8 completed, 1 recruiting. 6 Phase 3, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 6 | Completed 5, Recruiting 1 |
| Phase 2 | 3 | Completed 3 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Brexanolone Lifting Outcomes Of Moms LPCN 1154A, Placebo - Depression, Postpartum, Postpartum Depression (PPD) | Phase 3 | Recruiting | Lipocine Inc. | 120 | 2026-09-01 | 2026-09-16 |
| A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD LPCN 1154A, Placebo - Depression, Postpartum, Depression, Post-Partum | Phase 3 | Completed | Lipocine Inc. | 90 | 2025-06-16 | 2026-02-24 |
| A Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia LPCN 1148, Placebo - Liver Cirrhosis, Sarcopenia | Phase 2 | Completed | Lipocine Inc. | 30 | 2021-11-30 | 2024-03-15 |
| A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial LPCN 1144 - NASH - Nonalcoholic Steatohepatitis | Phase 2 | Completed | Lipocine Inc. | 25 | 2020-11-11 | 2024-07-17 |
| The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis LPCN 1144 Formulation A, LPCN 1144 Formulation B, Placebo - Nonalcoholic Steatohepatitis (NASH) | Phase 2 | Completed | Lipocine Inc. | 56 | 2019-08-27 | 2023-12-14 |
| Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men LPCN 1021 - Hypogonadism, Male | Phase 3 | Completed | Lipocine Inc. | 138 | 2018-04-30 | 2021-06-10 |
| Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021) LPCN 1021 - Hypogonadism, Male | Phase 3 | Completed | Lipocine Inc. | 100 | 2017-01-01 | 2019-10-23 |
| Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021). LPCN 1021 - Hypogonadism, Male | Phase 3 | Completed | Lipocine Inc. | 95 | 2016-12-01 | 2019-10-23 |
| Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism Oral testosterone undecanoate, LPCN 1021, Topical testosterone gel 1.62 % - Male Hypogonadism | Phase 3 | Completed | Lipocine Inc. | 315 | 2014-02-01 | 2017-10-23 |
Eunuchism (4) · Depression, Postpartum (2) · Non-alcoholic Fatty Liver Disease (2) · Depression (1) · Endocrine System Diseases (1) · Gonadal Disorders (1) · Hypogonadism (1) · Liver Cirrhosis (1) · Sarcopenia (1)
Testosterone Propionate (4) · testosterone undecanoate (3) · brexanolone (2) · alpha-Tocopherol (1)
United States (6)
Anthony DelConte, MD (3) · Anthony DelConte (2) · Anthony Delconte, MD (1)