Coordinator of Research Team
Name Mario Maggi
Position Full Professor of Endocrinology
Name of Research Team/Laboratory Sexual Medicine & Andrology Unit - Department of Experimental and Clinical Biomedical Sciences Mario Serio – University of Florence
telephone number +390552758415
Brief biographical sketch of the Coordinator
Born in Florence (Italy) April 12, 1956
July 1981 - M.D. School of Medicine, University of Florence, Italy
November 1984 – Diplomate Post-Graduate School of Endocrinology, University of Florence
Member of the scientific board of the Doctorate/PhD Program in
Member of the following Scientific Societies
1) Endocrine Society
2) European Society of Endocrinology (ESE)
3) European Academy of Andrology (ECA, Secretary of the European Academy of Andrology 2010-2014
4)European Society for Sexual Medicine (ESSM)
5) Società Italiana di Endocrinologia (SIE)
6) Società Italiana di Andrologia e Medicina della Sessualità (SIAMS, President of the Società Italiana di Andrologia e Medicina della Sessualità, SIAMS 2012-2014
7) Società Italiana Obesiologia (SIO)
8) Società Italiana Medicina Interna
9) President Andrological Sciences Onlus
Member of the editorial board of the following Journals
1) Associate Editor for the Journal of Sexual Medicine
2) Associate Editor for the International Journal of Endocrinology
3) In the Board of the Journal of Endocrinological Investigation
1) Sandra Filippi, PhD - 25/08/1964 (Biologist)
2) Ilaria Cellai, PhD - 07/06/1974 (Biologist)
3) Chiara Corno, PhD student – 17/05/1988 (Biotechnologist)
4) Paolo Comeglio PhD - 03/07/1966 (Biologist)
5) Giulia Rastrelli, MD, PhD – 18/07/1984 (Resident in Endocrinology School)
6) Sarah Cipriani, MD, 01/07/1988 (Resident in Endocrinology School)
7) Francesco Lotti, MD, PhD –23/06/1980 (Endocrinologist)
8) Alessandra Daphne Fisher, MD, PhD – 17/10/1980 (Endocrinologist)
9) Elisa Maseroli, MD, PhD Student – 11/04/1985 (Endocrinologist)
10) Matteo Rossi, MD – 11/10/1977 (Endocrinologist)
11) Jiska Ristori, 08/03/1978 Psychologist
12) Monica Muratori, PhD, 23/06/1962 (Biologist)
Current research interests
Clinical research on erectile dysfunction and hypogonadism: 1) organic and psycho-relational correlates of male sexual dysfunction, 2) cardiovascular risk factors in men with erectile dysfunction, 3) clinical and metabolic correlates of low testosterone, 4) cardiovascular risk associated with low testosterone levels and with testosterone replacement therapy.
Ultrasound: 1) male genital tract and penile color-Doppler ultrasound evaluation in infertile and fertile subjects and in patients with sexual dysfunctions; 2) association of ultrasound features with clinical, seminal and biochemical parameters. In particular, the Unit mainly focuses on the investigation of ultrasound correlates of male infertility, sexual dysfunctions, chronic pelvic pain and on the impact of obesity and metabolic syndrome on sonographic, seminal and sexual parameters.
Female Sexual Dysfunction: organic and psycho-relational determinants of female sexual desire; sexual and psychological symptoms in patients with eating disorders (e.g. anorexia nervosa), metabolic alterations (e.g. obesity) and history of sexual trauma; effects of oral contraceptives containing androgenic progestins compared with other contraceptives on sexuality; effects of sex steroids on clitoral Doppler parameters; effect of alterations of thyroid function on female sexuality; organic and psycho-relational correlates of genito-pelvic pain/penetration disorder.
Gender Dysphoria in adulthood and adolescence: effects of CHT on hormonal and metabolic parameters, bone density, anthropometric characteristics, as well as physical well-being of GD persons (European Network for the Investigation of Gender Incongruence, ENIGI); psychobiological correlates of gender dysphoria, particularly in terms of body uneasiness and psychopathological symptoms; psychobiological effects of gender transition; transphobia and homophobia levels in general population and healthcare providers; Psychobiological correlates of gender dysphoria in adolescence.
