care - Both ● Persistent, well-documented gender dysphoria* ● Capacity to make a fully informed decision and to consent for treatment* ● Age of majority* ● If significant medical or mental health concerns are present, they must be reasonably well controlled* 8 Limits to Therapy ● Genetics ● Age ○ Human Growth Hormone ● Wildcard 9 3 9/29/2020 Feminizing Therapy 10 Feminizing Therapy Effect Expected Onset Expected Max Effect Decreased Libido* 1 – 3 Months 1 – 2 Years Male Sexual Dysfunction* Highly Variable Highly Variable Body Fat Redistribution 3 – 6 Months 2 – 5 Years Decreased Muscle Mass 3 – 6 Months 1 – 2 Years Skin Changes 3 – 6 Months Highly Variable Breast Growth 3 – 6 Months 2 – 3 Years* Decreased Testicular Vol. 3 – 6 Months 2 – 3 Years Decreased Sperm Prod. Highly Variable Highly Variable Reduced Body/Facial Hair 6 – 12 Months > 3 Years Male Pattern Baldness* Loss stops 1 – 3 Months 1 – 2 Years 11 Feminizing Therapy - Risks ● Autoimmune disorders* ● Migraines* ● Gallstones* ● Many “non-clinically significant”* ● Venous Thromboembolism ● **Can always start with lower dose if concerned 12 4 9/29/2020 Feminizing Therapy - Risks ● Venous Thromboembolism ○ Increased effect of other risk factors ○ VTE Triad: ■ Exogenous estrogen (oral) ■ Smoking tobacco ■ Age > 35 13 Feminizing Therapy - Options ● Standard regimen: ○ Estradiol + Antiandrogen ● Options: ○ Type of Estradiol (PO, SL, TD, IM, SubQ?) ○ Type of AA (Spiro, Finasteride, Bicalutamide?) ○ Progestin (Micronized Progesterone) 14 Feminizing Therapy - Monitoring ● Guidelines suggest: ○ BUN/Cr/K+ ○ Lipids ○ A1C ○ Prolactin(?) ○ Estradiol (E2)/Total Estrogen (E1,E2,E3) ○ Testosterone 15 5 9/29/2020 Feminizing Therapy - Monitoring ● Guidelines suggest: ○ Estrogen level = “endogenous female range, luteal phase” ○ 100 - 200 pg/mL* ○ Estrogen cycle* 16 Feminizing Therapy - Tablets ● Estradiol Tablets ○ Start 2 - 4mg, Split dose if possible ○ Max recommended = 8mg/day ● PO vs SL ● Escalation dose? 17 Feminizing Therapy - Patches ● Estradiol Transdermal Patch ○ Start 0.1mg, switch twice a week (brand dependant) ○ Max recommended = 0.4mg ● Steady release, avoids first-pass ● Can be a burden with multiple patches ● Thought to be safest option, but rarely used 18 6 9/29/2020 Feminizing Therapy - Injection ● Estradiol Intramuscular Injection - 2 types ○ Valerate: Start 20mg, q2wk, Max = 40mg q2wk ○ Cypionate: Start 2mg, q2wk, Max = 5mg q2wk ● Can split into weekly doses* ● Faster breast growth? ● SubQ? 19 Feminizing Therapy - Antiandrogens ● Spironolactone - aldosterone antagonist ○ Start 50mg BID or 100mg QD ○ Max Recommended = 200mg BID or 400mg QD ● Potassium concern? ● Breast growth concern? ● Urination! 20 Feminizing Therapy - Antiandrogens ● Finasteride - 5-alpha-reductase inhibitor (DHT) ○ Start 1mg QD PO ○ Max Recommended = 5mg QD PO ● Possibly better for hair growth ● Dutasteride also possible to use 21 7 9/29/2020 Feminizing Therapy - Antiandrogens ● Bicalutamide? ○ Possible, expensive, rare ● Cyproterone acetate? ○ Not legal in US, used in other countries as first line ● Needed at all? ○ Depends on person, possibly only at beginning 22 Feminizing Therapy - Progestins ● Micronized Progesterone ○ Start 100mg PO QHS ○ Max Recommended = 200mg PO QHS* ● Controversial use (breast, hips, skin, hair, mood) ● Will make drowsy, help sleep ● Medroxyprogesterone? ● Don’t stick it in your butt! 23 Masculinizing Therapy 24 8 9/29/2020 Masculinizing Therapy Effect Expected Onset Expected Max Effect Skin Changes 1 – 6 Months 1 – 2 Years Cessation of Menses 2 – 6 Months n/a Body/Facial Hair Growth 3 – 6 Months 3 – 5 Years Body Fat Redistribution 3 – 6 Months 2 – 5 Years Clitoral Enlargement 