(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
Notice bibliographique
Résumé
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
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,026 | 0,006 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».