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120 Participants NeededMy employer runs this trial

LPCN 1154A for Postpartum Depression

(BLOOM Trial)

Recruiting at 15 trial locations
VP
Overseen ByVice President of Clinical Development
Age: < 65
Sex: Female
Trial Phase: Phase 3
Sponsor: Lipocine Inc.
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

This trial is for women who have recently given birth and are experiencing severe postpartum depression. Participants must meet certain health requirements, but specific inclusion or exclusion details were not provided.

Inclusion Criteria

I am a female between 15 and 45 years old.
Are less than 18 months postpartum at Screening
Hamilton Depression Rating Scale (HAM-D) 17-item score indicative of severe depression
See 1 more

Exclusion Criteria

I have had a seizure in the past six months.
Have a history of bipolar disorder, schizophrenia or schizoaffective disorder
Are currently experiencing active psychosis per Investigator assessment
See 1 more

What Are the Treatments Tested in This Trial?

Interventions

  • LPCN 1154A

Trial Overview

The study is testing a new drug called LPCN 1154A to see if it helps reduce symptoms of postpartum depression compared to a placebo (inactive treatment). Participants are randomly assigned to receive either the drug or placebo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: LPCN 1154A TabletsExperimental Treatment1 Intervention
Group II: Placebo TabletsPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lipocine Inc.

Lead Sponsor

Trials
7
Recruited
760+

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