Clinical trial evidence on emerging pharmacological therapies for hypoactive sexual desire disorder in women: a systematic review and analysis of completed studies registered on ClinicalTrials.gov.

Background: Hypoactive Sexual Desire Disorder (HSDD) is a prevalent and distressing condition affecting adult women and is associated with significant impairments in quality of life and interpersonal relationships. Despite increasing recognition of female sexual health as a clinical priority, pharmacological treatment options for HSDD remain limited, and evidence from individual clinical trials remains heterogeneous. Therefore, a systematic evaluation of registered clinical trials is essential to better understand therapeutic development, efficacy endpoints, and safety profiles of emerging treatments. Methods: This systematic review was conducted in accordance with PRISMA 2020 guidelines using a structured search of ClinicalTrials.gov. Completed interventional clinical trials evaluating pharmacological therapies for HSDD in adult women were identified using predefined eligibility criteria. Data were extracted on study design, participant characteristics, investigational agents, efficacy outcomes related to sexual desire and distress, and reported safety outcomes. Findings were synthesized descriptively without pooled quantitative analysis. Results: A total of nine completed pharmacological clinical trials met the inclusion criteria. Most were Phase II and Phase III randomized, double-blind, placebo-controlled studies, primarily enrolling premenopausal women with acquired, generalized HSDD. Investigational therapies predominantly targeted central nervous system pathways, with flibanserin and bremelanotide representing the most extensively studied agents. Efficacy outcomes commonly included validated patient-reported measures such as the Female Sexual Function Index desire domain and the Female Sexual Distress Scale; however, endpoint designation and reporting completeness varied across trials. Safety data were inconsistently reported, with adverse events reflecting the pharmacological mechanisms of the agents studied. Conclusion: The findings highlight both progress and persistent gaps in the pharmacological treatment landscape for HSDD. Variability in trial design, outcome measures, and reporting practices limits cross-trial comparison and clinical interpretation. Further research with standardized methodologies and comprehensive reporting is needed to strengthen the evidence base.