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												Hormonal Treatment Strategies Tailored to Non-Binary Transgender Individuals
Journal of Clinical Medicine Review Hormonal Treatment Strategies Tailored to Non-Binary Transgender Individuals Carlotta Cocchetti 1, Jiska Ristori 1, Alessia Romani 1, Mario Maggi 2 and Alessandra Daphne Fisher 1,* 1 Andrology, Women’s Endocrinology and Gender Incongruence Unit, Florence University Hospital, 50139 Florence, Italy; [email protected] (C.C); jiska.ristori@unifi.it (J.R.); [email protected] (A.R.) 2 Department of Experimental, Clinical and Biomedical Sciences, Careggi University Hospital, 50139 Florence, Italy; [email protected]fi.it * Correspondence: fi[email protected] Received: 16 April 2020; Accepted: 18 May 2020; Published: 26 May 2020 Abstract: Introduction: To date no standardized hormonal treatment protocols for non-binary transgender individuals have been described in the literature and there is a lack of data regarding their efficacy and safety. Objectives: To suggest possible treatment strategies for non-binary transgender individuals with non-standardized requests and to emphasize the importance of a personalized clinical approach. Methods: A narrative review of pertinent literature on gender-affirming hormonal treatment in transgender persons was performed using PubMed. Results: New hormonal treatment regimens outside those reported in current guidelines should be considered for non-binary transgender individuals, in order to improve psychological well-being and quality of life. In the present review we suggested the use of hormonal and non-hormonal compounds, which—based on their mechanism of action—could be used in these cases depending on clients’ requests. Conclusion: Requests for an individualized hormonal treatment in non-binary transgender individuals represent a future challenge for professionals managing transgender health care. For each case, clinicians should balance the benefits and risks of a personalized non-standardized treatment, actively involving the person in decisions regarding hormonal treatment. - 
												
												Uses of Bremelanotide in Therapy for Female Sexual
(19) TZZ __T (11) EP 2 916 856 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 9/00 (2006.01) A61K 38/12 (2006.01) 19.09.2018 Bulletin 2018/38 A61P 15/00 (2006.01) C07K 7/64 (2006.01) (21) Application number: 13851014.4 (86) International application number: PCT/US2013/068386 (22) Date of filing: 05.11.2013 (87) International publication number: WO 2014/071339 (08.05.2014 Gazette 2014/19) (54) USES OF BREMELANOTIDE IN THERAPY FOR FEMALE SEXUAL DYSFUNCTION VERWENDUNG VON BREMELANOTID IN DER THERAPIE VON WEIBLICHER SEXUELLER DYSFUNKTION UTILISATIONS DE BRÉMÉLANOTIDE DANS UNE THÉRAPIE DE DYSFONCTIONNEMENT SEXUEL FÉMININ (84) Designated Contracting States: • "Palatin Technologies Presents Positive Results AL AT BE BG CH CY CZ DE DK EE ES FI FR GB for Phase 2B Bremelanotide Female Sexual GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO Dysfunction Trial", PRNewswire , 8 November PL PT RO RS SE SI SK SM TR 2012 (2012-11-08), XP002757483, Retrieved from the Internet: (30) Priority: 05.11.2012 US 201261722511 P URL:http://www.palatin.com/investors/press 28.02.2013 US 201361770535 P -releases/ [retrieved on 2016-05-09] • ROSEN R C ET AL: "Evaluation of the safety, (43) Date of publication of application: pharmacokineticsand pharmacodynamic effects 16.09.2015 Bulletin 2015/38 of subcutaneously administered PT-141, a melanocortin receptor agonist, in healthy male (73) Proprietor: Palatin Technologies, Inc. subjects and in patients with an inadequate Cranbury NJ 08512 (US) response to Viagra(R)", INTERNATIONAL JOURNAL OF IMPOTENCE RESEARCH, (72) Inventors: STOCKTON, BASINGSTOKE, GB, vol. - 
												
