NCT07328542

Ambulatory Blood Pressure Monitoring (ABPM) Study in Hypogonadal Men

A Multi-center, Open-label, Single-arm 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Study of Testosterone Cypionate Injection in Hypogonadal Men

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Azurity Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Phase 4, multi-center, open-label, single-arm 24-hour Ambulatory Blood Pressure Monitoring (ABPM) study of Testosterone Cypionate Injection in Hypogonadal Men to assess change in 24-hour ambulatory blood pressure from Baseline to End of Treatment

Conditions

• Hypogonadism, Male

Interventions

Type	Name	Description
DRUG	Testosterone Cypionate Injection 200 mg/mL	Participants will receive Testosterone Cypionate Injection 200 mg/mL at established dose during the titration and treatment periods every two weeks (± 2 days) as a deep intramuscular injection in the gluteal muscle for 14-week study duration.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-06-01
• Completion: 2027-08-01
• First posted: 2026-01-09
• Last updated: 2026-01-09

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study