Basic research of hypogonadism and sexual medicine: The laboratory basic research activities focused mainly on:
• Pathophysiology of the erectile function and investigation of the urogenital tract derangements induced by metabolic syndrome (MetS), diabetes and hypertension, by means of ex-vivo and in-vitro studies in rabbit and rat animal models
• Bladder, prostate and corpora cavernosa dysfunction in animal models, with particular focus on the effects of PDE5 inhibitors and sexual hormones on the underlying pathogenetic mechanisms
• Effect of physical activity on penile erection and peripheral vascular districts functional alterations induced by high-fat diet in an animal model of MetS
• Effect of the changing sex-steroid milieu on clitoris function in a rat model of ovariectomy
• Studies on adipose tissue dysregulation and liver dysfunction associated with MetS features, including LUTS and inflammation, focusing on the role of androgen/estrogen ratio in pre-adipocytes from visceral adipose tissue in the rabbit animal model of MetS
• Mechanisms regulating differentiation and function of gonadotropin-releasing hormone neurons in humans and MetS animal models
Basic research in sperm biology:
- Study of DNA fragmentation in the viable sperm fraction of the ejaculate: comparison of infertile and fertile subjects and effect of the selection procedures used in Assisted Reproduction technologies.
- Cellular and nuclear oxidative stress in the viable sperm fraction of the ejaculate: detection in infertile men and in cancer patients
- Study of methods of semen cryopreservation: effect on motility, viability, DNA integrity and levels of oxidative stress of human spermatozoa
- Use of an in vitro model for studying mechanisms originating sperm DNA fragmentation and testing molecules with antioxidant and antiapoptotic properties.
Current / recent sources of funding
1) Unit Coordinator of Research Project funded by PRIN (Programmi di Ricerca di Rilevante Interesse Nazionale). Funds by the Italian Minister of University, research and Instruction: On the pleiotropic role of type 5 phosphodiesterase (Year 2015: - prot. 2015XCR88M_002)
2) Year 2015: Funding Source(s) INTERCEPT PHARMACEUTICALS (USA) - Effects of chronic treatment with the selective FXR agonist obeticholic acid (OCA) in bleomycin-induced pulmonary fibrosis rat model
3) Year 2015: Funding Source(s) INTERCEPT PHARMACEUTICALS (USA). Effects of chronic treatment with the selective FXR agonist obeticholic acid (OCA) on walking distance post treadmill exercise in monocrotaline-induced pulmonary hypertensive rat model
4) Year 2015: Funding Source(s) INTERCEPT PHARMACEUTICALS (USA). Study of the effect of INT-767 on preadipocyte differentiation capacity
5) Year 2015 Funding Source(s) Ely Lilly - I5E-MC-TSAT A Randomized, Double-Blind, Placebo-Controlled Parallel Study with an Open-Label Extension to Assess the Impact of Testosterone Solution on Total Testosterone, Sex Drive and Energy in Hypogonadal Men
6) Year 2015 Funding Source(s) Bayer HealthCare - Study of the effect of testosterone treatment on metabolic parameters and LUT function in bariatric patients. An observational study
7) Year 2016 Funding Source(s) Bayer HealthCare - Study of the effect of testosterone treatment on inflammatory parameters and clinical scores in patients with Crohn disease. An observational study
8) Year 2016: Funding Source(s) INTERCEPT PHARMACEUTICALS (USA). Study of the effect of FXR/TGR5 dual agonist on functional and fibrotic alterations induced by metabolic syndrome in peripheral vascular districts
10 best publications of the last 5 years
1) Morelli A, Comeglio P, Filippi S, Sarchielli E, Vignozzi L, Maneschi E, Cellai I, Gacci M, Lenzi A, Vannelli GB, Maggi M.
Mechanism of action of phosphodiesterase type 5 inhibition in metabolic syndrome-associated prostate alterations: An experimental study in the rabbit.
Prostate. 73: 428-41, 2013.
2) Maneschi E, Vignozzi L, Morelli A, Mello T, Filippi S, Cellai I, Comeglio P, Sarchielli E, Calcagno A, Mazzanti B, Vettor R, Vannelli GB, Adorini L, Maggi M.
FXR activation normalizes insulin sensitivity in visceral preadipocytes of a rabbit model of MetS.
J Endocrinol. 218: 215-31, 2013.
3) Comeglio P, Morelli A, Cellai I, Vignozzi L, Sarchielli E, Filippi S, Maneschi E, Corcetto F, Corno C, Gacci M, Vannelli GB, Maggi M.