												Research Publications by DISTINCTIONS Any Scientist of Pakistan in Last 10 Year and SERVICES  Secretary General, the Chemical Society of Pakistan
CV and List of Publications PROF. DR. MUHAMMAD IQBAL CHOUDHARY (Hilal-e-Imtiaz, Sitara-e-Imtiaz, Tamgha-ei-Imtiaz) International Center for Chemical and Biological Sciences (H. E. J. Research Institute of Chemistry, Dr. Panjwani Center for Molecular Medicine and Drug Research) University of Karachi, Karachi-75270 Pakistan Tel: (92-21) 34824924, 34824925 Fax: 34819018, 34819019 E-mail: [email protected] Web Page: www.iccs.edu Biodata and List of Publications Pag No. 2 MUHAMMAD IQBAL CHOUDHARY (Hilal-e-Imtiaz, Sitara-e-Imtiaz, Tamgha-e-Imtiaz) D-131, Phase II, D. O. H. S., Malir Cant., Karachi-75270, Pakistan Ph.: 92-21-4901110 MAILING INTERNATIONAL CENTER FOR CHEMICAL AND BIOLOGICAL SCIENCES ADDRESS (H. E. J. Research Institute of Chemistry Dr. Panjwani Center for Molecular Medicine and Drug Research) University of Karachi Karachi-74270, Pakistan Tel: (92-21) 34824924-5 Fax: (92-21) 34819018-9 Email: [email protected] Web: www.iccs.edu DATE OF BIRTH September 11, 1959 (Karachi, Pakistan) EDUCATION Doctor of Science (D.Sc.) (University of Karachi ) 2005 Ph.D. (Organic Chemistry) 1987 H. E. J. Research Institute of Chemistry University of Karachi, Karachi-75270, Pakistan Thesis Title: "The Isolation and Structural Studies on Some Medicinal Plants of Pakistan, Buxus papillosa, Catharanthus roseus, and Cissampelos pareira." M.Sc. (Organic Chemistry) 1983 University of Karachi, Karachi-75270, Pakistan B.Sc. (Chemistry, Biochemistry, Botany) 1980 University of Karachi, Karachi-75270, Pakistan AWARDS & Declared as the top most scientist (Number 1) among 1,650 HONORS scientists of Pakistan in all disciplines / fields of science and technology (year 2012) by the Pakistan Council for Science and Technology (Ministry of Science and Technology), Pakistan. - 
												
												Progestogens and Venous Thromboembolism Among Postmenopausal Women Using Hormone Therapy. Marianne Canonico, Geneviève Plu-Bureau, Pierre-Yves Scarabin
Progestogens and venous thromboembolism among postmenopausal women using hormone therapy. Marianne Canonico, Geneviève Plu-Bureau, Pierre-Yves Scarabin To cite this version: Marianne Canonico, Geneviève Plu-Bureau, Pierre-Yves Scarabin. Progestogens and venous throm- boembolism among postmenopausal women using hormone therapy.. Maturitas, Elsevier, 2011, 70 (4), pp.354-60. 10.1016/j.maturitas.2011.10.002. inserm-01148705 HAL Id: inserm-01148705 https://www.hal.inserm.fr/inserm-01148705 Submitted on 5 May 2015 HAL is a multi-disciplinary open access L’archive ouverte pluridisciplinaire HAL, est archive for the deposit and dissemination of sci- destinée au dépôt et à la diffusion de documents entific research documents, whether they are pub- scientifiques de niveau recherche, publiés ou non, lished or not. The documents may come from émanant des établissements d’enseignement et de teaching and research institutions in France or recherche français ou étrangers, des laboratoires abroad, or from public or private research centers. publics ou privés. Progestogens and VTE Finale version Progestogens and venous thromboembolism among postmenopausal women using hormone therapy Marianne Canonico1,2, Geneviève Plu-Bureau1,3 and Pierre-Yves Scarabin1,2 1 Centre for Research in Epidemiology and Population Health, U1018, Hormones and Cardiovascular Disease 2 University Paris-Sud, UMR-S 1018, Villejuif, France 3 University Paris Descartes and Hôtel-Dieu Hospital, Paris, France Adresse: 16 av. Paul Vaillant Couturier 94807 Villejuif Cedex Tel: +33 1 45 59 51 66 Fax: +33 1 45 59 51 70 Corresponding author: Marianne Canonico ([email protected]) 1/21 Progestogens and VTE Finale version Abstract Hormone therapy (HT) is the most effective treatment for correcting menopausal symptoms after menopause. - 
												
												Steroid Abuse by School Age Children
epartment .D of .S Ju U s t ic U.S. Department of Justice e . n o i Drug Enforcement Administration t a r t is D in Office of Diversion Control r m ug d E t A nforcemen www.dea.gov www.DEAdiversion.usdoj.gov epartment .D of .S Ju U s t ic e . n o i t a r t is D in r m ug d E t A nforcemen Office of Diversion Control www.dea.gov STEROID ABUSE BY SCHOOL AGE CHILDREN nce viewed as a problem strictly associated with body builders, Ofitness “buffs,” and professional athletes, abuse of anabolic steroids by school age children has significantly increased over the past decade. The National Institute on Drug Abuse (NIDA) estimates that more than a half million 8th and 10th grade students are now using these dangerous drugs, and increasing numbers of high school seniors do not believe steroids are risky. Students are acquiring and taking anabolic steroids without any knowledge of the dangers associated with steroid abuse. The short- term adverse physical effects of anabolic steroid abuse are fairly well known. However, the long-term adverse physical effects of anabolic steroid abuse have not been studied, and as such, are not known. In addition, this type of abuse may result in harmful side-effects as well as serious injury and death. The abuser in most cases is unaware of these hidden dangers. Presented as a public service by: This guide will help you understand why steroids are being misused, Drug Enforcement Administration and how you can provide counseling and implement procedures to Office of Diversion Control educate our youth about the dangers of these drugs. - 
												
