A Multi-center, Open-label, Single-arm 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Study of Testosterone Cypionate Injection in Hypogonadal Men
Azurity Pharmaceuticals
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
Eligibility
- Age range
- 18–75 years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Male subjects aged ≥18 to ≤75 years of age (inclusive) at time of enrollment. * Body mass index (BMI) ≥17 kg/m\^2 to \< 40 mg\^2. * Willing and able to voluntarily provide written informed consent prior to initiation of screening or study-specific procedures. * Able to understand and to follow the protocol requirements, restrictions, and instruction, in the Investigator's opinion * Diagnosed with primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired). * Hypogonadal males (individual serum testosterone concentrations \<350…
Interventions
- DrugTestosterone 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.
Locations (6)
- Alabama Clinical Therapeutics, LLCBirmingham, Alabama
- Hillcrest Medical Research, LLCDeLand, Florida
- Integrity Clinical Research Center, Inc.Hialeah, Florida
- AccuMed Research AssociatesGarden City, New York
- Aim TrialsPlano, Texas
- Alpine Clinical Organization Inc.Clinton, Utah