3 – 6 Months 1 – 2 Years Vaginal Atrophy 3 – 6 Months 1 – 2 Years Deepened Voice 3 – 12 Months 1 – 2 Years Increased Muscle Mass 6 – 12 Months 2 – 5 Years Scalp Hair Loss >12 Months Highly Variable 25 Masculinizing Therapy - Risks ● Acne/Balding* ● Hyperlipidemia* ● Destabilization of psychiatric disorders** ● Polycythemia 26 Masculinizing Therapy - Risks ● Polycythemia ○ Thrombogenic erythrocytosis ○ Reason T is a controlled substance ○ Unlikely to be clinically significant ● Pregnancy is absolute contraindication 27 9 9/29/2020 Masculinizing Therapy - Options ● Standard Therapy: ○ Testosterone ● Options: ○ Type of Testosterone (IM, TD, Implant, PO?) ○ Other supportive medications (E mods, finasteride, depo- provera) 28 Masculinizing Therapy - Monitoring ● Guidelines suggest: ○ Lipids ○ A1C ○ Estradiol (E2) ○ Testosterone ○ SHBG/Albumin (complex cases only) 29 Masculinizing Therapy - Monitoring ● Guidelines suggest: ○ Testosterone level = “endogenous male range, average” ○ 350 - 700 ng/dL* 30 10 9/29/2020 Masculinizing Therapy - Injection ● Testosterone Intramuscular Injection -2 types ○ Enanthate: Start 50mg, Qwk, Max = 100mg Qwk ○ Cypionate: Start 50mg, Qwk, Max = 100mg Qwk ● Sesame vs Cottonseed oil ● IM or SubQ 31 Masculinizing Therapy - Transdermal ● Testosterone Transdermal Patches ○ Start 4mg QPM, Max = 8mg QPM ● Testosterone Transdermal Cream/Gel ○ Start 50mg QAM, Max = 100mg QAM ● Risk of accidental exposure 32 Masculinizing Therapy - Other T-options ● Testosterone Pellets ○ 75mg pellets, implanted subQ every 3-6 months ● Testosterone Undecanoate Injection ○ 750mg Q4wks, eventually Q10wks ● Testosterone Undecanoate Capsule? ○ Recent release, could be used in future 33 11 9/29/2020 Masculinizing Therapy - Other Medications ● Depo-Provera, 150mg Q3months ○ Can be used to halt stubborn menses ● Finasteride, 1mg QD ○ Can be used to halt balding, but will conflict with T=>DHT ● Aromatase Inhibitors ○ Prevents estrogen production from androgens 34 HRT Summary ● Guidelines are fine, with some blind spots ○ Not recently updated ○ Dubious evidence to be built from ○ Uphold transmedicalist attitude ● Lack of strong evidence allows for misinformation ● Trans men are men (in all ways) ● Trans women are women (in all ways) 35 Questions? Email: [email protected] [email protected] 36 12 9/29/2020 References 1. Deutsch, M. B. (Ed.). (2016). Guidelines for the primary and gender-affirming care of transgender and gender nonbinary people. University of California, San Francisco. 2. World Professional Association for Transgender Health. (2011). Standards of care for the health of transsexual, transgender, and gender nonconforming people. World Professional Association for Transgender Health. 3. Grant, J. M., Mottet, L. A., Tanis, J., Herman, J. L., Harrison, J., & Keisling, M. (2010). National transgender discrimination survey report on health and health care. Washington, DC: National Center for Transgender Equality and the National Gay and Lesbian Task Force. 4. Haas, A. P., Rodgers, P. L., & Herman, J. L. (2014). Suicide attempts among transgender and gender non- conforming adults. work, 50, 59. 5. Meerwijk, E. L., & Sevelius, J. M. (2017). Transgender population size in the United States: a meta- regression of population-based probability samples. American journal of public health, 107(2), e1-e8. 37 References 6. National Center for Transgender Equality. 2015 U.S. Transgender Survey. http://www.ustranssurvey.org. Published December 2016. Accessed September 4, 2018. 7. Legal, L., & New York City Bar Association. (rev 2016). Creating equal access to quality health care for transgender patients: Transgender-affirming hospital policies. 8. Rosendale, N., Goldman, S., Ortiz, G. M., & Haber, L. A. (2018). Acute Clinical Care for Transgender Patients: A Review. JAMA Internal Medicine. 9. Coleman, E., Bockting, W., Botzer, M., Cohen-Kettenis, P., DeCuypere, G., Feldman, J., ... & Monstrey, S. (2012). Standards of care for the health of transsexual, transgender, and gender-nonconforming people, version 7. International journal of transgenderism, 13(4), 165-232. 38 13.
