Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00301587
Status:
WITHDRAWN
Last Update Posted:
2016-09-20
First Post:
2006-03-10
Brief Title:
A Study to Evaluate Folate Levels in Women Taking Oral Contraceptives
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Double-Blind Two-Part Parallel-Group Comparative Study to Evaluate Blood Folate Levels in Women Taking an Oral Contraceptive With and Without Folic Acid
Status:
WITHDRAWN
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company decision to not fund further development of womens health new drug development programs
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 600 am and 1000 am for 8 cycles of 28 days duration each for a total of 224 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None