Phase 1
Completed N=172
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
Source: ClinicalTrials.gov NCT01258660 ↗Enrolled (actual)
172
Serious AEs
5.2%
Results posted
May 2011
Primary outcomePrimary: Area Under the Curve (AUC) From Time 0 to 24 Weeks [AUC(0-24weeks)] for Plasma Folate and RBC (Red Blood Cell) Folate (Baseline Uncorrected) — 1030; 904; 24176; 21876 nmol·week/L
Summary
The purpose of this study is to examine and compare the uptake of levomefolate calcium (Metafolin, a registered vitamin supplement) and folic acid in the body during 24 weeks of treatment with a following folate elimination phase of 20 weeks in healthy volunteers seeking contraception. Yasmin (oral contraceptive containing drospirenone and ethinylestradiol) was co-administered over the entire period of 44 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (AUC) From Time 0 to 24 Weeks [AUC(0-24weeks)] for Plasma Folate and RBC (Red Blood Cell) Folate (Baseline Uncorrected) |
1030; 904; 24176; 21876 | — |
| PRIMARY Area Under the Curve From Time 0 to 24 Weeks [AUC(0-24weeks)] for Plasma Folate and RBC (Red Blood Cell) Folate (Baseline Corrected) |
640; 561; 10427; 8863 | — |
| PRIMARY Proportion of Participants With RBC Folate Below 906 Nmol/L in the Yasmin + Metafolin Group in the Folate Elimination Phase (Week 24 to 44) |
0.053; 0.067; 0.147; 0.213; 0.400; 0.533 | — |
| SECONDARY Folate Metabolite Pattern in Plasma at Baseline |
4.07; 4.60; 1.57; 1.63 | — |
| SECONDARY Folate Metabolite Pattern in Plasma at Cycle 3 |
4.98; 5.28; 1.76; 1.45 | — |
| SECONDARY Folate Metabolite Pattern in Plasma at Cycle 6 |
5.92; 5.76; 1.46; 1.95 | — |
| SECONDARY Homocysteine Concentrations in Plasma at Baseline and at the End of Treatment (Week 24) With Metafolin |
9.3; 7.5 | — |
| SECONDARY Homocysteine Concentrations in Plasma at Baseline and at the End of Treatment (Week 24) With Folic Acid |
9.2; 7.6 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18-40 years.
- RBC folate > 317 nmol/L and 100 μg folic acid/day in vitamin supplements or fortified food during the last 4 months.
- Treatment with the following medications, which has the potential of interfering with folate metabolism: cholestyramine, methotrexate, trimethoprim, sulfasalazine, salicylic acid, cotrimoxazol, antacids or antiepileptic drugs.
- Pregnancy, lactation (at least three cycles have to follow delivery, abortion, or lactation before start of treatment)
- Vascular or metabolic disease including existing or previous arterial thromboembolic diseases (myocardial infarction, stroke), existing or previous venous thromboembolic diseases (deep vein thrombosis, pulmonary embolism), and any condition which could increase the risk to suffer any of the above mentioned disorders
- Any disease or condition that could compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication.
- Any disease that may worsen under hormonal treatment or might interfere with the conduct of the study or the interpretation of the results (e.g., herpes gestationis or idiopathic icterus pregnancy; middle-ear deafness ; Sydenham's chorea, porphyria, disturbances in the bile flow.
- Liver diseases: Presence or history of severe hepatic diseases including benign or malignant tumors
Data sourced from ClinicalTrials.gov (NCT01258660). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.