Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06979544 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD
A Phase 3 study, sponsored by Lipocine.
- Completed
- Registry status
- Phase 3
- Development phase
- 90
- Enrollment target
NCT06979544: Completed Phase 3 study, sponsored by Lipocine.
NCT06979544 is a Phase 3 study that has completed, run by Lipocine. The registered enrollment target is 90 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06979544, a Phase 3 study, has completed, sponsored by Lipocine.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 90 participants
- Enrollment target
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
Primary Outcome
The Seventeen-Item Hamilton Rating Scale for Depression (HAM-D17) contains 17 individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia (initial, middle, and late), work and interests, psychomotor retardation, psychomotor agitation, anxiety (psychic and somatic), gastrointestinal symptoms, general somatic symptoms, sexual interest, hypochondriasis, insight, and weight loss. The total score ranges from 0 to 52, with higher scores indicating more se
Interventions
- DRUG Placebo
- DRUG LPCN 1154A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2025-06-16 |
| Est. Completion | 2026-02-17 |
| Phase | Phase 3 |
What the finished NCT06979544 record still lists
NCT06979544 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06979544 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06979544 about?
NCT06979544 is a clinical study titled "A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD". 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 cau...
What is the current status of trial NCT06979544?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 90 participants. The study started on 2025-06-16. Estimated completion is 2026-02-17.
What interventions are being tested in trial NCT06979544?
The interventions under investigation include: Placebo (DRUG), LPCN 1154A (DRUG).
Who is sponsoring clinical trial NCT06979544?
This trial is sponsored by Lipocine, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06979544's enrollment target sits among peer trials
90 1724th of 2000 higher than 263 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02521311 · 90 participants · Phase 2
Assessment of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis (ReCOVER)
- NCT02939573 · 90 participants · Phase 2
A Randomized Multicenter Study for Isolated Skin Vasculitis
- NCT03128879 · 90 participants · Phase 2
Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL
- NCT03184038 · 90 participants · NA
Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI