OBJECTIVES: Endometriosis is an under reported disease, of unknown etiology. While endometriosis is actively being studied, barriers prevent participation in clinical trial research. Our previous work showed that endometriosis patients can provide meaningful and significant input on trial design leading to important and impactful adjustments, improvements to the study, and reduced participation barriers. This study characterized the US adult endometriosis population on disease burden and willingness to participate in clinical studies.

METHODS: We analyzed data from 2022 US National Health and Wellness Survey (NHWS), a self-administered, nationally-representative, cross-sectional online survey. Women (aged 18-50) never experienced endometriosis (n=13,693) were compared to those diagnosed with endometriosis (n=410); diagnosed medication users (UseRx, n=139) were compared to nonmedication users (NoRx, n=271). Peri/menopausal women were excluded. Variables included sociodemographic and health characteristics, PAM, GAD-7, PHQ-9, RAND-36, past 6-month HCRU, and attitudes towards clinical trials.

RESULTS: Endometriosis patients were White (59.8%), Hispanic (21.0%), African American (9.0%), college educated (45.6%), and insured (88.8%); 41.0% saw a gynecologist in the past six months. Diagnosed patients scored lower (worse) in all RAND-36 domains compared to those without endometriosis, higher rate of score 5+ on PHQ-9 and GAD-7 (PHQ-9: 72.9% vs 60.6%; GAD-7:69.8% vs 59.4%) and tended to lack reliable transportation (22.9% vs 16.5%). UseRx reported greater severe severity of the disease (69.1% vs 24.4%), fewer indicated PAM level 4 and higher HCRU (ER visits: 36.7% vs 26.9%; Hospitalized: 23.7% vs 14.4%) compared to NoRx. Despite burden, almost half (48.8%) of endometriosis patients were willing to participate in a clinical trial, with UseRx more willing than NoRx (51.1% vs. 47.6%).

CONCLUSIONS: Women with high endometriosis disease burden are willing to participate in clinical trials. Clinical trial designers should consider the voiced needs of these patients, acknowledging depression, anxiety, lack of reliable transportation, lower activation in managing their health, and willingness to discontinue current medication.