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Hormone Therapy

AVEED (Testosterone Undecanoate Injection) for Low Testosterone

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 baseline (day 1), week 16
Awards & highlights

Study 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
  • Low Testosterone
  • Testicular Hypogonadism
  • Hypogonadotropic Hypogonadism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1), week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1), week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in 24-Hour Average Systolic Ambulatory Blood Pressure
Secondary outcome measures
Change from Baseline in 24-Hour Average Arterial Pressure
Change from Baseline in 24-Hour Average Diastolic Blood Pressure
Change from Baseline in 24-Hour Average Heart Rate
+4 more

Trial Design

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

Find a Location

Who is running the clinical trial?

Endo PharmaceuticalsLead Sponsor
133 Previous Clinical Trials
34,320 Total Patients Enrolled
Karen KangStudy DirectorEndo Pharmaceuticals
2 Previous Clinical Trials
318 Total Patients Enrolled
Luis OrtegaStudy DirectorEndo Pharmaceuticals
2 Previous Clinical Trials
643 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given its seal of approval to Testosterone undecanoate injection (AVEED)?

"There is a considerable amount of evidence confirming the safety profile of Testosterone undecanoate injection (AVEED), thus its score on our scale was 3 out 4. This is due to this particular intervention being approved for use in Phase 4 clinical trials."

Answered by AI

What medical conditions is Testosterone undecanoate injection (AVEED) frequently prescribed for?

"Testosterone undecanoate injection (AVEED) is mostly used to treat post-menopausal women over the course of 1-5 years. It has also been brought into use to handle hypogonadotropic hypogonadism, orchidectomy and orchitis."

Answered by AI

How many locations are overseeing the operation of this clinical trial?

"This experiment is being hosted at Endo Clinical Trial Site #30 in Beverly Hills, Florida, Endo Clinical Trial Site #31 in Houston, Texas, and Endo Clinical Trial Site #29 Fleming Island Maryland alongside 35 other trial sites."

Answered by AI

Are there vacancies in the experiment for volunteers?

"Absolutely. According to the clinicaltrials.gov portal, this research effort is still seeking participants since its inception on June 30th 2020 and latest update on September 19th 2022. The study has a target of 618 enrollees across 35 medical facilities."

Answered by AI

How many individuals have enrolled in the research protocol?

"Endo Pharmaceuticals, the trial sponsor, needs 618 qualified participants to run this clinical study. To facilitate that process they have opened two sites: Endo Clinical Trial Site #30 in Beverly Hills and Endo Clinical Trial Site #31 located in Houston."

Answered by AI

Has Testosterone undecanoate injection (AVEED) been evaluated in any other studies?

"At present, there are 36 clinical studies in progress related to Testosterone undecanoate injection (AVEED). 5 of those trials are currently at the third phase; with most centered around Houston, Texas. All told, 135 medical centres across the US have opened their doors for this treatment program."

Answered by AI

Who else is applying?

How old are they?
< 18
65+
18 - 65
What site did they apply to?
Endo Clinical Trial Site #22
Endo Clinical Trial Site #4
Endo Clinical Trial Site #2
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What state do they live in?
Virginia
New York
Other
Florida
How many prior treatments have patients received?
0
3+
2
1

Why did patients apply to this trial?

I'm using Adro gel and tadalafil with mixed results. Im interested in finding the best possible treatment for my condition.
PatientReceived 1 prior treatment
I have been diagnosed with hypogonadism and have been getting injections of testosterone cypionate at my primary care doctor's office. I would say the results of the injections have been mixed. Sometimes I am below the normal range and sometimes in the low end of the range. In addition I am being treated for high blood pressure. I am thinking that this study might improve both conditions.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

What are the steps involved? It appears that the testosterone replacement would be something different that I am currently taking. Would my primary care physician be contacted and involved with this study.because of the change in testosterone replacement drugs?
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Phone Call
Most responsive sites:
  1. Endo Clinical Trial Site #22: < 24 hours
  2. Endo Clinical Trial Site #21: < 48 hours
  3. Endo Clinical Trial Site #19: < 48 hours
~145 spots leftby Mar 2025