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Hormone Therapy

A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism

Phase 4
Waitlist Available
Research Sponsored by Endo Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will study the effect of testosterone on blood pressure in males with primary or secondary hypogonadism. Testim®, Fortesta®, and Aveed® are all forms of testosterone treatment that will be applied or injected over the course of 16 weeks.

Eligible Conditions
  • Hypogonadotropic Hypogonadism
  • Low Testosterone
  • Testicular Hypogonadism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

3Treatment groups
Active Control
Group I: TESTIM (Testosterone Gel)Active Control1 Intervention
50 mg once daily topical gel administration.
Group II: AVEED (Testosterone Undecanoate Injection)Active Control1 Intervention
Fixed dosage level of 750 milligrams (mg)/3 milliliters (mL) administered by intramuscular injections.
Group III: FORTESTA (Testosterone Gel)Active Control1 Intervention
40 mg once daily topical gel administration.

Find a Location

Who is running the clinical trial?

Endo PharmaceuticalsLead Sponsor
135 Previous Clinical Trials
33,025 Total Patients Enrolled
Luis OrtegaStudy DirectorEndo Pharmaceuticals
2 Previous Clinical Trials
649 Total Patients Enrolled
Karen KangStudy DirectorEndo Pharmaceuticals
2 Previous Clinical Trials
318 Total Patients Enrolled
~125 spots leftby Dec 2025
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