Clinical trial NCT00468481: Efficacy and Safety Study for an Oral Contraceptive Containing Folate
Official title: Multi-Center, Randomized, Double-Blind Active-Controlled, Parallel Group Study to Investigate Plasma Folate, Red Blood Cell Folate and Homocysteine Levels During a 24 Week Oral Administration of an OC Containing Folate Compared to OC Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neural Tube Defects
Contraception
Oral Contraceptives (OC)
Keywords: Healthy women requesting contraception
Folic Acid
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-05-02
Enrollment: 385
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the study drug is safe and effective

Detailed description: Acronym is used in result section: suspected/diagnosed (susp/diag)

Eligibility criteria: Inclusion Criteria:

- Healthy women between 18 and 40 requesting oral contraception

Exclusion Criteria:

- The use of steroidal oral contraceptives, or any drug that could alter Oral Contraception metabolism will be prohibited during the study

Primary outcomes:
measure: Red Blood Cell (RBC) Folate Level at 24 Weeks
timeFrame: Week 24
measure: Plasma Folate Level at 24 Weeks
timeFrame: Week 24
Secondary outcomes:
measure: Mean Neural Tube Defect (NTD) Risk Reduction at Week 24
timeFrame: Baseline and week 24
measure: Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 4
timeFrame: baseline and up to week 4
measure: Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 8
timeFrame: baseline and up to week 8
measure: Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 12
timeFrame: baseline and up to week 12
measure: Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 16
timeFrame: baseline and up to week 16
measure: Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 20
timeFrame: baseline and up to week 20
measure: Mean Change From Baseline in Plasma Folate Levels at Week 4
timeFrame: baseline and up to week 4
measure: Mean Change From Baseline in Plasma Folate Levels at Week 8
timeFrame: baseline and up to week 8
measure: Mean Change From Baseline in Plasma Folate Levels at Week 12
timeFrame: baseline and up to week 12
measure: Mean Change From Baseline in Plasma Folate Levels at Week 16
timeFrame: baseline and up to week 16
measure: Mean Change From Baseline in Plasma Folate Levels at Week 20
timeFrame: baseline and up to week 20
measure: Mean Change From Baseline in Plasma Homocysteine Levels at Week 4
timeFrame: baseline and up to week 4
measure: Mean Change From Baseline in Plasma Homocysteine Levels at Week 8
timeFrame: baseline and up to week 8
measure: Mean Change From Baseline in Plasma Homocysteine Levels at Week 12
timeFrame: baseline and up to week 12
measure: Mean Change From Baseline in Plasma Homocysteine Levels at Week 16
timeFrame: baseline and up to week 16
measure: Mean Change From Baseline in Plasma Homocysteine Levels at Week 20
timeFrame: baseline and up to week 20
measure: Mean Change From Baseline in Plasma Homocysteine Levels at Week 24
timeFrame: baseline and up to week 24
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Orange County Clinical Trials
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: Baltimore
country: United States
facility: SNBL Clinical Pharmacology Center, Inc.
state: Maryland
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Morrisville
country: United States
facility: AAIPharma, Inc.
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Gynecologic Associates
state: North Carolina
city: Mt. Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Knoxville
country: United States
facility: New Orleans Center for Clinical Research
state: Tennessee
city: Tacoma
country: United States
facility: NorthWest Kinetics
state: Washington
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.