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* The primary end point for the study is the change in total motile sperm count at 16 weeks. Secondary outcome measures include sperm DNA fragmentation index, normalization of serum total testosterone levels, plasma and semen concentrations of leflutrozole, changes in libido, safety, and other parameters.
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www.urologytimes.com
The trial is evaluating the efficacy of leflutrozole in improving testicular function and promoting spermatogenesis.
The first patient has been enrolled in a phase 2 trial (NCT06993155) evaluating leflutrozole (RPN-001), an orally administered aromatase inhibitor under investigation for the treatment of infertility in men with low serum testosterone levels, ReproNovo announced in a news release.1
According to the company, “Male-factor infertility is implicated in up to half of infertility cases worldwide. Currently, no FDA-approved oral therapies exist for men with this diagnosis.”
Leflutrozole works by inhibiting the enzyme aromatase, which then suppresses the conversion of testosterone to estradiol, thereby normalizing testosterone levels.
“RPN-001 has the potential to offer clinicians a new way to increase the amount of functional sperm available for fertility treatments based on a well-understood biological pathway,” said Joan-Carles Arce, MD, PhD, Chief Scientific and Medical Officer of ReproNovo, in the news release.1 “With this phase 2 study now underway, we are taking the next step toward addressing a clear and growing unmet need in reproductive medicine.”
In total, the double-blind phase 2 trial plans to enroll approximately 200 patients across clinical trial sites in the US.
To be eligible for enrollment, patients need to be aged 18 to 49 years and have serum sex hormone binding globulin levels and serum estradiol levels within or above the normal range at screening as well as serum luteinizing hormone levels within or below the normal range at screening. Additionally, participants need to demonstrate a low total motile sperm count on 2 samples as well as a semen volume of 1.0 mL or lower on 2 samples.2
Overall, the investigators are assessing the efficacy of leflutrozole in improving testicular function and promoting spermatogenesis.
The agent will be evaluated across 3 dose levels. Participants will be randomly assigned to receive oral leflutrozole at 0.05 mg (dose 1), 0.1 mg (dose 2), or 0.3 mg (dose 3) once weekly for 16 weeks or to matching placebo. Participants will return to the clinic every 4 weeks and provide semen samples to measure changes in semen quality and undergo blood tests to measure hormone levels.
The primary end point for the study is the change in total motile sperm count at 16 weeks. Secondary outcome measures include sperm DNA fragmentation index, normalization of serum total testosterone levels, plasma and semen concentrations of leflutrozole, changes in libido, safety, and other parameters.
Final study completion is expected in November 2026.
“Initiating this phase 2 study marks a significant milestone in our efforts to bring forward new solutions for the many couples affected by male-factor infertility,” said Jean M. Duvall, CEO of ReproNovo, in the news release.1 “Low testosterone levels are becoming more prevalent, even in younger men, highlighting the urgent demand for new treatments. Our goal is to develop a targeted, well-tolerated therapy that expands options for men and reduce the burden on female partners.”
In addition to leflutrozole, ReproNovo is also developing the oral compound nolasiban (RPN-002) to manage adenomyosis and to increase the probability of embryo implantation in women undergoing assisted reproductive technology treatments. Nolasiban is an oxytocin receptor antagonist that is also in phase 2 development.
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Study launches of first-in-class aromatase inhibitor for male infertility
The trial is evaluating the efficacy of leflutrozole in improving testicular function and promoting spermatogenesis.
The trial is evaluating the efficacy of leflutrozole in improving testicular function and promoting spermatogenesis.
The first patient has been enrolled in a phase 2 trial (NCT06993155) evaluating leflutrozole (RPN-001), an orally administered aromatase inhibitor under investigation for the treatment of infertility in men with low serum testosterone levels, ReproNovo announced in a news release.1
According to the company, “Male-factor infertility is implicated in up to half of infertility cases worldwide. Currently, no FDA-approved oral therapies exist for men with this diagnosis.”
Leflutrozole works by inhibiting the enzyme aromatase, which then suppresses the conversion of testosterone to estradiol, thereby normalizing testosterone levels.
“RPN-001 has the potential to offer clinicians a new way to increase the amount of functional sperm available for fertility treatments based on a well-understood biological pathway,” said Joan-Carles Arce, MD, PhD, Chief Scientific and Medical Officer of ReproNovo, in the news release.1 “With this phase 2 study now underway, we are taking the next step toward addressing a clear and growing unmet need in reproductive medicine.”
In total, the double-blind phase 2 trial plans to enroll approximately 200 patients across clinical trial sites in the US.
To be eligible for enrollment, patients need to be aged 18 to 49 years and have serum sex hormone binding globulin levels and serum estradiol levels within or above the normal range at screening as well as serum luteinizing hormone levels within or below the normal range at screening. Additionally, participants need to demonstrate a low total motile sperm count on 2 samples as well as a semen volume of 1.0 mL or lower on 2 samples.2
Overall, the investigators are assessing the efficacy of leflutrozole in improving testicular function and promoting spermatogenesis.
The agent will be evaluated across 3 dose levels. Participants will be randomly assigned to receive oral leflutrozole at 0.05 mg (dose 1), 0.1 mg (dose 2), or 0.3 mg (dose 3) once weekly for 16 weeks or to matching placebo. Participants will return to the clinic every 4 weeks and provide semen samples to measure changes in semen quality and undergo blood tests to measure hormone levels.
The primary end point for the study is the change in total motile sperm count at 16 weeks. Secondary outcome measures include sperm DNA fragmentation index, normalization of serum total testosterone levels, plasma and semen concentrations of leflutrozole, changes in libido, safety, and other parameters.
Final study completion is expected in November 2026.
“Initiating this phase 2 study marks a significant milestone in our efforts to bring forward new solutions for the many couples affected by male-factor infertility,” said Jean M. Duvall, CEO of ReproNovo, in the news release.1 “Low testosterone levels are becoming more prevalent, even in younger men, highlighting the urgent demand for new treatments. Our goal is to develop a targeted, well-tolerated therapy that expands options for men and reduce the burden on female partners.”
In addition to leflutrozole, ReproNovo is also developing the oral compound nolasiban (RPN-002) to manage adenomyosis and to increase the probability of embryo implantation in women undergoing assisted reproductive technology treatments. Nolasiban is an oxytocin receptor antagonist that is also in phase 2 development.
