Ambulatory Blood Pressure Monitoring (ABPM) Study in Hypogonadal Men

NCT07328542 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: AZ-01022-7300-002
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Hypogonadal Men; Ambulatory Blood Pressure Monitoring (ABPM)

Outcome Measures

Primary Outcomes (1)

• Number of participants with changes in 24-hour average systolic ambulatory blood pressure

  From Baseline to End of Treatment, up to Week 14 (Day 99)

Secondary Outcomes (16)

• Number of participants with changes in 24-hour average diastolic ambulatory blood pressure

  From Baseline to End of Treatment, up to Week 14 (Day 99)

• Number of participants with changes in 24-hour average pulse pressure

  From Baseline to End of Treatment, up to Week 14 (Day 99)

• Number of participants with changes in 24-hour average heart rate

  From Baseline to End of Treatment, up to Week 14 (Day 99)

• Percent of participants taking new antihypertensive medications

  From Baseline to End of Treatment, up to Week 14 (Day 99)

• Percent of participants requiring increases in dose of antihypertensive medications from baseline

  From Baseline to End of Treatment, up to Week 14 (Day 99)

Study Arms (1)

Testosterone Cypionate Injection

EXPERIMENTAL

Drug: Testosterone Cypionate Injection 200 mg/mL

Interventions

Testosterone Cypionate Injection 200 mg/mL DRUG

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.

Testosterone Cypionate Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ng/dL and mean serum testosterone concentrations \<300 ng/dL, determined from at least two samples separated at least 48 hours apart and obtained between 6 AM and 10 AM local time).
• Testosterone therapy naïve or has discontinued current treatment and completed adequate washout of prior androgen therapy or any other therapy which causes significant change in serum androgen level i.e., clomiphene, anabolic steroids, compounded or over-the-counter androgenic steroid derivatives and dehydroepiandrosterone (45 days or 5 half-lives of the drug, whichever is longer, prior to collection of baseline serum testosterone samples). Washout must be completed prior to collection of baseline serum testosterone samples to determine study eligibility.
• An office blood pressure measurement \<140 millimeters of mercury (mmHg) for SBP AND \<90 mmHg for DBP.
• If the subject is on an antihypertensive regimen, he has been on stable dose for at least 4 weeks prior to study enrollment.
• If the subject is on glucocorticoids \>7.5 mg prednisone equivalent per day (e.g., hydrocortisone 30 mg, methylprednisolone 6 mg, or dexamethasone 1.2 mg), he has been on stable dose for at least 4 weeks prior to study enrollment with no intention of changing dose for the duration of the study.
• Subjects with acceptable laboratory parameters
• Hematocrit ≤ Upper limit of normal (ULN)
• Hemoglobin ≤ 16 gm%
• Prolactin ≤ ULN
• PSA ≤ 4.0 ng/mL (PSA level between 1.5 to 4.0 ng/mL (both inclusive) for subject who is treated with 5-alpha reductase inhibitors (e.g., dutasteride, finasteride)

You may not qualify if:

• Subjects with known hypersensitivity to study drug, including androgens, or product excipients.
• Subjects with abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or International Prostate Symptom Score (I-PSS) score \> 19 points.
• Subjects with history of, or current or suspected, prostate or breast cancer.
• Subjects with history of any clinically significant illness, infection, or surgical procedure within 4 weeks prior to study enrollment except for diabetes, or renal disease
• Subject with history of fluid or electrolyte imbalance.
• Subject taking anticoagulant.
• Subjects with history of uncontrolled heart failure, stroke or myocardial infarction within the past 6 months.
• Subject with history of severe lower urinary tract symptoms in past 6 months.
• Subjects with history of diagnosed, severe, untreated, obstructive sleep apnea.
• Subjects working night shifts.
• Subjects performing strenuous manual labor or exercise while wearing the ABPM monitor.
• Subjects with chronic atrial fibrillation or any other chronic condition, which interferes with the ability to obtain precise ambulatory recordings.
• Subject with polycythemia.
• Subject with history of thrombophilia or venous thromboembolic events.
• Subject with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).

Sponsors & Collaborators

• Azurity Pharmaceuticals: lead
• CBCC Global Research: collaborator

Study Sites (6)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35235, United States

Location

Hillcrest Medical Research, LLC

DeLand, Florida, 32720, United States

Location

Integrity Clinical Research Center, Inc.

Hialeah, Florida, 33015, United States

Location

AccuMed Research Associates

Garden City, New York, 11530, United States

Location

Aim Trials

Plano, Texas, 75093, United States

Location

Alpine Clinical Organization Inc.

Clinton, Utah, 84015, United States

Location

MeSH Terms

Conditions

Eunuchism

Interventions

testosterone 17 beta-cypionate

Condition Hierarchy (Ancestors)

Hypogonadism; Gonadal Disorders; Endocrine System Diseases

Central Study Contacts

David J. Sequeira, Ph.D.

CONTACT

+1 913 389 7961; david.sequeira@azurity.com

Balraj Sangha

CONTACT

+1 510 209 4316; balraj.sangha@cbcc.global

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 9, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Locations

US (6)