Standards for Clinical Trials in Sexual Dysfunction in Women: Research Designs and Outcomes Assessment

Abstract

Introduction Clinical trial design in female sexual dysfunction (FSD) is an evolving science, with some areas of controversy. Aim To develop an evidence-based, expert consensus-report on design of FSD clinical research. Methods Literature review including the Food and Drug Administration (FDA) clinical trial guidelines with critique by six experts from three countries, modified after public presentation and debate. Main Outcome Measure Expert opinion and recommendations were based on grading of evidence based literature, internal committee dialogue, open presentation, and debate. Results Design of clinical research for regulatory approval is driven by FDA guidelines. Diagnostic and Statistical Manual-IV definitions and consideration of comorbidity of sexual disorders may complicate patient selection and outcomes. Measures for study end points include satisfying sexual events utilizing a daily diary, sexual distress, and patient-reported outcomes measures of the construct under study. Currently, trial duration is recommended to be 6 months for efficacy trials to allow for modification of behavioral adaptations to changes in desire. Important issues include safety assessments, generalizability, having a representative study population, stratification by reproductive status, partner assessment, contextual and interpersonal factors, symptom duration and severity, management of placebo response, and drug dosing. Statistical analysis should include assessment of change from baseline to end point between study drug and placebo, determination of statistically significant change vs. clinically meaningful effects, linear mapping of all measures of the same construct, and determination of responders and remitters. Conclusions Future trials should include clear population definitions, direct and indirect measures of the specific FSD construct, and procedures to allow generalizability of diagnosis and treatment to the target population.

Does pelvic floor muscle training improve female sexual function? A systematic review

“…Furthermore, the authors modified the specific original response options for each domain. Modification of a tool requires psychometric testing in order to confirm measurement properties of the new tool being used [3].…”

“…Sexual dysfunction is defined as the disturbance in sexual desire and psychophysiological changes that characterise the sexual response and cause interpersonal difficulty and marked distress [3]. Sexual dysfunction significantly affects a woman's quality of life and self-esteem [4].…”

Función Sexual Tras 9 Meses De Una Histerectomía : Comparación De Los Resultados Del Cuestionario De Salud Sexual Fsm® Versus Percepción Subjetiva De La Mujer

“…La fisiología de la respuesta sexual viene extensamente descrita en los múltiples trabajos del Dr. Mas [38][39][40][41] . A continuación expondré un resumen orientado a ver qué aspectos de la fisiología de la RS pueden verse afectados por la histerectomía.…”

“…La disfunción sexual femenina es considerada como una amplia gama de trastornos con notable solapamiento entre los mismos 39 o, como expresa Clayton en su revisión sobre Deseo sexual hipoactivo: "los trastornos sexuales son a menudo concomitantes" como por ejemplo el hecho de que el deseo sexual hipoactivo se asocie con trastornos de la excitación o con dificultades en el orgasmo frecuentes en las mujeres postmenopáusicas 40 . Así mismo, las mujeres con Trastorno por deseo sexual hipoactivo tienen más probabilidades de estar insatisfechas con su vida sexual y con su relación de pareja 41 .…”

“…Se asocia con una salud mental y física disminuida 40,42 . Según Mestre, existe una asociación entre disfunción sexual femenina y una pobre salud física, mental y un deterioro en la calidad de vida.…”