Designing clinical trials in women’s health comes with unique challenges and one of the most critical is selecting the right endpoint. Trials often stumble not because the intervention fails, but because the endpoint doesn’t capture meaningful outcomes.

Ask the Right Questions

When planning a study, start by evaluating your endpoints carefully:

• Is the endpoint clinically meaningful?

Will it reflect real improvements in patients’ health or quality of life?

• Is it patient-reported?

Women’s experiences, symptoms, and daily functioning matter just as much as lab results.

• Is it validated in women?

Tools developed for general populations may not translate accurately to female participants.

• Does it correlate with regulatory acceptance?

Choosing endpoints that regulators recognize can speed approvals and reduce trial risk.

Examples of Robust Endpoints

Here are some proven endpoints commonly used in women’s health research:

• Menstrual pain scales – Validated Visual Analogue Scales (VAS) provide a standardized way to measure pain intensity.

• Female Sexual Function Index (FSFI) – A comprehensive patient-reported measure for sexual function.

• Greene Climacteric Scale – Assesses menopausal symptoms including anxiety, depression, and somatic complaints.

• Vaginal pH & Nugent score – Objective measures for assessing vaginal health and microbiome status.

• Hormonal biomarkers – Levels of estradiol (E2), follicle-stimulating hormone (FSH), and luteinizing hormone (LH) provide physiological insights.

The Power of Combining Measures

For the most meaningful results, consider combining objective and patient-reported endpoints. This approach captures both the biological effect of your intervention and the lived experience of women, giving your trial a richer, more credible dataset.

Selecting the right endpoints isn’t just a checkbox in trial design, it’s the foundation for meaningful, actionable results that can truly impact women’s health.