Efficacy and Safety Study for an Oral Contraceptive Containing Folate
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00468481
First received: April 30, 2007
Last updated: October 31, 2012
Last verified: October 2012
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Purpose
The purpose of this study is to determine whether the study drug is safe and effective
| Condition | Intervention | Phase |
|---|---|---|
|
Neural Tube Defects Contraception Oral Contraceptives (OC) |
Drug: Drospirenone/Ethinylestradiol/Methyltetrahydrofolate Drug: Drospirenone/Ethinylestradiol (Yaz) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Red Blood Cell (RBC) Folate Level at 24 Weeks [ Time Frame: Week 24 ] [ Designated as safety issue: No ]RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
- Plasma Folate Level at 24 Weeks [ Time Frame: Week 24 ] [ Designated as safety issue: No ]Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Secondary Outcome Measures:
- Mean Neural Tube Defect (NTD) Risk Reduction at Week 24 [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]The mean NTD risk reduction evaluated as the change from Baseline to Week 24 in NTD risk based on the formula of Daly et al (J Amer Med Assoc 1995;274(21):1698-702); NTD risk=exp (1.6463-1.2193 x natural log [RBC folate]) where natural log [RBC folate] is the natural log of RBC folate measured in nmol/L; Change from Baseline to Week 24 in NTD risk=NTD risk at Week 24 - NTD risk at Baseline
- Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 4 [ Time Frame: baseline and up to week 4 ] [ Designated as safety issue: No ]RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
- Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 8 [ Time Frame: baseline and up to week 8 ] [ Designated as safety issue: No ]RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
- Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 12 [ Time Frame: baseline and up to week 12 ] [ Designated as safety issue: No ]RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
- Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 16 [ Time Frame: baseline and up to week 16 ] [ Designated as safety issue: No ]RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
- Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 20 [ Time Frame: baseline and up to week 20 ] [ Designated as safety issue: No ]RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
- Mean Change From Baseline in Plasma Folate Levels at Week 4 [ Time Frame: baseline and up to week 4 ] [ Designated as safety issue: No ]Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
- Mean Change From Baseline in Plasma Folate Levels at Week 8 [ Time Frame: baseline and up to week 8 ] [ Designated as safety issue: No ]Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
- Mean Change From Baseline in Plasma Folate Levels at Week 12 [ Time Frame: baseline and up to week 12 ] [ Designated as safety issue: No ]Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
- Mean Change From Baseline in Plasma Folate Levels at Week 16 [ Time Frame: baseline and up to week 16 ] [ Designated as safety issue: No ]Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
- Mean Change From Baseline in Plasma Folate Levels at Week 20 [ Time Frame: baseline and up to week 20 ] [ Designated as safety issue: No ]Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
- Mean Change From Baseline in Plasma Homocysteine Levels at Week 4 [ Time Frame: baseline and up to week 4 ] [ Designated as safety issue: No ]Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.
- Mean Change From Baseline in Plasma Homocysteine Levels at Week 8 [ Time Frame: baseline and up to week 8 ] [ Designated as safety issue: No ]Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.
- Mean Change From Baseline in Plasma Homocysteine Levels at Week 12 [ Time Frame: baseline and up to week 12 ] [ Designated as safety issue: No ]Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.
- Mean Change From Baseline in Plasma Homocysteine Levels at Week 16 [ Time Frame: baseline and up to week 16 ] [ Designated as safety issue: No ]Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.
- Mean Change From Baseline in Plasma Homocysteine Levels at Week 20 [ Time Frame: baseline and up to week 20 ] [ Designated as safety issue: No ]Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.
- Mean Change From Baseline in Plasma Homocysteine Levels at Week 24 [ Time Frame: baseline and up to week 24 ] [ Designated as safety issue: No ]Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.
| Enrollment: | 385 |
| Study Start Date: | April 2007 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)
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
0.020 mg ethinylestradiol with 3.0 mg drospirenone and 0.451 mg L-5-methyltetrahydrofolate (L-5-MTHF)
|
|
Active Comparator: Drospirenone (DRSP)/Ethinylestradiol (EE)
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)
0.020 mg ethinylestradiol with 3.0 mg drospirenone
|
Detailed Description:
Acronym is used in result section: suspected/diagnosed (susp/diag)
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00468481
Locations
| United States, California | |
| Orange County Clinical Trials | |
| Anaheim, California, United States, 92801 | |
| Medical Center for Clinical Research | |
| San Diego, California, United States, 92108 | |
| United States, Maryland | |
| SNBL Clinical Pharmacology Center, Inc. | |
| Baltimore, Maryland, United States, 21201 | |
| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| AAIPharma, Inc. | |
| Morrisville, North Carolina, United States, 27560 | |
| Lyndhurst Gynecologic Associates | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, South Carolina | |
| Coastal Carolina Research Center | |
| Mt. Pleasant, South Carolina, United States, 29464 | |
| United States, Tennessee | |
| New Orleans Center for Clinical Research | |
| Knoxville, Tennessee, United States, 37920 | |
| United States, Washington | |
| NorthWest Kinetics | |
| Tacoma, Washington, United States, 98418 | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
Publications:
| Responsible Party: | Therapeutic Area Head, Bayer Healthcare Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00468481 History of Changes |
| Other Study ID Numbers: | 91523, 310662 |
| Study First Received: | April 30, 2007 |
| Results First Received: | January 4, 2011 |
| Last Updated: | October 31, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bayer:
|
Healthy women requesting contraception Folic Acid |
Additional relevant MeSH terms:
|
Neural Tube Defects Spinal Dysraphism Nervous System Malformations Nervous System Diseases Congenital Abnormalities Contraceptives, Oral Ethinyl Estradiol Drospirenone Folic Acid Drospirenone and ethinyl estradiol combination Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Vitamin B Complex Vitamins Micronutrients Growth Substances Hematinics Hematologic Agents Aldosterone Antagonists Hormone Antagonists |
ClinicalTrials.gov processed this record on May 23, 2013