Arletta Pharma Solutions has announced encouraging results from its phase II clinical study evaluating Lybrido, a combination therapy of testosterone and sildenafil, for women suffering from Female Sexual Interest/Arousal Disorder (FSIAD). The study met its primary endpoint, demonstrating significant improvement in physiological markers of sexual arousal and confirming the optimal dose for further clinical development.

The investigator-initiated study was conducted at Chaim Sheba Medical Centre and involved 16 premenopausal women diagnosed with acquired generalised FSIAD. Researchers used Clitoral Doppler Duplex Ultrasound (CDU) to measure clitoral blood flow, a key biomarker of genital arousal. Participants were administered either a standard or high-dose combination of testosterone and sildenafil.

Results showed that both dose combinations led to more than a 60 percent average improvement in Peak Systolic Velocity (PSV), indicating enhanced blood flow. Notably, the higher dose combination achieved statistical significance, providing strong evidence of a consistent physiological response despite the limited sample size.

The findings also validated Lybrido’s dual mechanism of action, combining the central effects of testosterone on sexual desire with the peripheral effects of sildenafil, a phosphodiesterase-5 (PDE5) inhibitor, on blood flow. Researchers noted that this is the first time objective biomarker data have confirmed the efficacy of the high-dose combination in women with FSIAD.

Company executives highlighted that the results significantly de-risk the ongoing clinical development programme. The study also aligns with earlier research suggesting that combination therapy offers superior outcomes compared to single-agent treatments in female sexual dysfunction.

Based on these findings, Arletta Pharma is planning a pivotal study in Europe and is evaluating the launch of an additional phase II trial in the United States to further assess the safety and efficacy of the high-dose regimen.

FSIAD remains one of the most common female sexual disorders, affecting an estimated 8 percent of women globally and significantly impacting quality of life and emotional well-being. Currently, treatment options remain limited, highlighting a substantial unmet medical need.

Lybrido is an investigational, on-demand therapy designed to address both psychological and physiological aspects of sexual dysfunction. Its dual-release formulation ensures synchronised action, enhancing sexual motivation and genital response within a controlled time window.