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Acerus Pharmaceuticals Corporation - New Data Demonstrates That NATESTO® Increases Serum Testosterone and Improves Symptoms While Maintaining Normal Semen Parameters in Men With Low Testosterone Through Six Months
NEW DATA DEMONSTRATES THAT NATESTO® INCREASES SERUM TESTOSTERONE AND IMPROVES SYMPTOMS WHILE MAINTAINING NORMAL SEMEN PARAMETERS IN MEN WITH LOW TESTOSTERONE THROUGH SIX MONTHS
10/17/2019
TORONTO--(BUSINESS WIRE)-- Acerus Pharmaceuticals Corporation (TSX:ASP, OTCQB:ASPCF) today announced the presentation of data from the NATESTO® Spermatogenesis Study as part of the “Late Breaking” Abstract Session at the 75th Annual American Society for Reproductive Medicine (ASRM) Scientific Conference in Philadelphia, PA. Yesterday’s presentation was one of only six abstracts accepted as part of this session.
Findings from the study demonstrated that 95% of men treated with NATESTO® for hypogonadism for three and six months, maintained their semen parameters within the normal range while increasing serum testosterone levels to normal and improving hypogonadal symptoms. This is the first such study to demonstrate conclusively that a testosterone replacement therapy (TRT) can maintain key fertility parameters in hypogonadal men. Researchers attributed these findings to NATESTO®’s fast absorption and unique dosing schedule designed to produce fluctuations of testosterone levels in the bloodstream.
“Low testosterone affects about 12% of men under 40, at a time when their interest in having a family may be highest. Unfortunately, the therapies we use to restore testosterone levels can impact sperm production and function, resulting in infertility,” said Ranjith Ramasamy, MD, Associate Professor and Director of Reproductive Urology at the University of Miami School of Medicine and the study’s principal investigator. “Our study shows that NATESTO® can be a good option for these men. After six months of treatment, the majority of patients in our study were able to maintain normal levels of sperm production and quality. Any patient with a modest decrease in sperm parameters returned to their pre-study sperm levels within three months of stopping treatment, something we don’t often see with other testosterone replacement therapies.”
The Phase IV, single-site, prospective study evaluated hypogonadal men, ages 18 to 55, who completed up to a six-month treatment period with NATESTO®. The primary endpoints examined:
In total, 55 men were eligible and enrolled in the trial. Of the 55 who enrolled, 33 patients have completed the six-month treatment period.
Nearly all subjects completing the six-month treatment period had their testosterone levels return to the normal range. Mean (SD) serum testosterone levels increased from 230 (62) ng/dL at baseline to 605 (278) ng/dL at six months (p=0.005). In addition, mean baseline levels of Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) (3.9 IU/mL and 4.0 IU/mL, respectively) were preserved within the normal range over this time (2.6 IU/mL and 3.0 IU/mL, respectively).
Most importantly, mean semen parameters remained unchanged (P > 0.05):
Additionally, there was improvement across all domains of erectile function including libido and overall sexual satisfaction, as well as improvement in overall energy, which are common hypogonadal symptoms.
No serious adverse events (AEs) were reported in the study. The most commons AEs were nasal irritation (five cases, 13.1%), oligospermia (three cases, 7.9%) and azoospermia (one case, 2.6%). All of these men recovered spermatogenesis after discontinuation.
“For the first time, a testosterone replacement therapy has been proven to increase serum testosterone while actually maintaining sperm concentration, motility, and total motile sperm count,” said Ed Gudaitis, President and Chief Executive Officer of Acerus. “This clearly differentiates NATESTO® from other approved testosterone therapies. We’re very excited by the outcomes of this study and will look to further develop the growing evidence-base supporting NATESTO®.”
