Mithra reaches milestone in estetrol skin study

Mithra, a company dedicated to women’s health, today announces a significant milestone in its ongoing clinical program extension to explore treatments beyond vasomotor symptoms (VMS) in post-menopausal women. An update of this study was last provided on 28 February 2024. Mithra has achieved the last patient randomized (LPR) in this study, marking the culmination of the recruitment phase.

The study, titled "Randomized, double-blind, placebo-controlled, pilot proof-of-concept study to evaluate the effect of estetrol (E4) on skin parameters in postmenopausal women with vasomotor symptoms," was conducted at a single site in Germany. The study randomized a total of 66 postmenopausal women to receive either E4 or placebo over a duration of 6 months.

The primary endpoints of the study are skin elasticity and skin roughness, while key secondary endpoints included collagen content, skin hydration, skin thickness, skin dryness, and quality of life. In addition to dermatological efficacy endpoints, the study also collected gynecological/general safety data, such as treatment-emergent adverse events.

Collection of top-line results is expected to be completed by the end of 2024, with the final clinical study report (CSR) expected by Q2 2025.

Graham Dixon, Chief Scientific Officer of Mithra: "We are excited to have achieved this crucial milestone in our skin study. The completion of patient randomization signifies a significant step forward in our quest to evaluate the effects of estetrol on skin parameters in postmenopausal women with VMS. While no unexpected safety events have been reported thus far, we continue to prioritize the safety and well-being of our study participants, working closely with our medical monitor to ensure thorough oversight. We are optimistic about the potential impact of our findings as we look to further demonstrate the beneficial effects of E4 beyond VMS in postmenopausal women."