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Efficacy and Safety Study for an Oral Contraceptive Containing Folate

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ClinicalTrials.gov Identifier: NCT00468481
Recruitment Status : Completed
First Posted : May 2, 2007
Results First Posted : January 25, 2011
Last Update Posted : April 23, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Neural Tube Defects
Contraception
Oral Contraceptives (OC)
Interventions Drug: Drospirenone/Ethinylestradiol/Methyltetrahydrofolate
Drug: Drospirenone/Ethinylestradiol (Yaz)
Enrollment 385
Recruitment Details  
Pre-assignment Details 572 subjects screened; 187 subjects screen failed; 385 subjects randomized
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description 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 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
Period Title: Overall Study
Started 291 [1] 94
Subjects Treated 285 94
Completed 203 70
Not Completed 88 24
Reason Not Completed
Adverse Event             13             3
Lost to Follow-up             25             8
Pregnancy             2             0
Protocol Violation             18             8
Withdrawal by Subject             12             3
susp/diag malignant/premalignant disease             1             0
Prohibited Medication             1             1
Egg Donor             1             0
Moved out of area             4             1
Non-Compliance             5             0
Other             6             0
[1]
6 of these randomized subjects did not take any study medication
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE) Total
Hide Arm/Group Description 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 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 Total of all reporting groups
Overall Number of Baseline Participants 285 94 379
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 285 participants 94 participants 379 participants
24.8
(18 to 40)
24.6
(18 to 39)
24.7
(18 to 40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 285 participants 94 participants 379 participants
Female
285
 100.0%
94
 100.0%
379
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Red Blood Cell (RBC) Folate Level at 24 Weeks
Hide Description RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 124 45
Least Squares Mean (95% Confidence Interval)
Unit of Measure: nmol/L
1406.91
(1354.13 to 1459.68)
1022.21
(934.6 to 1109.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF), Drospirenone (DRSP)/Ethinylestradiol (EE)
Comments The null hypothesis was that the difference between DRSP/EE/MTHF and Yaz treatment groups in the RBC folate levels at week 24 was 0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Analysis of Covariance (ANCOVA) with treatment as factor and Baseline (RBC folate) as covariate
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 384.70
Confidence Interval 95%
282.42 to 486.98
Estimation Comments Difference = DRSP/EE/MTHF - YAZ
2.Primary Outcome
Title Plasma Folate Level at 24 Weeks
Hide Description Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 196 66
Least Squares Mean (95% Confidence Interval)
Unit of Measure: nmol/L
60.55
(58.13 to 62.97)
41.67
(37.50 to 45.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF), Drospirenone (DRSP)/Ethinylestradiol (EE)
Comments The null hypothesis was that the difference between DRSP/EE/MTHF and Yaz treatment groups in the plasma folate levels at week 24 was 0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Analysis of Covariance (ANCOVA) with treatment as factor and Baseline (plasma folate) as covariate
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 18.87
Confidence Interval 95%
14.04 to 23.70
Estimation Comments Difference =DRSP/EE/MTHF - YAZ
3.Secondary Outcome
Title Mean Neural Tube Defect (NTD) Risk Reduction at Week 24
Hide Description 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
Time Frame Baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 124 45
Mean (Standard Deviation)
Unit of Measure: per 1000 birth
-0.51  (0.41) -0.03  (0.26)
4.Secondary Outcome
Title Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 4
Hide Description RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
Time Frame baseline and up to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 125 43
Mean (Standard Deviation)
Unit of Measure: nmol/L
110.9  (207.28) -37.6  (195.88)
5.Secondary Outcome
Title Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 8
Hide Description RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
