Trial Condition(s):
Neural Tube Defects, Contraception, Oral Contraceptives (OC)
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
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 | Status | ||
|---|---|---|---|
Locations Orange County Clinical Trials Anaheim, United States, 92801 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Medical Center for Clinical Research San Diego, United States, 92108 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations SNBL Clinical Pharmacology Center, Inc. Baltimore, United States, 21201 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations AAIPharma, Inc. Morrisville, United States, 27560 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Coastal Carolina Research Center Mt. Pleasant, United States, 29464 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations NorthWest Kinetics Tacoma, United States, 98418 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations New Orleans Center for Clinical Research Knoxville, United States, 37920 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Columbia University Medical Center New York, United States, 10032 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Lyndhurst Gynecologic Associates Winston-Salem, United States, 27103 | Status Completed | 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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