Not Yet RecruitingPhase 4

Ambulatory Blood Pressure Monitoring (ABPM) Study in Hypogonadal Men

United States144 participantsStarted 2026-02

Plain-language 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

Who can participate

Age range18 Years – 75 Years

SexMALE

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Inclusion criteria

✓. 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

What they're measuring

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

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

Trial details

NCT IDNCT07328542

SponsorAzurity Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

David J. Sequeira, Ph.D.

+1 913 389 7961 david.sequeira@azurity.com

View on ClinicalTrials.gov More Hypogonadism, Male trials