| Dimension | Scoring Notes | Score |
|---|---|---|
| Study Design | Multiple Phase III RCTs for hypoactive sexual desire disorder (HSDD) in premenopausal women. FDA approved (Vyleesi, 2019). Well-designed regulatory trials. |
20 / 25 |
| Sample Size | RECONNECT trial enrolled 1,247 women — reasonably large. But single primary indication (HSDD in women); male sexual dysfunction data is smaller Phase II. |
16 / 20 |
| Replication | Replicated across multiple RECONNECT trial sites globally. Male sexual function studies replicated in smaller independent trials. Core melanocortin MC4R mechanism well replicated. |
15 / 20 |
| Journal Impact Factor | Published in Journal of Sexual Medicine (IF ~3.5) and obstetrics/gynecology journals. Specialty journals appropriate for the indication. |
8 / 15 |
| Funding Independence | Palatin Technologies (developer) funded primary trials. Pre-registered and FDA-reviewed but entirely industry funded for primary indication. |
4 / 10 |
| Population Diversity | RECONNECT enrolled diverse premenopausal women across age, ethnicity, and relationship status. |
3 / 5 |
| Researcher h-Index | James Simon (GWU) and other women's health investigators have h-Indexes 30+. Credible clinical investigators. |
3 / 5 |