Male Hypogonadism clinical trials at UCLA

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.