NCT00468481

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
385

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

January 25, 2011

Completed
Last Updated

April 23, 2014

Status Verified

April 1, 2014

Enrollment Period

1.3 years

First QC Date

April 30, 2007

Results QC Date

January 4, 2011

Last Update Submit

April 4, 2014

Conditions

Neural Tube DefectsContraceptionOral Contraceptives (OC)

Keywords

Healthy women requesting contraceptionFolic Acid

Outcome Measures

Primary Outcomes (2)

  • Red Blood Cell (RBC) Folate Level at 24 Weeks

    RBC folate=(\[whole blood folate\*100\]-\[plasma folate\*(100-hematocrit)\])/hematocrit

    Week 24

  • Plasma Folate Level at 24 Weeks

    Folate concentrations in plasma were determined by an appropriately validated microbiological assay.

    Week 24

Secondary Outcomes (17)

  • Mean Neural Tube Defect (NTD) Risk Reduction at Week 24

    Baseline and week 24

  • Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 4

    baseline and up to week 4

  • Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 8

    baseline and up to week 8

  • Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 12

    baseline and up to week 12

  • Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 16

    baseline and up to week 16

  • +12 more secondary outcomes

Study Arms (2)

Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)

EXPERIMENTAL

1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks

Drug: Drospirenone/Ethinylestradiol/Methyltetrahydrofolate

Drospirenone (DRSP)/Ethinylestradiol (EE)

ACTIVE COMPARATOR

1 tablet 0.020 mg EE/3.0 mg DRSP \[YAZ\] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks

Drug: Drospirenone/Ethinylestradiol (Yaz)

Interventions

Drospirenone/Ethinylestradiol/MethyltetrahydrofolateDRUG

0.020 mg ethinylestradiol with 3.0 mg drospirenone and 0.451 mg L-5-methyltetrahydrofolate (L-5-MTHF)

Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)
Drospirenone/Ethinylestradiol (Yaz)DRUG

0.020 mg ethinylestradiol with 3.0 mg drospirenone

Drospirenone (DRSP)/Ethinylestradiol (EE)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Healthy women between 18 and 40 requesting oral contraception

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Orange County Clinical Trials

Anaheim, California, 92801, United States

Location

Medical Center for Clinical Research

San Diego, California, 92108, United States

Location

SNBL Clinical Pharmacology Center, Inc.

Baltimore, Maryland, 21201, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

AAIPharma, Inc.

Morrisville, North Carolina, 27560, United States

Location

Lyndhurst Gynecologic Associates

Winston-Salem, North Carolina, 27103, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

New Orleans Center for Clinical Research

Knoxville, Tennessee, 37920, United States

Location

NorthWest Kinetics

Tacoma, Washington, 98418, United States

Location

Related Publications (4)

  • 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.

    PMID: 22067790RESULT

  • 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.

    PMID: 23534865RESULT

  • 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.

    PMID: 21903192RESULT

  • 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.

    PMID: 24105751RESULT

MeSH Terms

Conditions

Neural Tube Defects

Interventions

drospirenoneEthinyl Estradioldrospirenone and ethinyl estradiol combination

Condition Hierarchy (Ancestors)

Nervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

NorpregnatrienesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Therapeutic Area Head
Organization
BAYER
clinical-trials-contact@bayerhealthcare.com

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2007

First Posted

May 2, 2007

Study Start

April 1, 2007

Primary Completion

August 1, 2008

Study Completion

September 1, 2008

Last Updated

April 23, 2014

Results First Posted

January 25, 2011

Record last verified: 2014-04

Locations

US(9)