By Kristen Snipes, Director, Clinical Operations

Internet personality and women’s health advocate, Madge the Vag by Scary Mommy recently  shared two Instagram videos tackling hypoactive sexual desire disorder (HSDD), a bothersome decrease in the desire to engage in sexual activity affecting an estimated ten percent of women. The videos, launched in partnership with AMAG’s, highlight the impact of HSDD and offer tips for women as they prepare to speak with their healthcare provider. We’re excited to see an open dialogue around this often-taboo topic. 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.

Confusing Terms

First and foremost, it’s critical that women understand the difference between sexual desire and arousal.

Desire refers to baseline interest in sex (sexual appetite, libido). While it’s normal for libido to wax and wane, if lack of desire becomes distressing, a woman may be diagnosed with HSDD. Whereas, Arousal is the physiological response to sexual stimuli. Women who are unable to become aroused or maintain arousal during sexual activity may suffer from female sexual arousal disorder (FSAD).

The current classification system categorizes the two together as female sexual interest/arousal disorder (FSIAD) due to the significant overlap in clinical practice. When conducting clinical trials, approval is typically sought for either HSDD or FSAD. Researchers/investigators must clearly distinguish which disorder is the predominant condition.

Opening Up

Even when a woman recognizes that an issue exists, she may be unwilling to speak with a health care professional. According to Robin Kroll, MD, a Gynecologist at Seattle Women’s who specializes in the research and treatment of female sexual dysfunction, women are often hesitant to open up about issues related to sexuality. This makes it difficult for providers to collect the information needed to

diagnosis and treat a problem. Leading with general, open-ended questions followed by more specific questions can improve the patient-provider dialogue.

“The more a woman is willing to disclose to a healthcare provider, the more accurately the provider can assess the situation, offer a diagnosis and suggest a treatment plan,” says Dr. Kroll. “Because it’s such a delicate and complicated topic, gathering information from women about their sexual issues is an art form. We, as clinicians, need to be comfortable and open in our discussions with our patients and provide them with a safe space to communicate their concerns.”

Data Collection

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.

The Bottom Line

Research shows that the best outcomes are achieved when provider and patient work together to identify and address all relevant factors. Selecting sites that understand how to engage women in difficult conversations and are committed to showing trial participants they are a priority can go a long way in improving subject engagement/retention and data collection.

With the FDA prioritizing female sexual dysfunction as an area of high priority, we are hopeful that awareness of female sexual dysfunction continues to expand and research addressing currently unmet needs brings forth novel treatment options.

Read more about Health Decisions’ considerations for clinical trials in female sexual dysfunction here.