NEW DATA DEMONSTRATES THAT NATESTO® INCREASES SERUM TESTOSTERONE AND IMPROVES SYMPTOMS WHILE MAINTAINING NORMAL SEMEN PARAMETERS IN MEN WITH LOW TESTOSTERONE THROUGH SIX MONTHS
10/17/2019
- NATESTO ® shown to significantly increase mean testosterone levels, while maintaining sufficient gonadotropins to preserve fertility
- Improvement in quality-of-life, overall satisfaction and sexual desire was reported
- Approximately 65% of men become infertile when prescribed other testosterone therapies for six months; recovery is not assured following discontinuation of these therapies1,2
TORONTO--(BUSINESS WIRE)-- Acerus Pharmaceuticals Corporation (TSX:ASP, OTCQB:ASPCF) today announced the presentation of data from the NATESTO® Spermatogenesis Study as part of the “Late Breaking” Abstract Session at the 75th Annual American Society for Reproductive Medicine (ASRM) Scientific Conference in Philadelphia, PA. Yesterday’s presentation was one of only six abstracts accepted as part of this session.
Findings from the study demonstrated that 95% of men treated with NATESTO® for hypogonadism for three and six months, maintained their semen parameters within the normal range while increasing serum testosterone levels to normal and improving hypogonadal symptoms. This is the first such study to demonstrate conclusively that a testosterone replacement therapy (TRT) can maintain key fertility parameters in hypogonadal men. Researchers attributed these findings to NATESTO®’s fast absorption and unique dosing schedule designed to produce fluctuations of testosterone levels in the bloodstream.
“Low testosterone affects about 12% of men under 40, at a time when their interest in having a family may be highest. Unfortunately, the therapies we use to restore testosterone levels can impact sperm production and function, resulting in infertility,” said Ranjith Ramasamy, MD, Associate Professor and Director of Reproductive Urology at the University of Miami School of Medicine and the study’s principal investigator. “Our study shows that NATESTO® can be a good option for these men. After six months of treatment, the majority of patients in our study were able to maintain normal levels of sperm production and quality. Any patient with a modest decrease in sperm parameters returned to their pre-study sperm levels within three months of stopping treatment, something we don’t often see with other testosterone replacement therapies.”
The Phase IV, single-site, prospective study evaluated hypogonadal men, ages 18 to 55, who completed up to a six-month treatment period with NATESTO®. The primary endpoints examined:
- Hormones, including testosterone, hydroxyprogesterone (a marker of endogenous testosterone production), luteinizing hormone (LH) and follicle stimulating hormone (FSH) at three and six months;
- Sperm parameters, including sperm concentration, motility, and total motile sperm count at three and six months; and
- Symptoms of low testosterone as measured by the SF-36, and the International Index of Erectile Dysfunction (IIEE) at three and six months.
In total, 55 men were eligible and enrolled in the trial. Of the 55 who enrolled, 33 patients have completed the six-month treatment period.
Nearly all subjects completing the six-month treatment period had their testosterone levels return to the normal range. Mean (SD) serum testosterone levels increased from 230 (62) ng/dL at baseline to 605 (278) ng/dL at six months (p=0.005). In addition, mean baseline levels of Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) (3.9 IU/mL and 4.0 IU/mL, respectively) were preserved within the normal range over this time (2.6 IU/mL and 3.0 IU/mL, respectively).
Most importantly, mean semen parameters remained unchanged (P > 0.05):
Additionally, there was improvement across all domains of erectile function including libido and overall sexual satisfaction, as well as improvement in overall energy, which are common hypogonadal symptoms.
No serious adverse events (AEs) were reported in the study. The most commons AEs were nasal irritation (five cases, 13.1%), oligospermia (three cases, 7.9%) and azoospermia (one case, 2.6%). All of these men recovered spermatogenesis after discontinuation.
“For the first time, a testosterone replacement therapy has been proven to increase serum testosterone while actually maintaining sperm concentration, motility, and total motile sperm count,” said Ed Gudaitis, President and Chief Executive Officer of Acerus. “This clearly differentiates NATESTO® from other approved testosterone therapies. We’re very excited by the outcomes of this study and will look to further develop the growing evidence-base supporting NATESTO®.”
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