Load more

Recommended publications
  • Gender-Affirming Hormone Therapy
    GENDER-AFFIRMING HORMONE THERAPY Julie Thompson, PA-C Medical Director of Trans Health, Fenway Health March 2020 fenwayhealth.org GOALS AND OBJECTIVES 1. Review process of initiating hormone therapy through the informed consent model 2. Provide an overview of masculinizing and feminizing hormone therapy 3. Review realistic expectations and benefits of hormone therapy vs their associated risks 4. Discuss recommendations for monitoring fenwayhealth.org PROTOCOLS AND STANDARDS OF CARE fenwayhealth.org WPATH STANDARDS OF CARE, 2011 The criteria for hormone therapy are as follows: 1. Well-documented, persistent (at least 6mo) gender dysphoria 2. Capacity to make a fully informed decision and to consent for treatment 3. Age of majority in a given country 4. If significant medical or mental health concerns are present, they must be reasonably well controlled fenwayhealth.org INFORMED CONSENT MODEL ▪ Requires healthcare provider to ▪ Effectively communicate benefits, risks and alternatives of treatment to patient ▪ Assess that the patient is able to understand and consent to the treatment ▪ Informed consent model does not preclude mental health care! ▪ Recognizes that prescribing decision ultimately rests with clinical judgment of provider working together with the patient ▪ Recognizes patient autonomy and empowers self-agency ▪ Decreases barriers to medically necessary care fenwayhealth.org INITIAL VISITS ▪ Review history of gender experience and patient’s goals ▪ Document prior hormone use ▪ Assess appropriateness for gender affirming medical
    [Show full text]
  • Gender-Affirming Hormone Therapy
    GENDER-AFFIRMING HORMONE THERAPY Julie Thompson, PA-C Medical Director of Trans Health Fenway Health November 2019 fenwayhealth.org GOALS AND OBJECTIVES 1.Review process of initiating hormone therapy through the informed consent model 2.Provide an overview of masculinizing and feminizing hormone therapy 3.Review realistic expectations and benefits of hormone therapy vs their associated risks 4.Discuss recommendations for monitoring fenwayhealth.org PROTOCOLS AND STANDARDS OF CARE fenwayhealth.org WPATH STANDARDS OF CARE, 2011 The criteria for hormone therapy are as follows: 1. Well-documented, persistent (at least 6mo) gender dysphoria 2. Capacity to make a fully informed decision and to consent for treatment 3. Age of majority in a given country 4. If significant medical or mental health concerns are present, they must be reasonably well controlled fenwayhealth.org INFORMED CONSENT MODEL ▪ Requires healthcare provider to ▪ Effectively communicate benefits, risks and alternatives of treatment to patient ▪ Assess that the patient is able to understand and consent to the treatment ▪ Informed consent model does not preclude mental health care! ▪ Recognizes that prescribing decision ultimately rests with clinical judgment of provider working together with the patient ▪ Recognizes patient autonomy and empowers self-agency ▪ Decreases barriers to medically necessary care fenwayhealth.org INITIAL VISITS ▪ Review history of gender experience ▪ Document prior hormone use ▪ Review patient goals ▪ Assess appropriateness for gender affirming medical
