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

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

Timeline

Start

2025-06-16

Primary completion

2026-01-16

Completion

2026-02-17

Outcome

Missed primary endpoint

release “In the Phase 3 study population (N=90) of patients with PPD, LPCN 1154 did not show a statistically significant reduction from baseline in HAM-D17 total score” lipocine.com ↗

release “the primary endpoint was not met” lipocine.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	LPCN 1154A	Unknown	—	Oral

Indications