A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD
← catalyst calendarSponsored by Lipocine Inc. (industry) · LPCN — their whole pipeline →.
Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
90actual
Sites
18
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-06-16 | actual | When the study began enrolling |
| Primary completion | 2026-01-16 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-02-17 | actual | The whole study's end, after follow-up |
| First posted | 2025-05-20 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-24 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Depression, Postpartum
- Depression, Post-Partum
- Postpartum Depression (PPD)
- Post-Natal Depression
- Peripartum Depression
- Postnatal Depression
Interventions
- Drug: LPCN 1154A — also filed as Brexanolone
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFChange from baseline in HAM-D17 total score compared to placebo
measured Baseline to Hour 60
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