    [Show full text]
  • FDA Briefing Document NDA 206089 Testosterone Undecanoate
    FDA Briefing Document NDA 206089 Testosterone Undecanoate (proposed trade name Jatenzo) For replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Bone, Reproductive, and Urologic Drugs Advisory Committee (BRUDAC) Meeting January 9, 2018 Division of Bone, Reproductive, and Urologic Products Office of New Drugs Division of Clinical Pharmacology 3 Office of Clinical Pharmacology Center for Drug Evaluation and Research 1 DISCLAIMER STATEMENT The attached package contains background information prepared by the Food and Drug Administration (FDA) for the panel members of the advisory committee. The FDA background package often contains assessments and/or conclusions and recommendations written by individual FDA reviewers. Such conclusions and recommendations do not necessarily represent the final position of the individual reviewers, nor do they necessarily represent the final position of the Review Division or Office. We have brought a new drug application (NDA 206089) for testosterone undecanoate oral capsules (proposed trade name, JATENZO), intended for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone sponsored by Clarus Therapeutics, Inc, to this Advisory Committee in order to gain the Committee’s insights and opinions. The background package may not include all issues relevant to the final regulatory recommendation and instead is intended to focus on issues identified by the Agency for discussion by the advisory committee. The FDA will not issue a final determination on the issues at hand until input from the advisory committee process has been considered and all reviews have been finalized. The final determination may be affected by issues not discussed at the advisory committee meeting.
    [Show full text]
  • Steroids and Other Appearance and Performance Enhancing Drugs (Apeds) Research Report
    Research Report Revised Febrero 2018 Steroids and Other Appearance and Performance Enhancing Drugs (APEDs) Research Report Table of Contents Steroids and Other Appearance and Performance Enhancing Drugs (APEDs) Research Report Introduction What are the different types of APEDs? What is the history of anabolic steroid use? Who uses anabolic steroids? Why are anabolic steroids misused? How are anabolic steroids used? What are the side effects of anabolic steroid misuse? How does anabolic steroid misuse affect behavior? What are the risks of anabolic steroid use in teens? How do anabolic steroids work in the brain? Are anabolic steroids addictive? How are anabolic steroids tested in athletes? What can be done to prevent steroid misuse? What treatments are effective for anabolic steroid misuse? Where can I get further information about steroids? References Page 1 Steroids and Other Appearance and Performance Enhancing Drugs (APEDs) Research Report Esta publicación está disponible para su uso y puede ser reproducida, en su totalidad, sin pedir autorización al NIDA. Se agradece la citación de la fuente, de la siguiente manera: Fuente: Instituto Nacional sobre el Abuso de Drogas; Institutos Nacionales de la Salud; Departamento de Salud y Servicios Humanos de los Estados Unidos. Introduction Appearance and performance enhancing drugs (APEDs) are most often used by males to improve appearance by building muscle mass or to enhance athletic performance. Although they may directly and indirectly have effects on a user’s mood, they do not produce a euphoric high, which makes APEDs distinct from other drugs such as cocaine, heroin, and marijuana. However, users may develop a substance use disorder, defined as continued use despite adverse consequences.
