A Phase 3 interventional study of Norgestimate-ethinyl estradiol, with or without folic acid in Neural Tube Defects, Congenital, Hereditary, and Neonatal Diseases and Abnormalities and Nervous System Malformations, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Withdrawn. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-20.
Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment
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
52 studies on the registry are indexed under Neural Tube Defects; 11 are open to participants now.
Browse Neural Tube Defects studies →Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 465 studies on the registry; none are open to participants now.
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Part 1: Change in concentration of folate in red blood cells (RBC) from the start of the study to Cycle 4 (4 cycles of 28 days of treatment)
Change in plasma folate concentration from baseline to Cycle 4; Levels and change from baseline in RBC and plasma folate concentration at specified time points during the study including Cycles 1, 2, 4, 5, 6, 8
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This study is withdrawn, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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