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Drugs / levomefolate calcium
last change Feb 2015 re-read 2 minutes ago

levomefolate calcium

also known as Metafolin · folate · Levomefolate
Developed for
Angelman syndrome
Investigated by
Bayer · Baylor College of Medicine · Boston Children's Hospital · Greenwood Genetic Center · Rady Children's Hospital, San Diego · Rare Diseases Clinical Research Network
+1 more · University of California, San Diego

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) BEYAZ — 2010-09-24 fda.gov ↗

Trials 3 · a red edge is where a trial was stopped

today
US approved 2010
NCT01902264 · Ph 3 NCT01258660 · Ph 1 NCT00348933 · not/applicable
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
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
— NCT00348933 Jul 2006 → Feb 2010 Angelman syndrome University of California, San Diego Completed No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
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.

FieldValueCited 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 ↗
1

NCT00348933 ↗
Route Oral “Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive” NCT01360996 ↗