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- 23.8% of Topical T subjects below 10 million sperm/mL at end of study versus 2.3% and 2.4% respectively for Androxal® and placebo ITT (Androxal® vs. Topical T, p = 0.0031)
- 33.3% reduction from baseline sperm concentration for Topical T subjects versus 5.9% increase for Androxal® subjects ITT (p=0.0004)
- 33.3% responder rate for Topical T versus 65.9% rate for Androxal® ITT (p = 0.0025)
- 16 week treatment with Topical T subsequently suppresses endogenous production of T on cessation of dosing versus baseline T levels (230 ng/dL baseline versus 183 ng/dL one week after dosing stops, p =0.0004)
- Androxal® maintains normal levels of endogenous T one week after dosing cessation (370.9 ng/dL, comparison to Topical T p < 0.0001)
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Repros Therapeutics Inc.® (Nasdaq: RPRX) today reported top line results for the first of two identical pivotal studies comparing Androxal® to a leading FDA approved topical gel (Androgel® 1.62) and placebo. In this study, ZA-305, Androxal® exhibited superiority in several assessments, particularly the two co-primary endpoints: percent change from baseline in average sperm concentration and percent of subjects considered to be responders. A responder is defined as an individual achieving a 24 hour average testosterone in the normal range with associated average sperm concentration ≥ 10 million/mL.Multiple secondary endpoints also showed statistically significant differences between the Androxal® and T gel groups. These include: change in the important pituitary signaling hormones LH and FSH; percent of subjects that become severely oligospermic (< 10 million sperm/mL); induction of hormone dependence via assessment of morning testosterone levels comparing baseline to one week after the end of dosing; and impact on testicular size at the end of the dosing period.
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.