A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD
NCT ID: NCT06979544
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
80 participants
INTERVENTIONAL
2025-06-16
2026-05-31
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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LPCN 1154A Tablets
LPCN 1154A
LPCN 1154A
Oral LPCN 1154A tablets for 48 hours
Placebo Tablets
Placebo Tablets
Placebo
Oral Placebo Tablets for 48 hours
Interventions
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LPCN 1154A
Oral LPCN 1154A tablets for 48 hours
Placebo
Oral Placebo Tablets for 48 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
15 Years
45 Years
FEMALE
No
Sponsors
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Lipocine Inc.
INDUSTRY
Responsible Party
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Locations
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Advanced Research Center
Anahiem, California, United States
Alliance Research Institute
Canoga Park, California, United States
MedOne Clinical Research, LLC
Miami, Florida, United States
D&H National Research Centers
Miami, Florida, United States
Meridian International Research
Miami Gardens, Florida, United States
Atlanta Behavioral Research
Atlanta, Georgia, United States
CenExel Research Center
Decatur, Georgia, United States
CenExel Research Center
Savannah, Georgia, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Cypress Medical Research Center, LLC
Kansas City, Kansas, United States
Best Clinical Trials
New Orleans, Louisiana, United States
Oasis Clinical Research
Las Vegas, Nevada, United States
Monroe Biomedical Research
Monroe, North Carolina, United States
Suburban Research Associates
Media, Pennsylvania, United States
Gadolin Research
Beaumont, Texas, United States
New Dawn Wellness and Medical Center
Houston, Texas, United States
Maximos OB/GYN
League City, Texas, United States
Populace Research
Provo, Utah, United States
Countries
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Central Contacts
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Other Identifiers
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LPCN 1154-24-002a
Identifier Type: -
Identifier Source: org_study_id
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