    [Show full text]
  • MEDICATION GUIDE JATENZO® (Juh-TEN-Zoh) (Testosterone
    MEDICATION GUIDE JATENZO® (juh-TEN-zoh) (testosterone undecanoate) capsules, for oral use CIII What is the most important information I should know about JATENZO? JATENZO can cause serious side effects, including: JATENZO can increase your blood pressure, which can increase your risk of having a heart attack or stroke and can increase your risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke. If your blood pressure increases while on JATENZO, blood pressure medicines may need to be started. If you are taking blood pressure medicines, new blood pressure medicines may need to be added or your current blood pressure medicines may need to be changed to control your blood pressure. If your blood pressure cannot be controlled, JATENZO may need to be stopped. Your healthcare provider will monitor your blood pressure while you are being treated with JATENZO. What is JATENZO? JATENZO is a prescription medicine that contains testosterone. JATENZO is used to treat adult men who have low or no testosterone due to certain medical conditions. It is not known if JATENZO is safe or effective in children younger than 18 years old. Improper use of JATENZO may affect bone growth in children. JATENZO is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your JATENZO in a safe place to protect it. Never give your JATENZO to anyone else, even if they have the same symptoms you have.
    [Show full text]
  • Study on Sperm Suppression Using Norethisterone Enanthate and Testosterone Undecanoate
    Study on sperm suppression using Norethisterone enanthate and testosterone undecanoate Objectives Overall goal: and The study was designed to address the following primary objectives: Background 1. The rate of suppression of spermatogenesis induced by a regimen of NET-EN and TU administered every 8 weeks for up to 4 injection visits; and 2. The level of contraceptive protection provided by the continued administration of NET-EN and TU every 8 weeks for an efficacy period of up to 56 weeks. Background: The study was designed to evaluate whether the combination of a progestin, norethisterone enantate (NET-EN), and an androgen, testosterone undecanoate (TU), represents a safe and effective method of male fertility regulation. The study had 3 phases. The suppression phase was to initiate a status of decreased sperm count and activity to a level which would be considered as contraceptive. When this was reached it was sustained with subsequent injections in the efficacy phase, which would end after 56 weeks, or if a pregnancy occurs. After these, the participant was then placed in the recovery phase, and was observed until normal sperm counts and activity returns to normal. 487 participants were screened for eligibility, of which 167 were excluded. The remaining 320 were enrolled into the study, into the suppression phase. A total of 274 completed the suppression phase. Of these 8 discontinued before transitioning to the Efficacy phase, and were moved to recovery phase. A total of 266 transitioned to the efficacy phase, among which 111 completed 56 weeks follow up or until a pregnancy occurred. The remaining 155 were discontinued, either because of the stopping of the study by the sponsor (96), death (1, unrelated to the study), or for other reasons (58).
    [Show full text]
  • NON-CLINICAL REVIEW(S) DEPARTMENT of HEALTH & HUMAN SERVICES Food and Drug Administration
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 206089Orig1s000 NON-CLINICAL REVIEW(S) DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration PHARMACOLOGY/TOXICOLOGY MEMORANDUM CDER Stamp Date: September 27, 2018 NDA: 206089 Sponsor: Clarus Therapeutics, Inc. Drug: Testosterone undecanoate (JATENZO) Replacement therapy in adult males for conditions associated Indication: with a deficiency or absence of endogenous testosterone due to primary or hypogonadotropic hypogonadism Subject: Final Labeling Review Reviewer: Yangmee Shin, PhD Background: Clarus Therapeutics resubmitted NDA 206089 under a 505(b)(2) regulatory pathway following a 2nd Complete Response (CR) letter issued on March 22, 2018. NDA 206089 was first submitted on January 3, 2014 as a 505(b)(2) application. To support the nonclinical requirements of NDA via a 505(b)(2) pathway, the sponsor submitted published literature along with the findings of a 3-month oral toxicology study of Clarus’ oral testosterone undecanoate (TU) formulation in dogs. The sponsor also provided literature references to address ADME of TU by the oral route. The 3-month oral toxicology study in male dogs and relevant published literature were provided to support the use of borage oil as a novel excipient. The sponsor also supplied published literature regarding the fertility, pregnancy, and carcinogenicity of testosterone (T). Pharmacology and Toxicology recommended approval of the initial submission of NDA 206089 during the first cycle review. In the 1st resubmission to NDA 206089 on June 22, 2017, Clarus refiled the NDA as a 505(b)(1) application and provided nonclinical studies of oral TU including a 9-month oral toxicology study in male dogs, a battery of genotoxicity tests, a 6-month carcinogenicity study in Tg·rasH2 male mice, and a fertility study in male rats, upon agreement with the Division on November 19, 2015.