												Role of Androgens, Progestins and Tibolone in the Treatment of Menopausal Symptoms: a Review of the Clinical Evidence
REVIEW Role of androgens, progestins and tibolone in the treatment of menopausal symptoms: a review of the clinical evidence Maria Garefalakis Abstract: Estrogen-containing hormone therapy (HT) is the most widely prescribed and well- Martha Hickey established treatment for menopausal symptoms. High quality evidence confi rms that estrogen effectively treats hot fl ushes, night sweats and vaginal dryness. Progestins are combined with School of Women’s and Infants’ Health The University of Western Australia, estrogen to prevent endometrial hyperplasia and are sometimes used alone for hot fl ushes, King Edward Memorial Hospital, but are less effective than estrogen for this purpose. Data are confl icting regarding the role of Subiaco, Western Australia, Australia androgens for improving libido and well-being. The synthetic steroid tibolone is widely used in Europe and Australasia and effectively treats hot fl ushes and vaginal dryness. Tibolone may improve libido more effectively than estrogen containing HT in some women. We summarize the data from studies addressing the effi cacy, benefi ts, and risks of androgens, progestins and tibolone in the treatment of menopausal symptoms. Keywords: androgens, testosterone, progestins, tibolone, menopause, therapeutic Introduction Therapeutic estrogens include conjugated equine estrogens, synthetically derived piperazine estrone sulphate, estriol, dienoestrol, micronized estradiol and estradiol valerate. Estradiol may also be given transdermally as a patch or gel, as a slow release percutaneous implant, and more recently as an intranasal spray. Intravaginal estrogens include topical estradiol in the form of a ring or pessary, estriol in pessary or cream form, dienoestrol and conjugated estrogens in the form of creams. In some countries there is increasing prescribing of a combination of estradiol, estrone, and estriol as buccal lozenges or ‘troches’, which are formulated by private compounding pharmacists. - 
												
												Preclinical Effects of Melanocortins in Male Sexual Dysfunction
International Journal of Impotence Research (2008) 20, S11–S16 & 2008 Nature Publishing Group All rights reserved 0955-9930/08 $30.00 www.nature.com/ijir Preclinical effects of melanocortins in male sexual dysfunction AM Shadiack1 and S Althof2 1Locus Pharmaceuticals, Blue Bell, PA, USA and 2The Center for Marital and Sexual Health of South Florida, West Palm Beach, FL, USA The neurobiology of sexual behavior involves the interrelationships between sex steroids and neurotransmitters that result in both central nervous system (CNS) effects and effects in the genitalia. Tools such as positron emission tomography (PET) and functional magnetic resonance imaging (fMRI) scanning can help determine what areas of the brain are activated under sexual stimulation. Our understanding of the role of various neurotransmitters, neurosteroids and other CNS-acting compounds is improving. The role of CNS-acting compounds such as dopamine agonists in the treatment of male sexual dysfunction is under active investigation. Melanocortins have CNS and peripheral roles in a wide variety of bodily functions. The melanocortin agonist bremelanotide appears to act in the CNS to promote erections in preclinical models, and may also stimulate behaviors that facilitate sexual activity beyond their erectogenic effects. International Journal of Impotence Research (2008) 20, S11–S16; doi:10.1038/ijir.2008.17 Keywords: erectile dysfunction; neuroanatomy; neurophysiology; CNS-acting agents; melanocortins; bremelanotide Introduction Neuroanatomy of male sexual response The neurobiology of sexual behavior involves the Sex and the brain interrelationships between sex steroids and neuro- Sexual arousal can now be studied with such transmitters that result in both central nervous sophisticated tools as PET (positron emission system (CNS) effects and effects in the genitalia. - 
												
