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Not yet recruitingNCT07328542Updated Jan 9, 2026

Ambulatory Blood Pressure Monitoring (ABPM) Study in Hypogonadal Men

A Phase 4 interventional study of Testosterone Cypionate Injection 200 mg/mL in Hypogonadism, Male, sponsored by Azurity Pharmaceuticals. Not yet recruiting at 6 sites in United States. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-09.

Sponsored by Azurity Pharmaceuticals · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
144
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
Male
01

Study 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

02

Conditions studied

  • Hypogonadism, Male

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Keywords

  • Hypogonadal Men
  • Ambulatory Blood Pressure Monitoring (ABPM)
03

In context

Eunuchism

75 studies on the registry are indexed under Eunuchism; 21 are open to participants now.

This study's planned enrollment of 144 is above the median of 60 across 55 interventional studies indexed under Eunuchism.

Browse Eunuchism studies →

Lead sponsor

Azurity Pharmaceuticals is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male subjects aged ≥18 to ≤75 years of age (inclusive) at time of enrollment.
  • (BMI) ≥17 kg/m\^2 to \< 40 mg\^2.
  • Willing and able to voluntarily provide written 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 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 >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 ≤ (ULN)
    2. ≤ 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. ≤ 9 %
    6. ≤ 2.5 x ULN
    7. AST ≤ 2.5 x ULN
    8. Serum ≤ 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

Exclusion Criteria:

  • Subjects with known to study drug, including androgens, or product .
  • 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 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 Virus (HBV), Virus (HCV), or (HIV).
  • Participation in any clinical study within 45 days or 5 half-lives of the drug before dosing of 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.
Terms in these criteria, in plain language(16)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
144 participants (estimated)

Study arms

  • Experimental
    Testosterone Cypionate Injection

    Drug: Testosterone Cypionate Injection 200 mg/mL

Interventions

  • DrugTestosterone Cypionate Injection 200 mg/mL

    Drug page: Testosterone 17 beta-cypionate

    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.

06

What researchers measure

Primary outcomes

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

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

Secondary outcomes

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

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

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

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

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

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

  4. Percent of participants taking new antihypertensive medications

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

  5. Percent of participants requiring increases in dose of antihypertensive medications from baseline

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

  6. Number of participants with changes in daytime average systolic blood pressure (SBP)

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

  7. Number of participants with changes in daytime average diastolic blood pressure (DBP)

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

  8. Number of participants with changes in daytime mean arterial pressure (MAP)

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

  9. Number of participants with changes in daytime average pulse pressure

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

  10. Number of participants with changes in daytime average heart rate

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

  11. Number of participants with changes in night time average systolic blood pressure (SBP)

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

  12. Number of participants with changes in night time average diastolic blood pressure (DBP)

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

  13. Number of participants with changes in night time mean arterial pressure (MAP)

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

  14. Number of participants with changes in night time average pulse pressure

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

  15. Number of participants with changes in night time average heart rate

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

  16. Number of participants with drug-related adverse events

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

07

Study locations

6 sites
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07328542
Collaborators
CBCC Global Research
Responsible party
Sponsor
First posted
Jan 9, 2026
Start date
Feb 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Jan 9, 2026

Study contacts

David J. Sequeira, Ph.D.
Contact
david.sequeira@azurity.com
+1 913 389 7961
Balraj Sangha
Contact
balraj.sangha@cbcc.global
+1 510 209 4316

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Testosterone 17 beta-cypionate

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