The primary endpoint was the percentage of patients with C avg within the normal range (greater than or equal to 300 ng/dL and less than or equal to 1140 ng/dL) on Day 90. In patients treated with FORTESTA, % (100/129) had C avg within the normal range on Day 90. The secondary endpoint was the percentage of patients with C max above three pre-determined limits. The percentages of patients with C max greater than 1500 ng/dL, and between 1800 and 2499 ng/dL on Day 90 were % and %, respectively. No patient had a C max greater than or equal to 2500 ng/dL on Day 90.
DHT concentrations increased in parallel with testosterone concentrations at AndroGel 1% doses of 50 mg/day and 100 mg/day, but the DHT/T ratio stayed within the normal range, indicating enhanced availability of the major physiologically active androgen. Serum estradiol (E2) concentrations increased significantly within 30 days of starting treatment with AndroGel 1% 50 or 100 mg/day and remained elevated throughout the treatment period but remained within the normal range for eugonadal men. Serum levels of SHBG decreased very slightly (1 to 11%) during AndroGel 1% treatment. In men with hypergonadotropic hypogonadism, serum levels of LH and FSH fell in a dose- and time-dependent manner during treatment with AndroGel 1%.
Current practice states that men with prostate cancer should not receive testosterone as it is thought to accelerate an active case. Note that testosterone is not thought to cause prostate cancer, but may speed up the severity of the disease. Men who are, or have been treated for prostate cancer are at risk for the fatigue and decreased libido of low testosterone as well. Since hormone replacement is typically not recommended for this group, other options are needed. A special combination of two forms of the nutritional supplement carnitine has shown equal effectiveness in battling fatigue and maintaining well being [Source: Cavallini ]. This combination contains 2,000 mg of acetyl L-carnitine and 2,000 mg of propionyl L-carnitine. The heart benefits that are seen with testosterone replacement have not been studied with this combination.