Shifting Priorities in Women’s Health: 6 Trends to Watch in Clinical Research

Women’s health has historically been underrepresented in clinical research, often limited to reproductive endpoints and underfunded across key therapeutic areas. But that landscape is beginning to shift—albeit gradually—as a broader definition of women’s health takes hold, and new avenues for innovation emerge. 

From improved diagnostics for endometriosis to novel contraceptive technologies and the growing visibility of conditions like Female Sexual Interest/Arousal Disorder (FSIAD) and Premenstrual Dysphoric Disorder (PMDD), a more nuanced, lifecycle-based approach is informing both product development and trial design. At the same time, trends such as male contraception, vaginal microbiome research, and digital health integration are opening doors to more inclusive studies,  informing on sex-defined data and associated health outcomes. 

For sponsors and research partners, these developments present timely opportunities—but also require a thoughtful approach to protocol design, patient engagement, and therapeutic expertise. In this blog, we explore six of the most promising and high-impact trends shaping the current women’s health research landscape. 

1. Renewed focus on endometriosis, adenomyosis, and fibroids 

Conditions like endometriosis, adenomyosis, and uterine fibroids have long posed challenges in both diagnosis and treatment. Today, they’re drawing renewed attention across the research community—not only because of their impact on fertility and quality of life, but also due to advances in biomarker discovery, imaging, and minimally invasive therapies. Biomarkers under investigation for the early detection of endometriosis include inflammatory and immune markers, angiogenic and growth factors, microRNAs, and proteomic signatures. In addition to biomarker discovery, novel modalities such as remote monitoring of physiologic data and AI-directed, robotic-assisted non-invasive imaging are also in development. Smart menstrual cups equipped with diagnostic sensors—capable of transmitting data on flow, frequency, and regularity via a connected app—may enable early detection of gynecologic disorders such as adenomyosis and leiomyomata and potentially aid in identifying early-stage cancers. 

For sponsors, this signals a need for better-designed trials that can address heterogeneity in presentation, endpoints beyond pain reduction, and broader inclusion of diverse populations often affected by diagnostic delay. 

2. Broadening the scope of contraceptive development 

Contraceptive research and development is expanding beyond female-targeted methods to include male contraception, with early and late-stage clinical products exploring both hormonal and non-hormonal, fully reversible, high efficacy approaches. These developments, while still emerging, reflect an evolving public and regulatory appetite for shared responsibility in family planning, some of which is profiled in a new documentary, “It’s Different for Girls.” The film also highlights a male contraceptive gel with Phase 3 planning underway, including regulatory expectation discussions with FDA.  

For women, long-acting, reversible, hormonal and non-hormonal vaginal rings are showing tremendous promise. IUDs have typically shown excellent compliance, but barriers include unacceptable discomfort with insertion, risk of perforation, and partner discomfort. Frameless IUDs are being developed with improved tolerability and use-case flexibility in mind. These devices, both copper-and levonorgestrel-containing, may decrease pain with insertion, be more tolerable to women with a smaller uterine cavity, and be better tolerated by partners if stringless. IUDs are also being investigated for non-contraceptive indications, such as dysmenorrhea and endometriosis, opening new avenues for label expansion. Lastly, non-hormonal IUDs containing NSAIDs are showing promise for treatment of dysmenorrhea and will offer an attractive option for women not seeking contraception. 

3. A growing focus on female sexual health 

Traditionally overlooked in both medical training and product development, female sexual health is beginning to attract more serious clinical attention. Conditions like FSIAD are now part of the investigational landscape, with novel therapies (e.g., topical testosterone, neuromodulation devices) moving through early-phase studies. 

Designing trials in this space requires careful attention to patient-reported outcomes, psychosocial context, and multi-dimensional endpoints—underscoring the need for thoughtful protocol development and patient engagement strategies. 

4. Innovation in vaginal microbiome diagnostics 

The vaginal microbiome has emerged as a critical area of interest, particularly in its links to infection risk, infertility, and pregnancy outcomes. With new diagnostics entering the market, there is growing potential for microbiome-informed stratification in clinical trials and the development of microbiome-modulating therapies. 

Startups are actively developing tools that combine genomic sequencing with AI to map the vaginal ecosystem and identify at-risk individuals. For example, emerging diagnostics aim to differentiate between bacterial vaginosis and other causes of dysbiosis with high specificity, reducing misdiagnosis and unnecessary antibiotic use. In clinical research, these tools may soon allow stratification of participants by microbiome profile or even act as companion diagnostics in therapeutics development, which in turn holds promise for improving successful embryo transfer rates. 

5. Reframing women’s health across the lifespan 

A growing movement is reframing women’s health through a lifespan lens—one that extends beyond reproductive care. Conditions such as cardiovascular disease, Alzheimer’s, and autoimmune disorders affect women differently—and often disproportionately—yet remain underrepresented in clinical research. This mismatch has significant consequences: the top five causes of death for women in the U.S. are heart disease, stroke, chronic lower respiratory disease (COPD), Alzheimer’s disease, and cancer (primarily breast, lung, and colorectal). Most of these fall outside the traditional scope of women’s health, underscoring the urgency of a more inclusive, evidence-driven approach. 

Advocates are calling for broader definitions of women’s health: any condition that affects women solely, differently, or disproportionately, head to toe, throughout the lifespan. While progress is incremental, reframing is starting to influence funding priorities and research agendas. 

6. Policy momentum and the push for investment 

Policy is also beginning to align more closely with scientific progress. Recently, the first-ever Congressional Briefing on Women’s Health brought together more than 80 stakeholders who emphasized the importance of sustained investment in women’s health research and advocated for an additional $200 million in NIH funding to support studies focused on gender-specific outcomes and sex-based differences in disease. Enthusiasm for innovation is growing, and continued collaboration between policymakers, investors, and the research community will produce long-term impact. 

For industry stakeholders, this emerging policy focus reinforces the opportunity—and responsibility—to design studies that more fully capture the diversity of women’s experiences and ensure broader representation across age, race, ethnicity, and pre-existing health conditions. 

Looking ahead 

While progress in women’s health continues to face barriers—particularly in funding, representation, and regulatory alignment—the field is expanding in both scientific scope and commercial interest. For biopharma companies and research partners, this presents an opportunity to develop smarter, more inclusive studies that meet a growing demand for solutions tailored to women’s health needs. 

At Premier, we’re tracking these developments closely and supporting sponsors by providing the expertise and infrastructure needed to navigate this evolving landscape—from protocol design and site selection to patient engagement and data strategy. Our experience spans therapeutic areas and trial designs, allowing us to support emerging biotech and global pharma alike in bringing evidence-based women’s health innovations to market faster and more efficiently. 

As progress accelerates, collaboration across disciplines will be key to unlocking the next phase of innovation in women’s health. Contact us to learn more. 

ABOUT PREMIER RESEARCH:  

Premier Research, a global clinical research, product development, and consulting company, is dedicated to helping innovators transform life-changing ideas and breakthrough science into new medical treatments. We offer strategic solutions across the entire development lifecycle, from pre-clinical through commercialization, specializing in smart study design and full-service clinical trial management.    

Leveraging technology and therapeutic expertise, we deliver clean, conclusive data with a focus on reducing development timelines, securing access to the right patients, and effectively navigating global regulations to ensure submission-ready results.    

As an organization that puts patients first, we pride ourselves on helping customers answer the unmet needs of patients across a broad range of medical conditions. Visit premier-research.com.