Opposite effects of tamoxifen on metabolic syndrome-induced bladder and prostate alterations: a role for GPR30/GPER?
Prostate. 74:10-28, 2014.
4) Morelli A, Sarchielli E, Comeglio P, Filippi S, Vignozzi L, Marini M, Rastrelli G, Maneschi E, Cellai I, Persani L, Adorini L, Vannelli GB, Maggi M.
Metabolic syndrome induces inflammation and impairs gonadotropin-releasing hormone neurons in the preoptic area of the hypothalamus in rabbits.
Mol Cell Endocrinol. 382:107-19, 2014.
5) Vignozzi L, Filippi S, Comeglio P, Cellai I, Sarchielli E, Morelli A, Rastrelli G, Maneschi E, Galli A, Vannelli GB, Saad F, Mannucci E, Adorini L, Maggi M.
Nonalcoholic steatohepatitis as a novel player in metabolic syndrome-induced erectile dysfunction: An experimental study in the rabbit.
Mol Cell Endocrinol. 384: 143-54, 2014.
6) Lotti F, Maggi M.
Hum Reprod Update. 21:56-83, 2015.
7) Corona G, Vignozzi L, Sforza A, Mannucci E, Maggi M.
Obesity and late-onset hypogonadism.
Mol Cell Endocrinol. 418 Pt 2:120-33, 2015.
8) Fisher AD, Castellini G, Ristori J, Casale H, Cassioli E, Sensi C, Fanni E, Amato AM, Bettini E, Mosconi M, Dèttore D, Ricca V, Maggi M.
Cross-Sex Hormone Treatment and Psychobiological Changes in Transsexual Persons: Two-Year Follow-Up Data.
J Clin Endocrinol Metab. 101:4260-4269, 2016.
9) Lotti F, Corona G, Castellini G, Maseroli E, Fino MG, Cozzolino M, Maggi M.
Semen quality impairment is associated with sexual dysfunction according to its severity.
Hum Reprod. 31:2668-2680, 2016.
10) Corona G, Rastrelli G, Morgentaler A, Sforza A, Mannucci E, Maggi M.
Meta-analysis of Results of Testosterone Therapy on Sexual Function Based on International Index of Erectile Function Scores.
Eur Urol. 2017 Apr 20. [Epub ahead of print]
Previous research experiences
Prof. Mario Maggi worked as :
Professor of Endocrinology at the Post-Graduate School of Endocrinology, University of Pisa (1992-1994)
Professor of Endocrinology at the Post-Graduate School of Endocrinology, University of Florence (1992-2006)
Professor of Andrology at the Post-Graduate School of Obstetric and Ginecology, University of Florence (1993-2004)
Aiuto Medico at the Andrology, Azienda Ospedaliera Careggi (1993-2000)
Professor of Endocrinology, University of Brescia (1996-2004)
Full Professor of Endocrinology at the University of Florence (September 2000 – ongoing)
Main scientific contributions
- Unit Coordinator of Research Project funded by PRIN (Programmi di Ricerca di Rilevante Interesse Nazionale). Funds by the Italian Minister of University, research and Instruction: On the pleiotropic role of type 5 phosphodiesterase (Year 2015: - prot. 2015XCR88M_002).
- Member of an international research project (European Network for the Investigation of Gender Incongruence, ENIGI) in collaboration with the Department of Endocrinology, VU University Medical Center, Amsterdam (The Netherlands), the Department of Endocrinology, University of Ghent (Belgium) and the Department of Endocrinology, Oslo University Hospital, Oslo (Norway).
- Member of an Italian Network on gender dysphoria (together with the Gender Identity Development Service Hospital S. Camillo-Forlanini, Rome; the Center for Reproductive Health, Department of Obstetrics and Gynecology, S. Orsola Hospital, University of Bologna, Bologna, the C.I.D.I.GeM, City of Health and Science—Le Molinette Hospital, Turin; Endocrinology and Medical Sexology, Experimental Medicine, University of L’Aquila.
- Member of an international research project (AGIR) with the Gender Centre of the VU University Medical Center of Amsterdam (The Netherlands) and the gender teams of Ghent, Oslo, London, Hamburg, Boston and Toronto.
