Female Sexual Dysfunction Challenges In Clinical Trials

By Kristen Snipes, Director, Clinical Operations

With only two FDA-approved HSDD therapies and treatment demand for female sexual dysfunction on the rise, we expect an increase in clinical research initiatives. Given the complex nature of feminine sexuality – not to mention the female reproductive system – many challenges can impact patient care.

Beyond standard patient-provider interactions, if a woman chooses to participate in a clinical trial, she will need help understanding the significance of the information shared during office visits and/or through eDiaries or other data collection platforms. When trial subjects recognize their value, data quality may improve – particularly in terms of self-reported outcomes.

The placebo effect has also created challenges in accurately capturing outcomes in trials investigating treatments for sexual desire. A sympathetic ear, structured interviews and follow-up questionnaires are powerful interventions. Sites need specific training to mitigate unwanted placebo effects.