												A Pharmaceutical Product for Hormone Replacement Therapy Comprising Tibolone Or a Derivative Thereof and Estradiol Or a Derivative Thereof
Europäisches Patentamt *EP001522306A1* (19) European Patent Office Office européen des brevets (11) EP 1 522 306 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) Int Cl.7: A61K 31/567, A61K 31/565, 13.04.2005 Bulletin 2005/15 A61P 15/12 (21) Application number: 03103726.0 (22) Date of filing: 08.10.2003 (84) Designated Contracting States: • Perez, Francisco AT BE BG CH CY CZ DE DK EE ES FI FR GB GR 08970 Sant Joan Despi (Barcelona) (ES) HU IE IT LI LU MC NL PT RO SE SI SK TR • Banado M., Carlos Designated Extension States: 28033 Madrid (ES) AL LT LV MK (74) Representative: Markvardsen, Peter et al (71) Applicant: Liconsa, Liberacion Controlada de Markvardsen Patents, Sustancias Activas, S.A. Patent Department, 08028 Barcelona (ES) P.O. Box 114, Favrholmvaenget 40 (72) Inventors: 3400 Hilleroed (DK) • Palacios, Santiago 28001 Madrid (ES) (54) A pharmaceutical product for hormone replacement therapy comprising tibolone or a derivative thereof and estradiol or a derivative thereof (57) A pharmaceutical product comprising an effec- arate or sequential use in a method for hormone re- tive amount of tibolone or derivative thereof, an effective placement therapy or prevention of hypoestrogenism amount of estradiol or derivative thereof and a pharma- associated clinical symptoms in a human person, in par- ceutically acceptable carrier, wherein the product is pro- ticular wherein the human is a postmenopausal woman. vided as a combined preparation for simultaneous, sep- EP 1 522 306 A1 Printed by Jouve, 75001 PARIS (FR) 1 EP 1 522 306 A1 2 Description [0008] The review article of Journal of Steroid Bio- chemistry and Molecular Biology (2001), 76(1-5), FIELD OF THE INVENTION: 231-238 provides a review of some of these compara- tive studies. - 
												
												Modi Dissertation 2012 Submitted To
Distribution Agreement In presenting this thesis or dissertation as a partial fulfillment of the requirements for an advanced degree from Emory University, I hereby grant to Emory University and its agents the non-exclusive license to archive, make accessible, and display my thesis or dissertation in whole or in part in all forms of media, now or hereafter known, including display on the world wide web. I understand that I may select some access restrictions as part of the online submission of this thesis or dissertation. I retain all ownership rights to the copyright of the thesis or dissertation. I also retain the right to use in future works (such as articles or books) all or part of this thesis or dissertation. Signature: ________________________ ______________________ Meera Modi Date Identifying Novel Therapeutic Strategies for Enhancing Social Cognition Using Functional Animal Models By Meera Modi Doctor of Philosophy Graduate Division of Biological and Biomedical Science Neuroscience _________________________________________ Larry Young, PhD Advisor _________________________________________ Lisa Parr, PhD Committee Member _________________________________________ Diana Robins, PhD Committee Member _________________________________________ Randy Hall, PhD Committee Member _________________________________________ Kerry J. Ressler, MD/PhD Committee Member Accepted: _________________________________________ Lisa A. Tedesco, Ph.D. Dean of the James T. Laney School of Graduate Studies ___________________ Date Identifying Novel Therapeutic - 
												
												Female Sexual Interest / Arousal Disorder
Female Sexual Interest / See SSRI sexual dysfunction Arousal Disorder decision support Asse ss for me dica tions w hich Refer to appropriate SSRI may affect sexual function History of physical/sexual/emotional abuse Present psychosocial services other (i.e SSRI, TCA, contraceptives, and/or intimate partner violence? and agencies available Benzodiazepines, antipsychotics) in community Reassess need for medication and transition if Substance use Appropriate Evaluate for partner Obtain full medical/sexual/ disorder? Present See corresponding Sexual dysfunction psychosocial history decision support Comorbid psychiatric Present disorder present? Treat underlyingPresent Evaluate for non-gynecological cause and reassess medical etiology Commorbidity absent Evaluate for gynecological etiology Symptom Is duration greater than 6 months Symptom persistence and causing significant distre ss? persistence Yes Female with Sexual Inte re st Arousa l Disorder Asse ss a nd e sta blish treatment expectations a nd goals Behavior Modification: Lifestyle changes Psychotherapy: Body image Sexual therapy Consider Sleep hygiene Trailored intervention Couples therapy combination therapy Stress reduction Based on H&P Mindfulness Pelvic therapy Relationship building Sexual novelty Inadequate response Continue Psychotherapy and Behavior modification interventions Inadequate response Consider topical oils (i.e. Zestra) in addition to Bupropion Pharmacotherapy Inadequate response Buspirone is less studied, however, it may be useful in some circumstances Postmenopausal? Buspirone No Yes Consider testosterone Flibanserin therapy. Consider consultation Inadequate response Bremelanotide FEMALE SEXUAL INTEREST /AROUSAL DISORDER Bupropion XL Antidepressant DOSING: starting dose 150mg XL qAM. Increase after 1 week to 300mg XL Wellbutrin XL (dopamine and qAM. Target dose 300mg- 450mg XL qAM. Max dose 450mg XL qAM. norepinephrine uptake inhibitor) SIDE EFFECTS: (common) insomnia, nausea, agitation, tremor (rare, serious) seizures, especially in patients with a history of seizures or eating disorders. - 
												
