Clinical Trial

A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD

Completed Phase 3
View on ClinicalTrials.gov →
Summary
The purpose of this research study is to test the study drug, LPCN 1154A, as a possible treatment for postpartum depression (PPD). The trial aims to determine: * If LPCN 1154A reduces depressive symptoms in subjects with severe PPD * How well LPCN 1154A is tolerated and what side effects it may cause * If LPCN 1154A reduces anxiety symptoms in subjects with severe PPD
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-05-13; most recent amendment 2026-02-20.
Status change: Recruiting → Completed 2026-02-20
Status change: Not Yet Recruiting → Recruiting 2025-06-18
Trial Details
NCT Number NCT06979544
Lead Sponsor Lipocine Inc.
Conditions Depression, Postpartum, Depression, Post-Partum, Postpartum Depression (PPD), Post-Natal Depression, Peripartum Depression, Postnatal Depression
Enrollment 90 participants
Start Date 2025-06-16
Primary Completion 2026-01-16 (estimated)
Study Completion 2026-02-17 (estimated)
Updated on ClinicalTrials.gov 2026-02-24