Trial Condition(s):
Neural Tube Defects, Contraception, Oral Contraceptives (OC)
Efficacy and Safety Study for an Oral Contraceptive Containing Folate
Bayer Identifier:
91523
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The purpose of this study is to determine whether the study drug is safe and effective
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Orange County Clinical Trials Anaheim, United States, 92801 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Center for Clinical Research San Diego, United States, 92108 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SNBL Clinical Pharmacology Center, Inc. Baltimore, United States, 21201 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AAIPharma, Inc. Morrisville, United States, 27560 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Coastal Carolina Research Center Mt. Pleasant, United States, 29464 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations NorthWest Kinetics Tacoma, United States, 98418 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations New Orleans Center for Clinical Research Knoxville, United States, 37920 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Columbia University Medical Center New York, United States, 10032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lyndhurst Gynecologic Associates Winston-Salem, United States, 27103 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Red Blood Cell (RBC) Folate Level at 24 WeeksTimeframe: Week 24
- Plasma Folate Level at 24 WeeksTimeframe: Week 24
Secondary Outcome
- Mean Neural Tube Defect (NTD) Risk Reduction at Week 24Timeframe: Baseline and week 24
- Mean change from baseline in red blood cell (RBC) folate levels at week 4Timeframe: baseline and up to week 4
- Mean change from baseline in red blood cell (RBC) folate levels at week 8Timeframe: baseline and up to week 8
- Mean change from baseline in red blood cell (RBC) folate levels at week 12Timeframe: baseline and up to week 12
- Mean change from baseline in red blood cell (RBC) folate levels at week 16Timeframe: baseline and up to week 16
- Mean change from baseline in red blood cell (RBC) folate levels at week 20Timeframe: baseline and up to week 20
- Mean change from baseline in plasma folate levels at week 4Timeframe: baseline and up to week 4
- Mean change from baseline in plasma folate levels at week 8Timeframe: baseline and up to week 8
- Mean change from baseline in plasma folate levels at week 12Timeframe: baseline and up to week 12
- Mean change from baseline in plasma folate levels at week 16Timeframe: baseline and up to week 16
- Mean change from baseline in plasma folate levels at week 20Timeframe: baseline and up to week 20
- Mean change from baseline in plasma homocysteine levels at week 4Timeframe: baseline and up to week 4
- Mean change from baseline in plasma homocysteine levels at week 8Timeframe: baseline and up to week 8
- Mean change from baseline in plasma homocysteine levels at week 12Timeframe: baseline and up to week 12
- Mean change from baseline in plasma homocysteine levels at week 16Timeframe: baseline and up to week 16
- Mean change from baseline in plasma homocysteine levels at week 20Timeframe: baseline and up to week 20
- Mean change from baseline in plasma homocysteine levels at week 24Timeframe: baseline and up to week 24
Additional Information
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