check_circleStudy Completed

Neural Tube Defects, Contraception, Oral Contraceptives (OC)

Bayer Identifier:

91523

ClinicalTrials.gov Identifier:

NCT00468481

EudraCT Number:

Not Available

EU CT Number:

Not Available
Efficacy and Safety Study for an Oral Contraceptive Containing Folate

Trial purpose

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

Key Participants Requirements

Sex

Female

Age

18 - 40 Years
  • - Healthy women between 18 and 40 requesting oral contraception
  • - The use of steroidal oral contraceptives, or any drug that could alter Oral Contraception metabolism will be prohibited during the study

Trial summary

Enrollment Goal
385
Trial Dates
April 2007 - September 2008
Phase
Phase 3
Could I Receive a placebo
No
Products
EE/DRSP/L-5-MTHF (BAY86-5131)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Orange County Clinical TrialsAnaheim, 92801, United States
Completed
Medical Center for Clinical ResearchSan Diego, 92108, United States
Completed
SNBL Clinical Pharmacology Center, Inc.Baltimore, 21201, United States
Completed
AAIPharma, Inc.Morrisville, 27560, United States
Completed
Coastal Carolina Research CenterMt. Pleasant, 29464, United States
Completed
NorthWest KineticsTacoma, 98418, United States
Completed
New Orleans Center for Clinical ResearchKnoxville, 37920, United States
Completed
Columbia University Medical CenterNew York, 10032, United States
Completed
Lyndhurst Gynecologic AssociatesWinston-Salem, 27103, United States

Primary Outcome

  • Red Blood Cell (RBC) Folate Level at 24 Weeks
    date_rangeTime Frame:
    Week 24
    enhanced_encryption
    Safety Issue:
    No
  • Plasma Folate Level at 24 Weeks
    date_rangeTime Frame:
    Week 24
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Mean Neural Tube Defect (NTD) Risk Reduction at Week 24
    date_rangeTime Frame:
    Baseline and week 24
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from baseline in red blood cell (RBC) folate levels at week 4
    date_rangeTime Frame:
    baseline and up to week 4
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from baseline in red blood cell (RBC) folate levels at week 8
    date_rangeTime Frame:
    baseline and up to week 8
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from baseline in red blood cell (RBC) folate levels at week 12
    date_rangeTime Frame:
    baseline and up to week 12
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from baseline in red blood cell (RBC) folate levels at week 16
    date_rangeTime Frame:
    baseline and up to week 16
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from baseline in red blood cell (RBC) folate levels at week 20
    date_rangeTime Frame:
    baseline and up to week 20
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from baseline in plasma folate levels at week 4
    date_rangeTime Frame:
    baseline and up to week 4
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from baseline in plasma folate levels at week 8
    date_rangeTime Frame:
    baseline and up to week 8
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from baseline in plasma folate levels at week 12
    date_rangeTime Frame:
    baseline and up to week 12
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from baseline in plasma folate levels at week 16
    date_rangeTime Frame:
    baseline and up to week 16
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from baseline in plasma folate levels at week 20
    date_rangeTime Frame:
    baseline and up to week 20
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from baseline in plasma homocysteine levels at week 4
    date_rangeTime Frame:
    baseline and up to week 4
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from baseline in plasma homocysteine levels at week 8
    date_rangeTime Frame:
    baseline and up to week 8
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from baseline in plasma homocysteine levels at week 12
    date_rangeTime Frame:
    baseline and up to week 12
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from baseline in plasma homocysteine levels at week 16
    date_rangeTime Frame:
    baseline and up to week 16
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from baseline in plasma homocysteine levels at week 20
    date_rangeTime Frame:
    baseline and up to week 20
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from baseline in plasma homocysteine levels at week 24
    date_rangeTime Frame:
    baseline and up to week 24
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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