Ambulatory Blood Pressure Monitoring (ABPM) Study in Hypogonadal Men

Recruitment Status
NOT YET RECRUITING
(See Contacts and Locations)Verified December 2025 by Azurity Pharmaceuticals
Sponsor
Azurity Pharmaceuticals
Information Provided by (Responsible Party)
Azurity Pharmaceuticals
Clinicaltrials.gov Identifier
NCT07328542
Other Study ID Numbers:
AZ-01022-7300-002
First Submitted
January 6, 2026
First Posted
January 8, 2026
Last Update Posted
January 8, 2026
Last Verified
December 2025

ClinicalTrials.gov processed this data on January 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Hypogonadism, Male
Drug: Testosterone Cypionate Injection 200 mg/mL

Study Design

Study TypeInterventional
Actual Enrollment144 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA Multi-center, Open-label, Single-arm 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Study of Testosterone Cypionate Injection in Hypogonadal Men
Study Start DateJanuary 31, 2026
Actual Primary Completion Date11mos 4w from now
Actual Study Completion Date1yr 1mo from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Testosterone Cypionate Injection
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.

Outcome Measures

Primary Outcome Measures
  1. Number of participants with changes in 24-hour average systolic ambulatory blood pressure
Secondary Outcome Measures
  1. Number of participants with changes in 24-hour average diastolic ambulatory blood pressure
  2. Number of participants with changes in 24-hour average pulse pressure
  3. Number of participants with changes in 24-hour average heart rate
  4. Percent of participants taking new antihypertensive medications
  5. Percent of participants requiring increases in dose of antihypertensive medications from baseline
  6. Number of participants with changes in daytime average systolic blood pressure (SBP)
  7. Number of participants with changes in daytime average diastolic blood pressure (DBP)
  8. Number of participants with changes in daytime mean arterial pressure (MAP)
  9. Number of participants with changes in daytime average pulse pressure
  10. Number of participants with changes in daytime average heart rate
  11. Number of participants with changes in night time average systolic blood pressure (SBP)
  12. Number of participants with changes in night time average diastolic blood pressure (DBP)
  13. Number of participants with changes in night time mean arterial pressure (MAP)
  14. Number of participants with changes in night time average pulse pressure
  15. Number of participants with changes in night time average heart rate
  16. Number of participants with drug-related adverse events

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyMale
Accepts Healthy VolunteersNo
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 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 1. Hematocrit ≤ Upper limit of normal (ULN) 2. Hemoglobin ≤ 16 gm% 3. Prolactin ≤ ULN 4. 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) 5. HbA1c ≤ 9 % 6. ALT ≤ 2.5 x ULN 7. AST ≤ 2.5 x ULN 8. Serum bilirubin ≤ 2.0 mg/dL
No history of addiction to any recreational drug or drug dependence or alcohol abuse (including illicit steroid use) as per Investigator's judgement.
Subject is not considering fathering a child or donating sperm during the study or for approximately 30 days after the last dose of study drug.
Subject is not currently enrolled in another clinical study and will not enroll in another clinical study throughout the duration of the study.
Exclusion Criteria
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).
Participation in any clinical study within 45 days or 5 half-lives of the drug before dosing of Investigational Product.
Loss of ≥ 350 ml (1 unit) of blood within 30 days of enrollment in the study.
Any other medical condition or serious inter current illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study.

Contacts and Locations

Sponsors and CollaboratorsAzurity Pharmaceuticals
Locations
Alabama Clinical Therapeutics, LLC | Birmingham Alabama, United States, 35235Hillcrest Medical Research, LLC | DeLand Florida, United States, 32720Integrity Clinical Research Center, Inc. | Hialeah Florida, United States, 33015AccuMed Research Associates | Garden City New York, United States, 11530Aim Trials | Plano Texas, United States, 75093Alpine Clinical Organization Inc. | Clinton Utah, United States, 84015