    [Show full text]
  • DATA SHEET 1. REANDRON® 1000 (1000 Mg/4 Ml Solution for Injection)
    DATA SHEET 1. REANDRON® 1000 (1000 mg/4 mL solution for injection) Reandron 1000, 1000 mg/ 4 mL solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ampoule/vial contains 1000 mg testosterone undecanoate (equivalent to 631.5 mg testosterone) in a 4 mL solution for injection (250 mg testosterone undecanoate/mL). Each mL solution for injection contains 250 mg testosterone undecanoate corresponding to 157.9 mg testosterone. For a full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Reandron 1000 is a clear, colourless to yellowish-brown oily solution for injection. Testosterone undecanoate is a white or off-white crystalline substance. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Testosterone replacement in primary and secondary male hypogonadism. 4.2 Dose and method of administration 4.2.1 Dose Reandron 1000 (1 ampoule/vial equivalent to 1000 mg testosterone undecanoate) is injected every 10 to 14 weeks for testosterone replacement, where testosterone deficiency has been confirmed by clinical features and biochemical tests. Injections with this frequency are capable of maintaining sufficient testosterone levels and do not lead to accumulation. 4.2.1.1 Start of Treatment Serum testosterone levels should be measured before start of treatment and during initiation of treatment. Depending on serum testosterone levels and clinical symptoms, the first injection interval may be reduced to a minimum of 6 weeks as compared to the recommended range of 10 to 14 weeks for maintenance. With this loading dose, sufficient steady-state testosterone levels may be achieved more rapidly. 4.2.1.2 Individualisation of Treatment The injection interval should remain within the recommended range of 10 to 14 weeks.
    [Show full text]
  • AVEED® (Testosterone Undecanoate)
    MEDICATION GUIDE AVEED® (Uh-Veed) (testosterone undecanoate) injection Read this Medication Guide before you receive AVEED and before each injection. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment. What is the most important information I should know about AVEED? AVEED may cause serious side effects, including: • A serious lung problem. AVEED can cause a serious lung problem called a pulmonary oil microembolism (POME) reaction. POME is caused by tiny droplets of oil that have traveled to the lungs. Symptoms of a POME reaction may include: o cough or urge to cough o difficulty breathing o sweating o tightening of your throat o chest pain o dizziness o fainting • Serious allergic reactions (anaphylaxis). AVEED can cause a serious allergic reaction right after receiving the injection. Some of these allergic reactions may be life threatening. These reactions can happen after you receive your first dose of AVEED or may happen after receiving more than 1 dose. You may need emergency treatment in a hospital, especially if these symptoms get worse over the 24 hours after your AVEED injection. These side effects may happen during or right after each injection. To be sure that you are not having one of these reactions: • You need to stay in the doctor’s office, clinic, or hospital for 30 minutes after having your AVEED injection so that your doctor can watch you for symptoms of POME or a serious allergic reaction. • You can only get AVEED at your doctor’s office, clinic, or hospital.
