5 completed. 5 Phase 1.
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All 5 trials
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 |
|---|
Bioequivalence Study: 3 mg Estradiol Valerate (EV) With and Without Levomefolate Calcium
Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078), Estradiol Valerate (EV) (BAY86-4980), Levomefolate Calcium (BAY86-7660) - Contraception, Ovulation Inhibition | Phase 1 | Completed | 42 | 2009-12-01 | 2014-02-20 |
Bioequivalence Study: 2 mg Estradiol Valerate (EV) and 3 mg Dienogest (DNG) Without and With Levomefolate Calcium
BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calcium, BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG), BAY 86-7660,levomefolate calcium - Pharmacology, Clinical | Phase 1 | Completed | 43 | 2009-09-01 | 2016-08-01 |
Assessment of the Pharmacodynamic Effect on Plasma Folate and Red Blood Cell Folate and Comparison of the Folate Metabolites During the 24 Weeks of Treatment (Yasmin + Metafolin Versus Yasmin + Folic Acid) Followed by a 20 Week Elimination Phase of Folate
EE 0.03 mg/DRSP 3 mg/Metafolin + folic acid placebo, EE 0.03 mg/DRSP 3 mg (Yasmin) + folic acid - Contraception | Phase 1 | Completed | 172 | 2006-12-01 | 2013-09-20 |
Investigation of Bioequivalence of Ethinylestradiol (EE) and Drospirenone (DRSP) in Two Different Tablet Formulations: YAZ and YAZ + Levomefolate Calcium (Metafolin) & L-5-MTHF in Two Different Tablet Formulations: Levomefolate Calcium (Metafolin) and YAZ + Levomefolate Calcium (Metafolin)
EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300), EE 0.02 mg/DRSP 3 mg/L-5-MTHF Ca 0.451 mg (EE20/DRSP/L-5-MTHF Ca), L-5-MTHF 0.451mg (Metafolin) - Contraception | Phase 1 | Completed | 44 | 2006-10-01 | 2013-08-07 |
Investigation of Bioequivalence of Ethinylestradiol (EE) and Drospirenone (DRSP) in Two Different Tablet Formulations: Yasmin and Yasmin + Levomefolate Calcium (Metafolin) & L-5-MTHF in Two Different Tablet Formulations: Levomefolate Calcium (Metafolin) and Yasmin + Levomefolate Calcium (Metafolin)
EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131), EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca), L-5-MTHF Ca 0.451 mg (Metafolin) - Contraception | Phase 1 | Completed | 48 | 2006-08-01 | 2013-08-07 |
Sponsors
Bayer (5)
Countries
Germany (4) · Netherlands (1)
Results publications
PMID 22067789, PMID 22909145, PMID 23610531
NIH funding
2005 (2), 2009 (2)