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

RECRUITINGPhase 3Sponsored by Lipocine Inc.
Actively Recruiting
PhasePhase 3
SponsorLipocine Inc.
Started2025-06-16
Est. completion2026-04
Eligibility
Age15 Years – 45 Years
SexFEMALE
Healthy vol.Accepted
Locations18 sites
View on ClinicalTrials.gov →

NCT06979544

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

Eligibility

Age: 15 Years – 45 YearsSex: FEMALEHealthy volunteers accepted
Key Inclusion Criteria:

* Are female between 15 and 45 years of age, inclusive;
* Have had a depressive episode that began no earlier than third trimester and later than the first 4 week following delivery
* Are \< 12 months postpartum at Screening
* Hamilton Depression Rating Scale (HAM-D) 17-item score indicative of severe depression

Key Exclusion Criteria:

* Have a history of bipolar disorder, schizophrenia or schizoaffective disorder
* Are currently experiencing active psychosis per Investigator assessment
* Have a history of suicidal behavior within 1 year
* Have a history of seizure within 6 months of Screening

Conditions7

DepressionDepression, Post-PartumDepression, PostpartumPeripartum DepressionPost-Natal DepressionPostnatal DepressionPostpartum Depression (PPD)

Locations18 sites

Advanced Research Center
Anahiem, California, 92805
Alliance Research Institute
Canoga Park, California, 91304
MedOne Clinical Research, LLC
Miami, Florida, 33145
D&H National Research Centers
Miami, Florida, 33155
Meridian International Research
Miami Gardens, Florida, 33014

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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