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

NCT06979544 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-02-24

No results posted yet for this study

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

Conditions

  • Depression, Postpartum
  • Depression, Post-Partum
  • Postpartum Depression (PPD)
  • Post-Natal Depression
  • Peripartum Depression
  • Postnatal Depression

Interventions

DRUG

LPCN 1154A

Oral LPCN 1154A tablets for 48 hours

DRUG

Placebo

Oral Placebo Tablets for 48 hours

Sponsors & Collaborators

  • Lipocine Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-16
Primary Completion
2026-01-16
Completion
2026-02-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06979544 on ClinicalTrials.gov