Clinical Research Directory

Safety and Efficacy of Weekly Testosterone Cypionate Auto-Injector in Men With Hypogonadism

The goal of this Phase 3 clinical trial is to evaluate the safety, efficacy, and usability of a weekly subcutaneous testosterone cypionate auto-injector in adult males with hypogonadism. The main questions it aims to answer are: * Does weekly testosterone cypionate administered using an auto-injector maintain testosterone levels within the normal range in adult males with hypogonadism? * What side effects and safety outcomes occur during treatment with testosterone cypionate auto-injector? * Is the auto-injector easy for participants to use and self-administer? All participants will receive testosterone cypionate administered subcutaneously once weekly through an auto-injector. Treatment will begin at a 75 mg weekly dose, with dose adjustments to 50 mg or 100 mg based on testosterone levels measured during the study. Participants will: * Receive weekly testosterone cypionate injections using an auto-injector for up to 52 weeks. * Attend regular clinic visits for physical examinations, laboratory tests, blood pressure monitoring, and safety assessments. * Provide blood samples to measure testosterone and other hormone levels and evaluate pharmacokinetics. * Complete questionnaires related to symptoms, quality of life, and ease of use of the auto-injector. * Record self-administration and treatment compliance in a study diary. This study will enroll adult males aged 18 to 75 years with hypogonadism and low testosterone concentrations to evaluate treatment through Week 24, with continued safety follow-up through Week 52.

Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism

DITEST is an oral formulation of native testosterone for the treatment of androgen deficiency in men. The study was a Phase 1 clinical study in hypogonadal men, defined according to FDA and Endocrine Society Guidelines, designed to evaluate the pharmacokinetic (PK) characteristics of DITEST, and to assess the safety and tolerability of DITEST in the target population.

Testosterone in Bariatric Patients

Bariatric surgery is an effective method in the treatment of severe obesity and type 2 diabetes mellitus achieving high remission rates. However, weight loss also causes loss of skeletal muscle and bone mass which at least partly could be prevented by exercise and dietary intervention although the counselling of obese and sedentary individuals in order to increase their physical activity presents a challenge. As up to 78.8% of men undergoing bariatric surgery have low levels of testosterone, testosterone therapy could be considered an attractive alternative or supplement to prevent the immense loss of muscle mass during weight loss. Furthermore, low testosterone levels are associated with sarcopenia, insulin resistance, increased body fat, reduced quality of life, loss of libido and reduced sexual function. The study is a long-term randomized, placebo-controlled trial investigating the effects of testosterone therapy combined with exercise and diet counselling on body composition, components of the metabolic syndrome, hormones, inflammation, sexual function and quality of life before and after weight loss in obese, hypogonadal men undergoing bariatric surgery.

Anthropometric, Functional and Lifestyle Factors Associated With Testosterone Levels in Middle-Aged Men

Decreased testosterone levels in middle-aged men are associated with multiple metabolic, functional and psychosocial consequences. Early identification of modifiable factors associated with reduced testosterone levels may facilitate the early identification of men at increased risk of testosterone deficiency and support preventive healthcare strategies. This population-based cross-sectional observational study aims to investigate anthropometric, functional and lifestyle-related factors associated with serum total testosterone levels in middle-aged men. Approximately 600 men aged 35-59 years residing in the Andijan region of Uzbekistan will be recruited. Participants will undergo comprehensive assessment including anthropometric measurements, functional performance tests, standardised questionnaires and laboratory determination of serum total testosterone concentrations. Anthropometric variables will include body mass index, waist circumference, hip circumference, waist-to-hip ratio and waist-to-height ratio. Functional status will be assessed using hand-grip strength, the five-times chair-stand test and the 4-m walk test. Lifestyle-related factors will be assessed using standardised and study-specific questionnaires. Physical activity will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), while dietary habits, sleep characteristics, smoking status, alcohol consumption and psychosocial characteristics will be assessed using a structured study questionnaire. The study aims to identify factors associated with serum total testosterone levels and to develop a predictive model for the early identification of men at increased risk of testosterone deficiency.

