A Study to Evaluate Folate Levels in Women Taking Oral Contraceptives
A Study to Evaluate Folate Levels in Women Taking Oral Contraceptives
The purpose of this study is to compare red blood cell folate levels in women who are taking
 oral contraceptives with or without folic acid
Studies have shown an association between increased folic acid (a synthetic form of folate, a
 B-vitamin) intake and reduction of a birth defect referred to as neural tube defects (NTDs).
 If women using contraception were to receive a combination of an oral contraceptive and folic
 acid, they may have the benefit of increased blood folate levels, which could reduce the risk
 of NTDs. This is a multi-center, double-blind study designed to study red blood cell folate
 levels in women who are taking oral contraceptives with or without folic acid. Patients will
 receive oral contraceptives with or without folic acid for 8 cycles of 28 days each. The
 study will consist of 2 parts of 4 cycles each. All patients will receive oral contraceptives
 throughout both parts of the study, patients may or may not receive folic acid in combination
 with the oral contraceptive during 1 or both parts of the study. The concentration of red
 blood cell folate will be determined by laboratory tests after Cycles 1, 2, 4, 5, 6 and 8.
 Safety evaluations (incidence of adverse events, electrocardiograms, physical examinations,
 laboratory tests) will be performed throughout the study. Patients may also participate in an
 optional portion of the study in which their genetic material is analyzed to see if contains
 something that would affect the way folic acid is used by their bodies. The study hypothesis
 is that women taking an oral contraceptive with folic acid will have increased levels of red
 blood cell folate compared to women taking an oral contraceptive without folic acid. Some
 women who receive the oral contraceptive with folic acid during the first four cycles will be
 transitioned to an oral contraceptive without folic acid for Cycles 5-8. In this group of
 women, the rate of decrease in red blood cell folate levels will be measured. Norgestimate
 250 micrograms (mcg)-ethinyl estradiol 35 mcg tablets, with or without folic acid 400 mcg, 2
 tablets taken by mouth daily between 6:00 a.m. and 10:00 a.m. for 8 cycles of 28 days
 duration each for a total of 224 days
Inclusion Criteria:

 -  Non-pregnant post menarcheal, premenopausal females who agree to use the assigned
 study medication as contraception during the study

 -  Non-vegan

 -  Non-smoker or no history of tobacco use within 6 months

 -  Willing to follow protocol-specific prohibitions and restrictions regarding diet,
 smoking and use of other medications

 Exclusion Criteria:

 -  Have taken multivitamins, folic-acid containing supplements, or highly fortified
 (i.e., >200 mcg folic acid/serving) cereals within 30 days of entry in to the study

 -  history or presence of blood clots in the veins, strokes or other blood clotting
 disorder, liver tumor from pervious contraceptive or estrogen use, disease of the
 blood vessels of the brain or heart disease, uncontrolled high blood pressure, cancer
 in any part of the body, diabetes mellitus with complications in the flow of blood in
 the body, jaundice, visual disturbance, liver disease, undiagnosed vaginal bleeding,
 gastric bypass surgery, ulcerative colitis or other digestive system disorders,
 abnormal thyroid function, Vitamin B 12 deficiency or very high red blood cell folate
 levels, alcohol or substance abuse, positive for drugs of abuse

 -  recent use of hormonal contraceptives

 -  on any weight reduction diet

 -  blood donation within 30 days of study entry