drugset / Trial / NCT00468481
Efficacy and Safety Study for an Oral Contraceptive Containing Folate
RandomizedParallel-groupDouble-blindPrevention
Summary
The purpose of this study is to determine whether the study drug is safe and effective
Timeline
- Start
- 2007-04
- Primary completion
- 2008-08
- Completion
- 2008-09
Outcome
Met primary endpoint
registry analysis (superiority or other test); Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) vs Drospirenone (DRSP)/Ethinylestradiol (EE); p <0.0001; Mean Difference (Final Values) 384.70 (95% CI 282.42 to 486.98); ANCOVA NCT00468481 ↗
registry analysis (superiority or other test); Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) vs Drospirenone (DRSP)/Ethinylestradiol (EE); p <0.0001; Mean Difference (Final Values) 18.87 (95% CI 14.04 to 23.70); ANCOVA NCT00468481 ↗
Publications
- Results Bart S Sr, Marr J, Diefenbach K, Trummer D, Sampson-Landers C. Folate status and homocysteine levels during a 24-week oral administration of a folate-containing oral contraceptive: a randomized, double-blind, active-controlled, parallel-group, US-based multicenter study. Contraception. 2012 Jan;85(1):42-50. doi: 10.1016/j.contraception.2011.05.013. Epub 2011 Jul 13.
- Results Castano PM, Aydemir A, Sampson-Landers C, Lynen R. The folate status of reproductive-aged women in a randomised trial of a folate-fortified oral contraceptive: dietary and blood assessments. Public Health Nutr. 2014 Jun;17(6):1375-83. doi: 10.1017/S1368980013000864. Epub 2013 Mar 27.
- Results Taylor TN, Farkouh RA, Graham JB, Colligs A, Lindemann M, Lynen R, Candrilli SD. Potential reduction in neural tube defects associated with use of Metafolin-fortified oral contraceptives in the United States. Am J Obstet Gynecol. 2011 Nov;205(5):460.e1-8. doi: 10.1016/j.ajog.2011.06.048. Epub 2011 Jun 21.
- Results Campone M, Berton-Rigaud D, Joly-Lobbedez F, Baurain JF, Rolland F, Stenzl A, Fabbro M, van Dijk M, Pinkert J, Schmelter T, de Bont N, Pautier P. A double-blind, randomized phase II study to evaluate the safety and efficacy of acetyl-L-carnitine in the prevention of sagopilone-induced peripheral neuropathy. Oncologist. 2013;18(11):1190-1. doi: 10.1634/theoncologist.2013-0061. Epub 2013 Oct 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | L-5-methyltetrahydrofolate | Unknown | 0.451 mg | Oral |
| Comparator | drospirenone | Unknown | 3 mg | Oral |
| Comparator | ethinyl estradiol | Small molecule | 0.02 mg | Oral |