Testosterone Cypionate for Hypogonadism
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for men aged 18 to 75 who have low testosterone due to hypogonadism or testicular problems. Participants must be able to use an auto-injector and attend regular clinic visits.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Testosterone Cypionate
Trial Overview
The study tests weekly self-injections of testosterone cypionate (50, 75, or 100 mg) using an auto-injector in men with low testosterone. All participants receive the treatment, and doses may be adjusted based on blood levels over up to one year.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Participants with hypogonadism will receive testosterone cypionate injection administered subcutaneously into the abdomen once weekly using an auto-injector. All participants will initiate treatment at 75 mg once weekly.
Participants with hypogonadism will receive testosterone cypionate injection administered subcutaneously into the abdomen once weekly using an auto-injector. All participants will initiate treatment at 75 mg once weekly. The dose may be adjusted to 50 mg based on serum total testosterone trough concentrations and protocol-defined dose titration criteria.
Participants with hypogonadism will receive testosterone cypionate injection administered subcutaneously into the abdomen once weekly using an auto-injector. All participants will initiate treatment at 75 mg once weekly. The dose may be adjusted to100 mg based on serum total testosterone trough concentrations and protocol-defined dose titration criteria. Treatment will continue through the 24-week primary evaluation period. Participants completing Week 24 may continue once-weekly treatment with ongoing safety assessments through Week 52. The first dose will be administered by designated study personnel, followed by participant self-administration as specified in the protocol.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amneal Pharmaceuticals, LLC
Lead Sponsor
Avant Sante Research Center S.A. de C.V.
Collaborator
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