Efficacy and Safety Study for an Oral Contraceptive Containing Folate
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neural Tube Defects; Contraception; Oral Contraceptives (OC)
Intervention: Drospirenone/Ethinylestradiol/Methyltetrahydrofolate (Drug); Drospirenone/Ethinylestradiol (Yaz) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
Summary
The purpose of this study is to determine whether the study drug is safe and effective
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: Red Blood Cell (RBC) Folate Level at 24 WeeksPlasma Folate Level at 24 Weeks
Secondary outcome: Mean Neural Tube Defect (NTD) Risk Reduction at Week 24Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 4 Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 8 Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 12 Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 16 Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 20 Mean Change From Baseline in Plasma Folate Levels at Week 4 Mean Change From Baseline in Plasma Folate Levels at Week 8 Mean Change From Baseline in Plasma Folate Levels at Week 12 Mean Change From Baseline in Plasma Folate Levels at Week 16 Mean Change From Baseline in Plasma Folate Levels at Week 20 Mean Change From Baseline in Plasma Homocysteine Levels at Week 4 Mean Change From Baseline in Plasma Homocysteine Levels at Week 8 Mean Change From Baseline in Plasma Homocysteine Levels at Week 12 Mean Change From Baseline in Plasma Homocysteine Levels at Week 16 Mean Change From Baseline in Plasma Homocysteine Levels at Week 20 Mean Change From Baseline in Plasma Homocysteine Levels at Week 24
Detailed description:
Acronym is used in result section: suspected/diagnosed (susp/diag)
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
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
Locations and Contacts
Orange County Clinical Trials, Anaheim, California 92801, United States
Medical Center for Clinical Research, San Diego, California 92108, United States
SNBL Clinical Pharmacology Center, Inc., Baltimore, Maryland 21201, United States
Columbia University Medical Center, New York, New York 10032, United States
AAIPharma, Inc., Morrisville, North Carolina 27560, United States
Lyndhurst Gynecologic Associates, Winston-Salem, North Carolina 27103, United States
Coastal Carolina Research Center, Mt. Pleasant, South Carolina 29464, United States
New Orleans Center for Clinical Research, Knoxville, Tennessee 37920, United States
NorthWest Kinetics, Tacoma, Washington 98418, United States
Additional Information
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Starting date: April 2007
Last updated: April 4, 2014
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