Ambulatory Blood Pressure Monitoring (ABPM) Study in Hypogonadal Men

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Azurity Pharmaceuticals
Study ID
NCT07328542
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Hypogonadism, Male

Eligibility Criteria

Sex
MALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Testosterone Cypionate Injection 200 mg/mL — DRUG
    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 Details

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

Key Dates

Start date
Feb 28, 2026
Status verified
Jan 2026
Primary completion
Jun 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
144 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Testosterone Cypionate Injection

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) ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Alabama Clinical Therapeutics, LLCBirminghamAlabama35235-
Hillcrest Medical Research, LLCDeLandFlorida32720-
Integrity Clinical Research Center, Inc.HialeahFlorida33015-
AccuMed Research AssociatesGarden CityNew York11530-
Aim TrialsPlanoTexas75093-
Alpine Clinical Organization Inc.ClintonUtah84015-

Find similar trials in Birmingham, AL

By research site
Alabama Clinical Therapeutics, LLC· Birmingham, ALHillcrest Medical Research, LLC· DeLand, FLIntegrity Clinical Research Center, Inc.· Hialeah, FLAccuMed Research Associates· Garden City, NYAim Trials· Plano, TXAlpine Clinical Organization Inc.· Clinton, UT

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