Hypogonadism, MalePhase 4NCT07328542
Ambulatory Blood Pressure Monitoring (ABPM) Study in Hypogonadal Men
A Phase 4 study testing Testosterone Cypionate Injection 200 mg/mL in people with Hypogonadism, Male, run by Azurity Pharmaceuticals at 6 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Hypogonadism, Male
- What is being tested?
- Testosterone Cypionate Injection 200 mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2026to Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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)
- HbA1c ≤ 9 %
- ALT ≤ 2.5 x ULN
- AST ≤ 2.5 x ULN
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235
Alpine Clinical Organization Inc.
Clinton, Utah, 84015
Hillcrest Medical Research, LLC
DeLand, Florida, 32720
AccuMed Research Associates
Garden City, New York, 11530
Integrity Clinical Research Center, Inc.
Hialeah, Florida, 33015
Aim Trials
Plano, Texas, 75093
About this study
Official title: A Multi-center, Open-label, Single-arm 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Study of Testosterone Cypionate Injection in Hypogonadal Men
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
- Being tested
- Testosterone Cypionate Injection 200 mg/mL
- Keywords
- Hypogonadal Men, Ambulatory Blood Pressure Monitoring (ABPM)
- Medical subject headings
- Eunuchism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone Cypionate Injection 200 mg/mLDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Testosterone Cypionate Injection | Experimental | Not described Receives: Drug: Testosterone Cypionate Injection 200 mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with changes in 24-hour average systolic ambulatory blood pressure
Measured: 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
Measured: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with changes in 24-hour average pulse pressure
Measured: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with changes in 24-hour average heart rate
Measured: From Baseline to End of Treatment, up to Week 14 (Day 99)
Percent of participants taking new antihypertensive medications
Measured: From Baseline to End of Treatment, up to Week 14 (Day 99)
Percent of participants requiring increases in dose of antihypertensive medications from baseline
Measured: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with changes in daytime average systolic blood pressure (SBP)
Measured: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with changes in daytime average diastolic blood pressure (DBP)
Measured: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with changes in daytime mean arterial pressure (MAP)
Measured: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with changes in daytime average pulse pressure
Measured: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with changes in daytime average heart rate
Measured: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with changes in night time average systolic blood pressure (SBP)
Measured: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with changes in night time average diastolic blood pressure (DBP)
Measured: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with changes in night time mean arterial pressure (MAP)
Measured: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with changes in night time average pulse pressure
Measured: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with changes in night time average heart rate
Measured: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with drug-related adverse events
Measured: From Baseline to End of Treatment, up to Week 14 (Day 99)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypogonadism, MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azurity Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CBCC Global Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328542
- Sponsor's protocol ID
- AZ-01022-7300-002
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Single-arm 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Study of Testosterone Cypionate Injection in Hypogonadal Men
- ClinicalTrials.gov ID
- NCT07328542
- Acronym / sponsor ID
- AZ-01022-7300-002
- Conditions
- Hypogonadism, Male
- Keywords
- Hypogonadal Men, Ambulatory Blood Pressure Monitoring (ABPM)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Azurity PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- CBCC Global Research
- Study start
- Feb 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Testosterone Cypionate Injection | Experimental | Drug: Testosterone Cypionate Injection 200 mg/mL |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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).
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone Cypionate Injection 200 mg/mLParticipants 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. | Drug | Testosterone Cypionate Injection |
Primary outcome
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)
16 secondary outcomes
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)
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)
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)
Percent of participants taking new antihypertensive medications
Time frame: From Baseline to End of Treatment, up to Week 14 (Day 99)
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)
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)
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)
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)
Number of participants with changes in daytime average pulse pressure
Time frame: From Baseline to End of Treatment, up to Week 14 (Day 99)
Number of participants with changes in daytime average heart rate
Time frame: From Baseline to End of Treatment, up to Week 14 (Day 99)
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)
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)
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)
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)
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)
Number of participants with drug-related adverse events
Time frame: From Baseline to End of Treatment, up to Week 14 (Day 99)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Testosterone Cypionate Injection 200 mg/mL in people with Hypogonadism, Male, run by Azurity Pharmaceuticals at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David J. Sequeira, Ph.D. (+1 913 389 7961, david.sequeira@azurity.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.