(118) Desire Beyond Cisgender Monogamy: Inclusivity Gaps in the Evidence Base for FDA Approved Meds for HSDD

Abstract Introduction Flibanserin and bremelanotide remain the only FDA-approved medications for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Despite widespread clinical interest in treating desire concerns across the lifespan and across diverse identities and relationship structures, pivotal trials for both medications enrolled exclusively cisgender, heterosexual, premenopausal women in long-term, stable, monogamous relationships, with required partnered sexual frequency. These eligibility restrictions raise critical questions about the generalizability and equity of the evidence base, particularly for perimenopausal and postmenopausal women, LGBTQ+ and gender-diverse populations, unpartnered or non-monogamous individuals, and those with desire concerns not tied to dyadic sexual activity. Objective 1. To characterize the demographics and relationship structures represented in clinical trials supporting flibanserin and bremelanotide. 2. To evaluate inclusivity relative to gender identity, sexual orientation, menopausal stage, sexual behavior assumptions, and partnership status. 3. To identify gaps limiting clinical applicability to real-world sexual medicine populations. 4. To propose a DEI-aligned research agenda consistent with ISSWSH priorities. Methods A narrative review was conducted using and major systematic reviews of flibanserin and bremelanotide trials. Inclusion/exclusion criteria, authors’ rationales, and generalizability statements were extracted. Trials were screened for inclusion/exclusion criteria, participant demographics, menopausal status, required relationship duration, sexual activity requirements, and any reporting of gender identity or sexual orientation. Results Across all trials, participants were overwhelmingly premenopausal cisgender women. Most studies required: • Long-term monogamous relationships (6-10 years) • Regular partnered sexual activity • Heterosexual dyads (explicitly in flibanserin trials; permitted but still monogamous in most bremelanotide trials) No trials explicitly included transgender, non-binary, or gender-expansive participants. Perimenopausal and postmenopausal individuals were systematically excluded. There was a single study with unclear methodology in regard to inclusion criteria for length of relationship and excluded non- monogamous relationships. Unpartnered, newly partnered, divorced, widowed, queer, or non-monogamous individuals were also excluded, despite well-documented prevalence of desire concerns across these groups. As a result, current FDA-approved pharmacotherapy is supported by evidence anchored in a narrow, cis-heteronormative relationship model, creating potential limitations for equitable clinical care and informed consent. Conclusions The evidence base for FDA-approved HSDD pharmacotherapy relies on highly restrictive demographic and relational criteria that exclude many populations experiencing desire concerns. This limits generalizability and may inadvertently reinforce a narrow conceptualization of sexual desire as occurring only within long-term, heterosexual, cisgender monogamous partnerships. Future research must intentionally include: • Perimenopausal and postmenopausal individuals • Sexual and gender minorities • Unpartnered and non-monogamous people • Diverse relationship structures and sexual behavior patterns Developing inclusive trial designs is critical to ensuring equitable access to evidence-based treatments and aligns with ISSWSH’s commitment to DEI, whole-person sexuality, and patient-centered care. Disclosure No.