Time Frame baseline and up to week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 122 43
Mean (Standard Deviation)
Unit of Measure: nmol/L
310.3  (231.47) 68.2  (155.26)
6.Secondary Outcome
Title Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 12
Hide Description RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
Time Frame baseline and up to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 127 41
Mean (Standard Deviation)
Unit of Measure: nmol/L
405.8  (243.88) 86.5  (177.81)
7.Secondary Outcome
Title Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 16
Hide Description RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
Time Frame baseline and up to week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 120 46
Mean (Standard Deviation)
Unit of Measure: nmol/L
448.9  (280.37) 68.0  (186.44)
8.Secondary Outcome
Title Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 20
Hide Description RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
Time Frame baseline and up to week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 123 44
Mean (Standard Deviation)
Unit of Measure: nmol/L
452.7  (284.64) 64.6  (194.89)
9.Secondary Outcome
Title Mean Change From Baseline in Plasma Folate Levels at Week 4
Hide Description Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Time Frame baseline and up to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 192 65
Mean (Standard Deviation)
Unit of Measure: nmol/L
15.2  (22.07) 0.6  (14.29)
10.Secondary Outcome
Title Mean Change From Baseline in Plasma Folate Levels at Week 8
Hide Description Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Time Frame baseline and up to week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 193 66
Mean (Standard Deviation)
Unit of Measure: µg/L
18.4  (19.17) 2.2  (14.63)
11.Secondary Outcome
Title Mean Change From Baseline in Plasma Folate Levels at Week 12
Hide Description Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Time Frame baseline and up to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 194 66
Mean (Standard Deviation)
Unit of Measure: nmol/L
17.6  (20.1) 0.3  (15.24)
12.Secondary Outcome
Title Mean Change From Baseline in Plasma Folate Levels at Week 16
Hide Description Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Time Frame baseline and up to week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 194 65
Mean (Standard Deviation)
Unit of Measure: nmol/L
17.6  (12.43) 2.4  (16.44)
13.Secondary Outcome
Title Mean Change From Baseline in Plasma Folate Levels at Week 20
Hide Description Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Time Frame baseline and up to week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 193 66
Mean (Standard Deviation)
Unit of Measure: nmol/L
15.1  (22.71) -1.6  (15.65)
14.Secondary Outcome
Title Mean Change From Baseline in Plasma Homocysteine Levels at Week 4
Hide Description Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.
Time Frame baseline and up to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 194 65
Mean (Standard Deviation)
Unit of Measure: µg/L
0  (1.04) 0  (0.69)
15.Secondary Outcome
Title Mean Change From Baseline in Plasma Homocysteine Levels at Week 8
Hide Description Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.
Time Frame baseline and up to week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 195 66
Mean (Standard Deviation)
Unit of Measure: µg/L
-0.2  (0.9) 0  (1)
16.Secondary Outcome
Title Mean Change From Baseline in Plasma Homocysteine Levels at Week 12
Hide Description Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.
Time Frame baseline and up to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 196 66
Mean (Standard Deviation)
Unit of Measure: µg/L
-0.3  (1.07) 0  (0.93)
17.Secondary Outcome
Title Mean Change From Baseline in Plasma Homocysteine Levels at Week 16
Hide Description Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.
Time Frame baseline and up to week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 194 65
Mean (Standard Deviation)
Unit of Measure: µg/L
-0.2  (1.02) -0.1  (0.93)
18.Secondary Outcome
Title Mean Change From Baseline in Plasma Homocysteine Levels at Week 20
Hide Description Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.
Time Frame baseline and up to week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 195 66
Mean (Standard Deviation)
Unit of Measure: µg/L
-0.2  (1.07) -0.2  (0.91)
19.Secondary Outcome
Title Mean Change From Baseline in Plasma Homocysteine Levels at Week 24
Hide Description Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.
