dose-response relationships in healthy young men;
and Dose Finding of a Potent Aromatase Inhibitor, Aromasin (Exemestane), in Young Males
-Dose Human Chorionic Gonadotropin Maintains Intratesticular Testosterone in Normal Men with Testosterone-Induced Gonadotropin Suppression
of clomiphene citrate to reverse premature andropause secondary to steroid abuse.
in the Endocrinological Milieu After Clomiphene Citrate Treatment for Oligozoospermia: The Clinical Significance of the Estradiol/Testosterone Ratio as a Prognostic Value
steroidogenesis after human chorionic gonadotropin desensitization in rats.
of tamoxifen on GH and IGF-1 serum level in stage I-II breast cancer patients
of gynecomastia with tamoxifen: A double-blind crossover study
of testosterone/estradiol ratio in predicting the efficacy of tamoxifen citrate treatment in idiopathic oligoasthenoteratozoospermic men.
The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) medication guide for Testosterone. For Testosterone Undecanoate, REMS includes elements to assure safe use and implementation system . For additional information: /REMS
US BOXED WARNINGS :
Pulmonary Oil Microembolism (POME) Reactions And Anaphylaxis :
-Serious POME reactions, involving urge to cough, dyspnea, throat tightening, chest pain, dizziness, and syncope; and episodes of anaphylaxis, including life-threatening reactions, have been reported to occur during or immediately after the administration of testosterone undecanoate injection. These reactions can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose.
-Following each injection of testosterone undecanoate observe patients in the healthcare setting for 30 minutes in order to provide appropriate medical treatment in the event of serious POME reactions or anaphylaxis.
Secondary Exposure To Topical Testosterone :
-Virilization has been reported in children who were secondarily exposed to topical testosterone products.
-Children should avoid contact with unwashed or unclothed application sites in men using testosterone topical.
-Healthcare providers should advise patients to strictly adhere to recommended instructions for use.
Safety and efficacy have not been established in patients younger than 18 years.
Testosterone Enanthate and Testosterone Implant are indicated for delayed puberty in adolescent patients.
Testosterone Cypionate: Safety and efficacy have not been established in patients younger than 12 years.
Consult WARNINGS section for additional precautions.
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