(215) Design of the ALETTA Clinical Study: A Randomized Double-Blind Placebo-Controlled Study investigating the Efficacy and Safety of LybridoTM in Premenopausal Women with Acquired FSIAD
Authors: Reisman Y , Vignozzi L , Nappi R , Corona G , Den Hollander W , Van der Mooren J , Giraldi A 
Published: May 2023

Abstract

Introduction
Low sexual desire is the most common sexual complaint in women. As a result, many women suffer from sexual dissatisfaction and related distress which often negatively interferes with their quality of life. Currently, limited drug treatments are available globally to treat women with Hypoactive Sexual Desire Disorder/Female Sexual Interest & Arousal Disorder (FSIAD). Consequently, there is an unmet need, and relevance to developing a drug treatment for women with sexual dysfunction. LybridoTM is a novel on-demand dual-route/dual release fixed-dose combination tablet of sublingual testosterone and oral sildenafil, with the aim to synergistically enhance both central and peripheral processes. It has shown a promising efficacy and safety profile in Phase 2 and is ready for Phase 3 testing.

Objective
Description of a study design to evaluate two-dose strength and compared to placebo for the treatment of FSIAD

Methods
A double-blind, randomized, placebo-controlled, 3-arm, 6-month study to evaluate the efficacy and safety of LybridoTM in premenopausal women with acquired FSIAD. An interim analysis will be performed and overseen by an independent Data Monitoring Committee, to re-estimate the sample size according to predefined criteria. Study Population: European premenopausal women, at least 18 years of age, with a clinical diagnosis of acquired FSIAD. Study Duration: Up to 4-week screening period, followed by a 4-week wash-out baseline period, 24-week treatment period, and 4-week safety follow-up period. Interventions: The study drug is a fixed-dose combination tablet consisting of an inner core containing sildenafil with an outer delayed immediate release coating and an additional outer film coating containing testosterone. Two dose strengths will be evaluated and compared with a placebo.

Results
Primary endpoint: change from baseline to Week 24 in sexual desire assessed by Female Sexual Function Index Desire Domain (FSFI-D) (Items 1 and 2). Secondary efficacy endpoints: sexual distress assessed by Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) score for Item 13; Elements of Desire Questionnaire (EDQ) ‘event-based’ (ie, within 24 hours of a sexual or dosing event); sexual arousal assessed by FSFI Arousal Domain (FSFI-A); sexual function assessed by FSFI total score; sexual distress assessed by FSDS-DOA total score; the number of satisfying sexual events (SSEs) using the Sexual Satisfaction of an Event Questionnaire (SSEQ), reported within 24 hours and assessed relative to the total number of sexual events; patient-reported impression of improvement assessed by the Patient Global Impression of Improvement (PGI-I) Scale; patient-reported impression of severity assessed by the Patient Global Impression of Severity (PGI-S) Scale; and the total number of sexual events. Safety outcomes: frequency of (serious) adverse events.

Conclusions
First Patient In: Q1 2023; Interim Analysis: Q4 2023; Last Patient Out: Q2 2024.

Disclosure
Yes, this is sponsored by industry/sponsor: Freya

Clarification
Industry initiated, executed and funded study
Any of the authors act as a consultant, employee or shareholder of an industry for: Freya