Lipocine Inc. (the Sponsor of this study) has developed a new oral (taken by mouth) formulation
of brexanolone. Progesterone, a hormone that is needed for normal growth and development, is metabolized (broken down) into many other compounds, including what are known as “neurosteroids.” One of these neurosteroid compounds is allopregnanolone, which is also called brexanolone when it
is administered as a drug. Brexanolone was approved as an intravenous (IV) injectable by the
Food and Drug Administration (FDA) to treat postpartum depression in 2019. Even though the
injectable brexanolone was effective in rapidly treating postpartum depression, it is no longer
available as of January 2025.
This is a research study to test a new investigational drug, LPCN 1154A, brexanolone.
The study is being conducted to test how LPCN 1154A affects women with postpartum
depression. The study drug LPCN 1 154A contains brexanolone identical to the allopregnanolone
your body makes.
The goals of this research study are to assess:
- How well LPCN 1154A treats postpartum depression (by monitoring depression
symptoms before, during, and after taking the study drug) - The safety of the study drug
- How you feel (tolerability) while on the study drug
You may qualify for this study if you:
Are 18 to 45 years old
Have a major depressive episode that began no earlier than the third trimester (26 weeks) and no later than 4 weeks postpartum
Are less than 12 months postpartum
Being part of this clinical trial is voluntary.
Eligible participants will receive all study-related care, procedures and medication at no cost. In addition, eligible participants may receive compensation for time and travel. No health insurance is required to participate.
For more information about this study, please call (316) 425-6333.