												Bremelanotide in HSDD Presented at the 22Nd Annual Fall Scientific Meeting of 1 2 2 2 3 Sexual Medicine Society of North America Anita H
222 The Neurobiology and Efficacy of Bremelanotide in HSDD Presented at the 22nd Annual Fall Scientific Meeting of 1 2 2 2 3 Sexual Medicine Society of North America Anita H. Clayton, Johna Lucas, Robert Jordan, Carl Spana, James G. Pfaus November 3– 6, 2016 Scottsdale, AZ 1University of Virginia, Charlottesville, VA, USA; 2Palatin Technologies, Cranbury, NJ, USA; 3Concordia University, Montréal, Québec, Canada • Introduction Mechanism of Sexual and Reward Circuitry Rat Study Human Study — Decreased (less distress) both the total score and • These neurochemicals act on similar regions of the brain, • BMT’s downstream CNS effects of increasing arousal • Among premenopausal women with HSDD with or scores on the desire, arousal, and orgasm items of • Female sexual dysfunctions are classified as dysfunctions Sexual Response such as the medial preoptic area (mPOA) in the hypothalamus, and desire are thought to result from its action as a without FSAD, subcutaneous (SC) administration of the FSDS–Desire-Arousal-Orgasm measure. Mean of desire (eg, hypoactive sexual desire disorder [HSDD]), attention- and reward-related regions of the limbic system, MC-receptor agonist BMT 1.25 or 1.75 mg: (SE) change, –11.1 (12.0) vs –6.8 (13.6); BMT vs arousal (eg, female sexual arousal disorder [FSAD]), • Excitatory signals are regulated by dopamine (DA), placebo, respectively ( P=0.0014; Figure 7 )11 and the prefrontal cortex • Among female rats primed with estrogen and proges - — Significantly increased the number of sexually satisfying delay or absence of orgasm, or sexual pain (dyspareunia norepinephrine (NE), oxytocin, and the melanocortins 5,6 — Gamma aminobutyric acid projections help regulate DA terone or estrogen alone, BMT significantly increased events (SSEs) vs placebo when taken 45 minutes or vaginismus) 1 (MCs) Figure 7. - 
												
												Conversations with Women About Female Sexual Dysfunction (FSD)
235 Conversations With Women About Female Sexual Dysfunction (FSD) and Treatment With Bremelanotide Presented at the 22nd Annual Fall Scientific Meeting of 1 2 3 4 5 5 6 Sexual Medicine Society of North America Patricia E. Koochaki , Stanley Althof , Sheryl A. Kingsberg , Michael A. Perelman , Johna Lucas , Robert Jordan , Dennis A. Revicki November 3– 6, 2016 Scottsdale, AZ 1PEK Market Research, Inc., Cincinnati, OH, USA; 2Case Western Reserve University School of Medicine, Cleveland, OH, USA; 3University Hospitals Case Medical Center, Cleveland, OH, USA; 4Weill Cornell Medical College, New York, NY, USA; 5Palatin Technologies, Cranbury, NJ, USA; Evidera, Bethesda, MD, USA • Recognizing There Was a Problem Partner and Relationship Effects Physical Effects of BMT Sexual Satisfaction Increased Summary of Benefits That Women With HSDD With/Without Introduction Results Decreased Arousal During the interviews, women described how they Partner Blamed Himself • About three-quarters of all participants reported experiencing Approximately two-thirds of participants taking 1.25 and 1.75 mg Female sexual dysfunctions (FSD) include a Pre-Study: Conceptualizing and Explaining Why began to recognize they were experiencing sexual “There were a couple of times where he did blame himself. He physical effects from BMT of BMT reported an improvement in sexual satisfaction. range of distressing, multifactorial conditions, They Experienced FSD difficulties that required intervention. thought something was wrong with him.” • Nine of 10 women taking the 1.75-mg dose of BMT reported “A positive way …I think it restored or rebuilt what [sexual such as dysfunctions of sexual interest/desire, • Most women were unaware that FSD is a recognized “Because for a young man our age, he’s thinking like, it must be me.