drugset / Trial / NCT07818720
MLS101 Study in PMDD
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The goal of this clinical trial is to learn if MLS101 (psilocybin) is a possible treatment for women with Premenstrual Dysphoric Disorder (PMDD). The main question it aims to answer is: • Test the safety and tolerability of the study drug, MLS101 in premenopausal women (ages 18-50 inclusive) with PMDD.
Timeline
- Start
- 2026-12
- Primary completion
- 2027-09
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Psilocybin | Other / unclassified | 2 mg | — |
| Comparator | Psilocybin | Other / unclassified | 4 mg | — |
| Comparator | Psilocybin | Other / unclassified | 8 mg | — |