Testosterone Cypionate for Hypogonadism and Blood Pressure
This study is looking at how Testosterone Cypionate Injection 200 mg/mL affects blood pressure in men with hypogonadism (low testosterone). Researchers want to see if this treatment changes your average 24-hour systolic ambulatory blood pressure (the top number in a blood pressure reading, measured over a full day using a portable device). You may be able to join if you are a man between 18 and 75 years old with hypogonadism. The study is currently unclear on its recruitment status. The main goal is to measure changes in your 24-hour blood pressure from the start of the study until the end of treatment, which is about 14 weeks.
- Study design
- This is a Phase 4, multi-center, open-label (you and your doctor will know what treatment you are receiving), single-arm study, meaning all 144 participants will receive the same treatment.
- What's involved
- You will receive Testosterone Cypionate Injection 200 mg/mL every two weeks for a total of 14 weeks. Your blood pressure will be monitored over 24 hours at the beginning and end of treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your blood pressure will be monitored from the start of the study until the end of treatment, up to Week 14 (Day 99).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07328542
Ambulatory Blood Pressure Monitoring (ABPM) Study in Hypogonadal Men
Not Yet Recruiting
PHASE4Ages 18–75InterventionalTreatmentAzurity Pharmaceuticals
~144 participants
Updated 2026-01-09 on ClinicalTrials.gov
What's tested:Testosterone Cypionate Injection 200 mg/mL
At a glance
Recruiting sites
0 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with changes in 24-hour average systolic ambulatory blood pressure
Measured over From Baseline to End of Treatment, up to Week 14 (Day 99)
Conditions
Where it's being run
6 sites across 5 statesFlorida2
Alabama1
New York1
Texas1
Utah1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
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.
What this trial measures
- Number of participants with changes in 24-hour average systolic ambulatory blood pressureFrom Baseline to End of Treatment, up to Week 14 (Day 99)