Amneal Pharmaceuticals, LLC
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.
Hypogonadism in adult males is characterized by inadequate testosterone production and may be associated with reduced energy, decreased libido, diminished muscle mass and strength, impaired physical function, and other clinical symptoms. Testosterone replacement therapy is commonly used to restore serum testosterone concentrations to the normal physiological range and improve symptoms associated with testosterone deficiency. This Phase 3, multicenter, single-arm, multiple-dose study is designed to evaluate the long-term efficacy, safety, pharmacokinetic profile, and usability of testosterone…
Inclusion Criteria: * Adults assigned male at birth, aged 18 to 75 years. * Documented diagnosis of hypogonadism (low testosterone) with at least one associated symptom, such as reduced sexual desire, erectile dysfunction, fatigue, reduced energy, loss of muscle mass, decreased body hair, or mood changes. * Fasting morning serum total testosterone concentration below 300 ng/dL on two separate occasions, at least 72 hours apart, during screening. One additional test may be allowed if one of the initial measurements is 300 ng/dL or higher. * Body mass index (BMI) between 18.5 and 39.9 kg/m². *…
Testosterone cypionate injectable solution formulated in cottonseed oil, supplied in a single-use auto-injector containing 75 mg/0.5 mL. The study drug will be administered subcutaneously into the abdomen once weekly. All participants will initiate treatment at 75 mg once weekly, with dose adjustments in 25 mg increments to 50 mg or 100 mg based on serum total testosterone trough concentrations according to protocol-defined criteria. Treatment will continue through the 24-week primary evaluation period, with eligible participants permitted to continue once-weekly treatment through Week 52 for extended safety assessment.
Testosterone cypionate injectable solution formulated in cottonseed oil, supplied in a single-use auto-injector containing 50 mg/0.5 mL. The study drug will be administered subcutaneously into the abdomen once weekly. All participants will initiate treatment at 75 mg once weekly, with dose adjustments in 25 mg increments to 50 mg or 100 mg based on serum total testosterone trough concentrations according to protocol-defined criteria. Treatment will continue through the 24-week primary evaluation period, with eligible participants permitted to continue once-weekly treatment through Week 52 for extended safety assessment.
Testosterone cypionate injectable solution formulated in cottonseed oil, supplied in a single-use auto-injector containing 100 mg/0.5 mL. The study drug will be administered subcutaneously into the abdomen once weekly. All participants will initiate treatment at 75 mg once weekly, with dose adjustments in 25 mg increments to 50 mg or 100 mg based on serum total testosterone trough concentrations according to protocol-defined criteria. Treatment will continue through the 24-week primary evaluation period, with eligible participants permitted to continue once-weekly treatment through Week 52 for extended safety assessment.