Skip to main content
MedPathMedPath Home
Clinical Trials/NCT07328542
NCT07328542
Not yet recruiting
Phase 4

A Multi-center, Open-label, Single-arm 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Study of Testosterone Cypionate Injection in Hypogonadal Men

Azurity Pharmaceuticals9 sites in 1 country144 target enrollmentStarted: February 1, 2026Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
InterventionsTestosterone Cypionate Injection 200 mg/mL

Overview

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Azurity Pharmaceuticals
Enrollment
144
Locations
9
Primary Endpoint
Number of participants with changes in 24-hour average systolic ambulatory blood pressure
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

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\^
  • •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.

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.

Arms & Interventions

Testosterone Cypionate Injection

Experimental

Intervention: Testosterone Cypionate Injection 200 mg/mL (Drug)

Outcomes

Primary Outcomes

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

  • 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))
  • Number of participants with changes in daytime average systolic blood pressure (SBP)(From Baseline to End of Treatment, up to Week 14 (Day 99))
  • Number of participants with changes in daytime average diastolic blood pressure (DBP)(From Baseline to End of Treatment, up to Week 14 (Day 99))
  • Number of participants with changes in daytime mean arterial pressure (MAP)(From Baseline to End of Treatment, up to Week 14 (Day 99))
  • Number of participants with changes in daytime average pulse pressure(From Baseline to End of Treatment, up to Week 14 (Day 99))
  • Number of participants with changes in daytime average heart rate(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)(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)(From Baseline to End of Treatment, up to Week 14 (Day 99))
  • Number of participants with changes in night time average pulse pressure(From Baseline to End of Treatment, up to Week 14 (Day 99))
  • Number of participants with changes in night time mean arterial pressure (MAP)(From Baseline to End of Treatment, up to Week 14 (Day 99))
  • Number of participants with changes in night time average heart rate(From Baseline to End of Treatment, up to Week 14 (Day 99))
  • Number of participants with drug-related adverse events(From Baseline to End of Treatment, up to Week 14 (Day 99))

Investigators

Sponsor
Azurity Pharmaceuticals
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (9)

Loading locations...

Similar Trials

Completed
Not Applicable
Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes
NCT07282054Tonghua Dongbao Pharmaceutical Co.,Ltd550
Not yet recruiting
Not Applicable
A Study of Teprotumumab N01 in Subjects With Active Thyroid Eye Disease
NCT07265258Innovent Biologics (Suzhou) Co. Ltd.92
Recruiting
Phase 3
The Efficacy and Safety of Inpegsomatropin Injection in Children With Short Stature Born Small for Gestational Age
NCT07309562Xiamen Amoytop Biotech Co., Ltd.141
Recruiting
Phase 2
A Phase II Study of PEG-rhGH Injection for Short Children Born Small for Gestational Age: Efficacy, Safety, and Pharmacokinetics
NCT07260500Changchun GeneScience Pharmaceutical Co., Ltd.72
Recruiting
Phase 1
A Clinical Trial of EHT102 Injection in Pediatric Patients With Biallelic hOTOF Mutations
NCT07288580Shanghai Euhearing Therapeutics Co., Ltd30