Ambulatory Blood Pressure Monitoring (ABPM) Study in Hypogonadal Men
ConditionHypogonadism, Male
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18-75
SponsorAzurity Pharmaceuticals
About this trial
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
Eligibility criteria
Qualifiers
Male subjects aged ≥18 to ≤75 years of age (inclusive) at time of enrollment.
Body mass index (BMI) ≥17 kg/m² to < 40 mg².
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Testosterone Cypionate Injection 200 mg/mL
Treatment groups
144 Participants
are divided into 1 treatment groupSponsors and collaborators
Azurity Pharmaceuticals
Lead sponsor
CBCC Global Research
Collaborator
Source ClinicalTrials.gov