    [Show full text]
  • Testosterone Undecanoate)
    POLICIES AND PROCEDURE MANUAL Policy: MBP 116.0 Section: Medical Benefit Pharmaceutical Policy Subject: Aveed (testosterone undecanoate) I. Policy: Aveed (testosterone undecanoate) II. Purpose/Objective: To provide a policy of coverage regarding Aveed (testosterone undecanoate) III. Responsibility: A. Medical Directors B. Medical Management C. Pharmacy Department IV. Required Definitions 1. Attachment – a supporting document that is developed and maintained by the policy writer or department requiring/authoring the policy. 2. Exhibit – a supporting document developed and maintained in a department other than 3. the department requiring/authoring the policy. 4. Devised – the date the policy was implemented. 5. Revised – the date of every revision to the policy, including typographical and grammatical changes. 6. Reviewed – the date documenting the annual review if the policy has no revisions necessary. V. Additional Definitions Medical Necessity or Medically Necessary means Covered Services rendered by a Health Care Provider that the Plan determines are: a. appropriate for the symptoms and diagnosis or treatment of the Member's condition, illness, disease or injury; b. provided for the diagnosis and the direct care and treatment of the Member's condition, illness disease or injury; c. in accordance with current standards good medical treatment practiced by the general medical community; d. not primarily for the convenience of the Member, or the Member's Health Care Provider; and e. the most appropriate source or level of service that can
    [Show full text]
  • Determination of Testosterone Esters in Serum by Liquid Chromatography – Tandem Mass Spectrometry (LC-MS-MS)
    Department of Physics, Chemistry and Biology Final Thesis Determination of testosterone esters in serum by liquid chromatography – tandem mass spectrometry (LC-MS-MS) Erica Törnvall Final Thesis performed at National Board of Forensic Medicine 2010-06-03 LITH-IFM-EX--10/2263--SE Department of Physics, Chemistry and Biology Linköping University 581 83 Linköping, Sweden 1 Department of Physics, Chemistry and Biology Determination of testosterone esters in serum by liquid chromatography – tandem mass spectrometry (LC-MS-MS) Erica Törnvall Final Thesis performed at National Board of Forensic Medicine 2010-06-03 Supervisors Yvonne Lood Martin Josefsson Examiner Roger Sävenhed 2 Avdelning, institution Datum Division, Department Date 2010-06-03 Chemistry Department of Physics, Chemistry and Biology Linköping University Språk Rapporttyp ISBN Language Report category Svenska/Swedish Licentiatavhandling ISRN: LITH-IFM-EX--10/2263--SE Engelska/English Examensarbete _________________________________________________________________ C-uppsats D-uppsats Serietitel och serienummer ISSN ________________ Övrig rapport Title of series, numbering ______________________________ _____________ URL för elektronisk version Titel Title Determination of testosterone esters in serum by liquid chromatography – tandem mass spectrometry (LC-MS-MS) Författare Author Erica Törnvall Sammanfattning Abstract Anabolic androgenic steroids are testosterone and its derivates. Testosterone is the most important naturally existing sex hormone for men and is used for its anabolic effects providing increased muscle mass. Testosterone is taken orally or by intramuscular injection in its ester form and are available illegally in different forms of esters. Anabolic androgenic steroids are today analyzed only in urine. To differentiate between the human natural testosterone and exogenous supply the quote natural testosterone and epitestosterone is used.
    [Show full text]
  • Effects of Administering Testosterone Undecanoate in Rats
    Brazilian Journal of Pharmaceutical Sciences vol. 46, n. 1, jan./mar., 2010 Article Effects of administering testosterone undecanoate in rats subjected to physical exercise: effects on the estrous cycle, motor behavior and morphology of the liver and kidney Moisés Tolentino Bento-Silva1,3,*, Maria do Carmo de Carvalho e Martins2, Francisco Leonardo Torres-Leal1,3, Talvany Luiz Barros3, Ingrid Lara do Nascimento Ferreira de Carvalho2, Hugo Aparecido Carvalho Filho2, Fernanda Regina de Castro Almeida3 1Department of Physical Education, Federal University of Piauí, 2Department of Physiology and Biophysics, Federal University of Piauí, 3Medicinal Plants Research Center, Federal University of Piauí The aim of the work was evaluate the effects of testosterone undecanoate (TU) treatment combined with moderate physical training on: the estrous cycle, body weight (BW), motor behavior (MB), and the morphohistology of the reproductive system, the liver and kidney in rats. Female Wistar rats (180 g - 250 g) were divided as follows: sedentary + TU (S + TU), trained + TU (T + TU), sedentary + vehicle (S + V), trained + vehicle (T + V). The rats swam 50 min/Day, strapped with a 5% BW load, for 4 weeks. During this training, (BW) was monitored daily as well as the estrous cycle (EC) by vaginal smear. The TU (15 mg/kg s.c) was administered 3 times/week for 4 weeks. At the end of the study, data on MB, BW and morphohistopathological changes in viscera were compiled. The (T + TU) group had on average, a higher (BW) in the fourth week compared to the first week, and (BW) higher than (S + V) and (S + TU) groups.
    [Show full text]