The Unit has been involved in the following industry supported multicentre international clinical trials:
- BAY 98-7081/14694: A prospective, randomized, double-blind, double-dummy, placebo and active controlled, multicentre study assessing the efficacy and safety of the combination BAY 60-4552/vardenafil compared to vardenafil (20 mg) for the treatment of erectile dysfunction not sufficiently responsive to standard therapy with PDE5 inhibitors. Sub-Investigator, BayerHealthCare.
- Premature Ejaculation-Actual Use Safety and Effectiveness Study (PAUSE). Investigator, Janssen-Cilag International N.V. An observational study.
- I5E-MC-TSAT A Randomized, Double-Blind, Placebo-Controlled Parallel Study with an Open-Label Extension to Assess the Impact of Testosterone Solution on Total Testosterone, Sex Drive and Energy in Hypogonadal Men.
The Unit has been involved in the following non-supported multicentre international clinical trials:
- Registry of Hypogonadism in Men (RHYME), Clinical Research Associate, New England Research Institute, Inc. An observational study.
- Standardization of male genital tract colour-Doppler ultrasound parameters in healthy, fertile men. SUsPHeM, an EAA project. An observational study.
The Unit has been involved in the following non-supported multicentre national clinical trials:
- Cardiovascular Outcome of Replacement with Testosterone (CORTe). An observational study.
- SIAMsO-NOI: Società Italiana di Andrologia e Medicina della sessualità Osservatorio Nazionale Outcome Ipogonadismo. An observational study.
The Unit also started non-supported single-centre clinical trials, designed and performed in the centre itself:
- Effectiveness of Testosterone Replacement Therapy (TRT) on Prostatic Gland in Hypogonadal Patients Affected by Benign Prostatic Hyperplasia (BPH) and Metabolic Syndrome (MetS). Florence-PROTEST. NCT02366975. A double-blind, Placebo-controlled Study.
- Vardenafil and Cognitive-behavioral Sex Therapy for the Treatment of Erectile Dysfunction (STEDOV). An interventional randomized clinical trial.
- Double-blind, Placebo-controlled Study on Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia to Assess Changes in Pressure Flow Study and in Molecular Profile of Prostatic Tissue After 12 Weeks Treatment With Tadalafil. NCT02252367.
- Study of the effect of testosterone treatment on metabolic parameters and LUT function in bariatric patients. An observational study.
- Study of the effect of testosterone treatment on inflammatory parameters and clinical scores in patients with Crohn disease. An observational study.
6. Collaborations with other Units of the University/Hospital
- Center of Assisted Reproductive Tecnology, Careggi Teaching Hospital (Prof. E. Coccia),
- EAA Training Center of Rome, Department of Medical Pathophysiology University "La Sapienza" Rome, Italy (Prof. A. Lenzi, Dr. A.M. Isidori ),
- EAA Andrology Training Center, Endocrinology, Andrology Unit, Department of Medicine and Applied Biotechnologies, Polytechnic University of Marche, Italy (Prof. G. Balercia),
- University of L'Aquila, L'Aquila, Italy (Prof. EA. Jannini),
- Diabetes Agency, Careggi Teaching Hospital, Florence, Italy (Prof. E. Mannucci; Dr. M. Monami),
- Department of Anatomy, Histology and Forensic Medicine, University of Florence, Florence, Italy (Prof. G.B. Vannelli; Prof. A. Morelli),
- Psychiatric Unit, Department of Neuropsychiatric Sciences, Florence University School of Medicine, Firenze, Italy (Prof. V. Ricca, Dr. G. Castellini),
- Department of Urology, University of Florence, Florence, Italy (Prof. M. Carini, Dr. M. Gacci, Dr. A. Natali),
- Andrology Research Unit, Centre for Endocrinology and Diabetes, Institute of Human Development, Faculty of Medical and Human Sciences, University of Manchester (Prof. F. Wu),
- Division of Endocrinology and Metabolic Diseases, Department of Internal Medicine, University of Turin, Turin, Italy (Prof. C. Manieri),
- Department of Endocrinology, VU University Medical Center, Amsterdam, The Netherlands (Prof Martin Den Heijer),
- Department of Medical Psychology, VU University Medical Center, Amsterdam, The Netherlands (Prof Peggy Cohen-Kettenis),
- University of Modena and Reggio Emilia (Prof. M. Simoni).
Howewer, the Center has entered into the educational program “Prevention in andrology” of the Italian Ministry of Health and the Italian Society of Andrology and Sexual Medicine (SIAMS).