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Last Updated: November 4, 2024

CLINICAL TRIALS PROFILE FOR FORTESTA


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All Clinical Trials for FORTESTA

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01228071 ↗ Time to Eugonadal Range, Time to Steady State and Drying Time Completed Endo Pharmaceuticals Phase 3 2010-11-01 This is a multicenter, open-label, single arm trial to evaluate the time to eugonadal testosterone range after initial testosterone gel 2% application, time to steady state after after initiation of testosterone gel 2%, and drying time after application of testosterone gel 2%.
NCT01689896 ↗ Testosterone and Pain Sensitivity Withdrawn Endo Pharmaceuticals Phase 4 2012-08-01 This research is being done to see whether testosterone replacement in men who take opioid-based pain medications and have low testosterone levels will show improvement in pain tolerance, pain perception and quality of life. Some men who take opioid-based medications (narcotics) for pain develop low testosterone levels. Research has shown that low testosterone levels may make a person more sensitive to pain. This means that if a person with a painful condition develops low testosterone level as a result of his pain medications, he might become more sensitive to pain and so may need higher doses of pain medications for pain control. Testosterone is a male hormone that is important for sperm production and the development of male characteristics such as muscle mass and strength, fat distribution, bone mass and sex drive. Testosterone hormone replacement therapy has been used for decades to treat men with low testosterone levels (male hypogonadism). Testosterone replacement therapies are available in the form of an injection into the muscle, implants under the skin, oral capsules taken by mouth, topical gels applied to the skin, and skin patches. This study will use Fortesta®, a topical testosterone gel (T-gel) absorbed into the skin. Fortesta® is currently on the market as an FDA-approved treatment of male hypogonadism (low testosterone levels). Men with non-cancer related pain who take opioid-based medications for pain and have low testosterone levels may join this study. (A low testosterone level is defined as early morning (before noon) blood testosterone level of 300 ng/dl or less, or a free testosterone of 50 ng/dl or less)).
NCT01689896 ↗ Testosterone and Pain Sensitivity Withdrawn Johns Hopkins University Phase 4 2012-08-01 This research is being done to see whether testosterone replacement in men who take opioid-based pain medications and have low testosterone levels will show improvement in pain tolerance, pain perception and quality of life. Some men who take opioid-based medications (narcotics) for pain develop low testosterone levels. Research has shown that low testosterone levels may make a person more sensitive to pain. This means that if a person with a painful condition develops low testosterone level as a result of his pain medications, he might become more sensitive to pain and so may need higher doses of pain medications for pain control. Testosterone is a male hormone that is important for sperm production and the development of male characteristics such as muscle mass and strength, fat distribution, bone mass and sex drive. Testosterone hormone replacement therapy has been used for decades to treat men with low testosterone levels (male hypogonadism). Testosterone replacement therapies are available in the form of an injection into the muscle, implants under the skin, oral capsules taken by mouth, topical gels applied to the skin, and skin patches. This study will use Fortesta®, a topical testosterone gel (T-gel) absorbed into the skin. Fortesta® is currently on the market as an FDA-approved treatment of male hypogonadism (low testosterone levels). Men with non-cancer related pain who take opioid-based medications for pain and have low testosterone levels may join this study. (A low testosterone level is defined as early morning (before noon) blood testosterone level of 300 ng/dl or less, or a free testosterone of 50 ng/dl or less)).
NCT04456296 ↗ A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism Recruiting Endo Pharmaceuticals Phase 4 2020-06-30 Testosterone is the principal androgen produced by the male testes. Hypogonadism is the result of inadequate production of testosterone by the Leydig cells of the testes and is reflected by total serum concentrations of testosterone of < 300 ng/dL, with discernible diurnal pattern. The etiology of hypogonadism may be primary or secondary. The treatment of males with primary, and in some cases, secondary Hypogonadism includes administration of testosterone. Testim® and Fortesta® are topical gels that when applied daily help to increase the total testosterone levels in the blood through skin absorption. Aveed® is an injectable form of testosterone treatment and participants randomized to this treatment arm will receive 3 injections over the course of 16 weeks. This study is designed to evaluate the effect on blood pressure of approved testosterone products (Testim®, Fortesta®, and Aveed®) after 16 weeks of therapy using 24-hour Ambulatory blood pressure (ABPM) to reveal shifts in BP levels.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for FORTESTA

Condition Name

Condition Name for FORTESTA
Intervention Trials
Hypogonadism 2
Hypogonadism, Male 1
Hypogonadotropic Hypogonadism 1
Low Testosterone 1
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Condition MeSH

Condition MeSH for FORTESTA
Intervention Trials
Hypogonadism 3
Eunuchism 1
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Clinical Trial Locations for FORTESTA

Trials by Country

Trials by Country for FORTESTA
Location Trials
United States 14
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Trials by US State

Trials by US State for FORTESTA
Location Trials
Texas 2
Florida 2
Maryland 1
South Carolina 1
Michigan 1
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Clinical Trial Progress for FORTESTA

Clinical Trial Phase

Clinical Trial Phase for FORTESTA
Clinical Trial Phase Trials
Phase 4 2
Phase 3 1
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Clinical Trial Status

Clinical Trial Status for FORTESTA
Clinical Trial Phase Trials
Recruiting 1
Withdrawn 1
Completed 1
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Clinical Trial Sponsors for FORTESTA

Sponsor Name

Sponsor Name for FORTESTA
Sponsor Trials
Endo Pharmaceuticals 3
Johns Hopkins University 1
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Sponsor Type

Sponsor Type for FORTESTA
Sponsor Trials
Industry 3
Other 1
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