(122) POSITIVE EFFECTS OF BREMELANOTIDE ON FEMALE SEXUAL AROUSAL AND ORGASM IN PREMENOPAUSAL WOMEN WITH HSDD: FSFI DATA FROM THE RECONNECT TRIALS
Notice bibliographique
Résumé
Abstract Introduction Bremelanotide is a melanocortin receptor agonist approved by the FDA as an as-needed treatment for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. In phase 3 clinical trials, bremelanotide treatment resulted in a statistically significant increase in the mean sexual desire domain score of the Female Sexual Function Index (FSFI) compared to the placebo group and significantly decreased distress associated with low sexual desire. However, the effects of bremelanotide on sexual function have not been completely characterized. Objective To assess the effects of bremelanotide over time on arousal and orgasmic function in premenopausal women diagnosed with HSDD. Methods Two randomized, placebo-controlled, multi-institutional phase 3 clinical trials (RECONNECT) were conducted in premenopausal women diagnosed with acquired, generalized HSDD. Study participants were randomized to either placebo or bremelanotide (1.75 mg/0.3 mL subcutaneous injection; Vyleesi®) and were instructed to dose approximately 45 minutes before sexual activity. Previously unreported data on arousal and orgasm domain scores of the FSFI were analyzed by monthly assessments from baseline to the end of trial at 24 weeks. Investigators at study sites obtained approval for this trial from local institutional review boards in the US or from independent ethics committees in Canada. All study participants provided informed consent. All data were expressed as change from baseline and differences between bremelanotide and placebo at each assessment time were analyzed by Krusal-Wallis test using SAS version 9.3. Results Baseline FSFI arousal domain scores ranged from 2.61 to 2.64 in the bremelanotide group and 2.56 to 2.57 in the placebo group. Baseline FSFI orgasm domain scores ranged from 2.93 to 3.11 in the bremelanotide group and 2.94 to 3.03 in the placebo group. In both studies, at the first post-dosing assessment at 4 weeks, FSFI arousal and FSFI orgasm domain scores were significantly higher in the bremelanotide group (23-25% and 16-21% increase over baseline for arousal and orgasm, respectively) than the placebo group (5-10% and 0-9 % increase over baseline for arousal and orgasm, respectively). Arousal and orgasm domain scores for the bremelanotide group remained significantly higher than placebo throughout the study and continuously increased to the end of the study at 24 weeks. In contrast, study participants treated with placebo experienced a smaller increase in arousal and orgasm domain scores, which plateaued and subsequently declined between weeks 16 and 20. Conclusions Bremelanotide, dosed as needed approximately 45 minutes before sexual activity, facilitated sexual arousal and orgasm in premenopausal women diagnosed with HSDD. Improvements occurred within the first month of dosing and continued to increase over 24 weeks. These findings underscore the interdependence of various aspects of sexual function and demonstrate that treating HSDD can improve other aspects of the sexual response. Disclosure Yes, this is sponsored by industry/sponsor: Cosette Pharmaceuticals, Palatin. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Cosette Pharmaceuticals.
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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 | 0,005 | 0,005 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| 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 ».