Trials / Completed
CompletedNCT06979544
A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD
A Randomized, Blinded, Placebo-Controlled Study to Evaluate the Saftey and Efficacy of Oral LPCN 1154A in Women With Postpartum Depression
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- Lipocine Inc. · Industry
- Sex
- Female
- Age
- 15 Years – 45 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | LPCN 1154A | Oral LPCN 1154A tablets for 48 hours |
| DRUG | Placebo | Oral Placebo Tablets for 48 hours |
Timeline
- Start date
- 2025-06-16
- Primary completion
- 2026-01-16
- Completion
- 2026-02-17
- First posted
- 2025-05-20
- Last updated
- 2026-02-24
Locations
18 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06979544. Inclusion in this directory is not an endorsement.