Safety and Efficacy of Weekly Testosterone Cypionate Auto-Injector in Men With Hypogonadism
Public ClinicalTrials.gov record NCT07898072. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Single-Blind, Single-Arm, Multiple-Dose Study Evaluating the Safety and Efficacy of Testosterone Cypionate Administered Subcutaneously Via a Weekly Auto-Injector in Adult Males With Hypogonadism Through Week 24
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT07898072
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 190 participants
Conditions and interventions
Conditions
Interventions
- Testosterone Cypionate 75 mg Drug
- Testosterone cypionate 50 mg Drug
- Testosterone cypionate 100 mg Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 28, 2026 (Actual)
- Primary completion
- Mar 31, 2027 (Estimated)
- Completion
- Dec 31, 2027 (Estimated)
- Last update posted
- Oct 27, 2026
2026 – 2027
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California (UCLA) (Site ID 111) | Santa Monica | California | 90403 | Not yet recruiting |
| Accel Research Site Alcanza Clinical Research (Site ID 103) | DeLand | Florida | 32720 | Not yet recruiting |
| Floridian Clinical Research LLC (Site ID 101) | Miami Lakes | Florida | 33016 | Recruiting |
| Quality Research Center (Site ID 104) | Omaha | Nebraska | 68114 | Recruiting |
| AccuMed Research Associates (Site ID 106) | Garden City | New York | 11530 | Recruiting |
| Integrated Medical Professionals/Advanced Urology Centers of New York (Site ID 107) | New York | New York | 10016 | Not yet recruiting |
| Brown University (Site ID 108) | Providence | Rhode Island | 02904 | Not yet recruiting |
| Coastal Carolina Research Center (Site ID 102) | North Charleston | South Carolina | 29405 | Not yet recruiting |
| Biobehavioral Research Center of Austin (Austin TX) (Site ID 105) | Austin | Texas | 78759 | Recruiting |
| Baylor College of Medicine (Site ID 109) | Houston | Texas | 77030 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07898072, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 27, 2026 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07898072 live on ClinicalTrials.gov.