Clinical Evaluation of Subcutaneous Testosterone Implants in Men With Symptomatic Hypogonadism

Introduction: Male hypogonadism is a clinical syndrome associated with significant consequences for health and quality of life. In Brazil, approved testosterone replacement therapy options are limited to injectable formulations and transdermal gels, which are often associated with suboptimal adherence. Subcutaneous testosterone implants, already used in the United States and recommended by international guidelines, represent a promising alternative but are not yet available in Brazil. Objective: To evaluate the efficacy, safety, pharmacokinetics, and quality-of-life impact of 200 mg testosterone implants manufactured in Brazil for the treatment of men with symptomatic hypogonadism. Methods: This is a prospective interventional study conducted at the Division of Urology of the Hospital das Clínicas, University of São Paulo School of Medicine (FMUSP). Thirty cisgender hypogonadal men meeting strict inclusion and exclusion criteria will be enrolled. Participants will receive subcutaneous testosterone implants totaling 800 mg and will be followed for six months. Serial blood sampling will be performed to assess hormonal levels (total and free testosterone, LH, FSH, and PSA) and metabolic parameters (lipid profile, body mass index, and waist circumference). Validated questionnaires, including the IIEF-15, ADAM, and WHOQOL-BREF, will be used to evaluate sexual function, hypogonadal symptoms, quality of life, and patient satisfaction. Outcomes: The primary outcome is the ability of the implants to achieve and maintain therapeutic serum testosterone levels (450-800 ng/dL). Secondary outcomes include pharmacokinetic profile (Cmax, half-life, and mean duration), metabolic effects, changes in quality of life, and treatment adherence. Clinical Significance: This study advances the understanding of a testosterone replacement modality that may offer greater convenience for selected patients and for which data on nationally manufactured products are currently lacking. Over a six-month period, the study will investigate laboratory behavior, clinical impact, and patient satisfaction. Relevance and Impact: This is the first study of its kind conducted in Brazil, combining methodological rigor with a robust design to evaluate the safety and efficacy of domestically manufactured testosterone implants. The methodology incorporates detailed ethical and scientific criteria, ensuring high-quality data. The results may support regulatory and clinical decision-making, benefiting patients and potentially contributing to the Brazilian Unified Health System (SUS).

Relationship of the Microenvironment and Male Fertility

Although much is known about the microenvironment of the gut and the vagina, very little has been published on the microenvironment of the seminal plasma. The seminal plasma is the support fluid for sperm, providing nutrients, facilitating sperm transit to the uterus, and promoting fertilization. It is a rich area of research for markers of fertility and treatment targets. The investigators hypothesize that (1) there are significant populations of seminal microorganisms associated with seminal leukocyte counts well below the WHO's cutoff for pyospermia (1 million/mL) that were not previously detected by traditional culturing methods, and (2) there are pathologic populations of bacteria within the gut and semen microbiome which negatively impact overall fertility, by directly or indirectly impairing hormone status. Participants will be recruited from the Male Fertility practice at the University of Illinois-Chicago (UIC). All participants will have infertility, diagnosed as an inability to conceive pregnancy after 12 months of unprotected intercourse. The normal evaluation of these participants is to obtain at least one semen analysis and bloodwork investigating their endocrine profile: total testosterone, estradiol, sex hormone binding globulin (SHBG), luteinizing hormone (LH), follicle-stimulating hormone (FSH), and albumin. Semen volume is typically \>1 mL, and \<0.2 mL is typically used for the semen analysis. If over 1 million/mL round cells are identified, then a Papanicolaou stain would be performed to identify leukocytes. In this study, any semen demonstrated to have round cells would undergo Papanicolaou staining. A portion of the remaining semen, which would typically be discarded, will be sent for microbiome analysis. Secondly, as part of routine care, fertility patients may be started on medications to increase endogenous testosterone (i.e.: clomiphene citrate, anastrozole, etc). Participants started on medications will also be asked to submit a rectal swab for gut microbiome analysis. Routine care is to monitor the hormonal and testicular response with periodic endocrine blood panels and semen analyses; rectal swabs will be requested at these follow-up intervals also. The control group for both hypotheses will be men with clinical infertility with normal semen analyses and hormone profiles.