Drugs / levomefolate calcium
levomefolate calcium
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | BEYAZ | — | 2010-09-24 | fda.gov ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01258660 | Dec 2006 → Jan 2008 | — | Bayer | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT01902264 | Aug 2013 → Feb 2015 | — | Bayer | Completed | No outcome recorded |
| Phase not applicable1 trial · 1 missed | ||||||
| — | NCT00348933 | Jul 2006 → Feb 2010 | Angelman syndrome | University of California, San Diego | Completed | Missed primary |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT01360996 Background | Aug 2011 → Feb 2015 | polycystic ovary syndrome | Woman's | Completed | No outcome recorded |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | levomefolate calcium | “1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium...” NCT01360996 ↗1“levomefolate calcium (Metafolin, a registered vitamin supplement)” NCT01258660 ↗ |
| Known as | folate | “1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium...” NCT01360996 ↗ |
| Known as | Levomefolate | “Study of Treatment With the Combination of Drospirenone Plus Ethinyl Estradiol Plus Levomefolate Calcium in Mexican Women Seeking Contraception” NCT01902264 ↗ |
| Known as | Metafolin | “levomefolate calcium (Metafolin, a registered vitamin supplement)” NCT01258660 ↗ |
| Route | Oral | “Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive” NCT01360996 ↗ |