Effects of Testosterone Undecanoate Administered Alone or in Combination with Letrozole or Dutasteride in Female to Male Transsexuals

Authors

  • Maria Cristina Meriggiola MD, PhD,

    Corresponding author
    1. Center for Reproductive Health, Department of Obstetrics and Gynecology, S. Orsola Hospital, University of Bologna, Bologna, Italy;
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  • Francesca Armillotta MD,

    1. Center for Reproductive Health, Department of Obstetrics and Gynecology, S. Orsola Hospital, University of Bologna, Bologna, Italy;
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  • Antonietta Costantino PhD,

    1. Center for Reproductive Health, Department of Obstetrics and Gynecology, S. Orsola Hospital, University of Bologna, Bologna, Italy;
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  • Paola Altieri MD,

    1. Center for Reproductive Health, Department of Obstetrics and Gynecology, S. Orsola Hospital, University of Bologna, Bologna, Italy;
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  • Farid Saad DVM,

    1. Scientific Affairs Men's Healthcare, Bayer Schering Pharma, Berlin, Germany;
    2. Gulf Medical University, Ajman, United Arab Emirates;
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  • Thomas Kalhorn PhD,

    1. Department of Medicinal Chemistry, University of Washington, Seattle, WA, USA
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  • Anna Myriam Perrone MD,

    1. Center for Reproductive Health, Department of Obstetrics and Gynecology, S. Orsola Hospital, University of Bologna, Bologna, Italy;
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  • Tullio Ghi MD,

    1. Center for Reproductive Health, Department of Obstetrics and Gynecology, S. Orsola Hospital, University of Bologna, Bologna, Italy;
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  • Carlotta Pelusi MD,

    1. Center for Reproductive Health, Department of Obstetrics and Gynecology, S. Orsola Hospital, University of Bologna, Bologna, Italy;
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  • Giuseppe Pelusi MD

    1. Center for Reproductive Health, Department of Obstetrics and Gynecology, S. Orsola Hospital, University of Bologna, Bologna, Italy;
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Maria Cristina Meriggiola, MD, PhD, Center for Reproductive Health, Gynecology and Obstetrics Unit, University of Bologna, S. Orsola Hospital, Via Massarenti 13––Bologna, Italy 40138. Tel: (39) 051-6363716; Fax: (39) 051-6363716; E-mail: cristina.meriggiola@unibo.it

ABSTRACT

Introduction.  Testosterone undecanoate (TU) has potential as androgen therapy for ovariectomized female to male (FtM) transsexual subjects; however, the long-term physiologic effects of TU treatment, the significance of testosterone (T), and the T metabolites dihydrotestosterone (DHT) and estradiol (E) on specific outcome parameters are currently unknown.

Aim.  The aim of this study was to investigate the long-term treatment of TU with regard to bone metabolism, body composition, and lipid profile in FtM subjects, and to evaluate the relationship between observed effects and circulating levels of T, E, and DHT.

Main Outcome Measures.  Circulating follicle-stimulating hormone, luteinizing hormone, T, E, DHT, and lipid concentrations were measured, as well as bone metabolism, body composition, and insulin resistance.

Methods.  This was a 1-year, randomized treatment, open-label, uncontrolled safety study. Fifteen ovariectomized FtM subjects from an outpatient clinic were divided into three groups to receive TU 1,000 mg alone or in combination with oral administration of letrozole (L) 2.5 mg/die or dutasteride (D) 0.5 mg/die for a period of 54 weeks.

Results.  TU alone and TU + D treatments were successful in terms of hormone adjustment, did not result in any adverse effects, and were well-tolerated. Bone mineral density decreased by an average of 0.9 g/cm2 in the TU + L group, and the addition of D resulted in a failure to gain lean mass.

Conclusions.  This study confirmed that TU is a successful and safe treatment for FtM subjects. These data indicate that E has an important role in bone metabolism and that DHT may play a role in muscle metabolism. Meriggiola MC, Armillotta F, Costantino A, Altieri P, Saad F, Kalhorn T, Perrone AM, Ghi T, Pelusi C, and Pelusi G. Effects of testosterone undecanoate administered alone or in combination with letrozole or dutasteride in female to male transsexuals. J Sex Med 2008;5:2442–2453.

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