Time Frame baseline and up to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 195 66
Mean (Standard Deviation)
Unit of Measure: µg/L
-0.3  (0.93) 0.1  (1.24)
20.Post-Hoc Outcome
Title Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Baseline
Hide Description RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
Time Frame at baseline (week 0)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 90 40
Mean (Standard Deviation)
Unit of Measure: nmol/L
910.9  (276.05) 915.1  (233.97)
21.Post-Hoc Outcome
Title Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Baseline
Hide Description RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
Time Frame at baseline (week 0)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 54 12
Mean (Standard Deviation)
Unit of Measure: nmol/L
1122.8  (504.7) 1345.0  (301.76)
22.Post-Hoc Outcome
Title Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 4
Hide Description RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
Time Frame up to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 80 35
Mean (Standard Deviation)
Unit of Measure: nmol/L
1007.1  (329.67) 889.5  (262.42)
23.Post-Hoc Outcome
Title Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 4
Hide Description RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
Time Frame up to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 50 9
Mean (Standard Deviation)
Unit of Measure: nmol/L
1175.7  (428.58) 1256.1  (190.89)
24.Post-Hoc Outcome
Title Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 8
Hide Description RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
Time Frame up to week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 76 33
Mean (Standard Deviation)
Unit of Measure: nmol/L
1184.8  (338.5) 970.4  (252.79)
25.Post-Hoc Outcome
Title Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 8
Hide Description RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
Time Frame up to week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 50 10
Mean (Standard Deviation)
Unit of Measure: nmol/L
1412.7  (436.69) 1407.6  (290.18)
26.Post-Hoc Outcome
Title Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 12
Hide Description RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
Time Frame up to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 79 33
Mean (Standard Deviation)
Unit of Measure: nmol/L
1308.9  (374.61) 1025.2  (287.55)
27.Post-Hoc Outcome
Title Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 12
Hide Description RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
Time Frame up to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 50 10
Mean (Standard Deviation)
Unit of Measure: nmol/L
1469.8  (454.62) 1378.4  (375.15)
28.Post-Hoc Outcome
Title Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 16
Hide Description RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
Time Frame up to week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 76 35
Mean (Standard Deviation)
Unit of Measure: nmol/L
1365.2  (403.12) 967.6  (255.78)
29.Post-Hoc Outcome
Title Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 16
Hide Description RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
Time Frame up to week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 50 11
Mean (Standard Deviation)
Unit of Measure: nmol/L
1460.5  (472.23) 1454.7  (355.5)
30.Post-Hoc Outcome
Title Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 20
Hide Description RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
Time Frame up to week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 78 33
Mean (Standard Deviation)
Unit of Measure: nmol/L
1419.8  (558.1) 981.3  (252.85)
31.Post-Hoc Outcome
Title Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 20
Hide Description RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
Time Frame up to week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 49 13
Mean (Standard Deviation)
Unit of Measure: nmol/L
1486.6  (462.8) 1435.9  (319.33)
32.Post-Hoc Outcome
Title Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 24
Hide Description RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
Time Frame up to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 87 37
Mean (Standard Deviation)
Unit of Measure: nmol/L
1355.3  (364.85) 949.2  (256.26)
33.Post-Hoc Outcome
Title Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 24
Hide Description RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit
Time Frame up to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 51 10
Mean (Standard Deviation)
Unit of Measure: nmol/L
1500.3  (525.71) 1316.1  (237.44)
34.Post-Hoc Outcome
Title Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Baseline
Hide Description Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Time Frame at baseline (week 0)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 120 47
Mean (Standard Deviation)
Unit of Measure: nmol/L
41.7  (16.2) 41.5  (15.57)
35.Post-Hoc Outcome
Title Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Baseline
Hide Description Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Time Frame at baseline (week 0)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 76 19
Mean (Standard Deviation)
Unit of Measure: nmol/L
50.3  (18.45) 47.1  (17.3)
36.Post-Hoc Outcome
Title Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 4
Hide Description Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Time Frame up to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 119 47
Mean (Standard Deviation)
Unit of Measure: nmol/L
59.6  (24.83) 43.1  (17.98)
37.Post-Hoc Outcome
Title Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 4
Hide Description Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Time Frame up to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 73 18
Mean (Standard Deviation)
Unit of Measure: nmol/L
60.4  (27.56) 45.9  (21.19)
38.Post-Hoc Outcome
Title Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 8
Hide Description Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Time Frame up to week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 118 47
Mean (Standard Deviation)
Unit of Measure: nmol/L
60.8  (22.41) 41.8  (14.96)
39.Post-Hoc Outcome
Title Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 8
Hide Description Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Time Frame up to week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 75 19
Mean (Standard Deviation)
Unit of Measure: nmol/L
68.1  (26.60) 54.1  (30.16)
40.Post-Hoc Outcome
Title Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 12
Hide Description Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Time Frame up to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 119 47
Mean (Standard Deviation)
Unit of Measure: nmol/L
59.5  (20.39) 42.3  (17.19)
41.Post-Hoc Outcome
Title Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 12
Hide Description Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Time Frame up to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 75 19
Mean (Standard Deviation)
Unit of Measure: nmol/L
67.4  (23.69) 46.4  (17.55)
42.Post-Hoc Outcome
Title Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 16
Hide Description Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Time Frame up to week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 118 46
Mean (Standard Deviation)
Unit of Measure: nmol/L
59.4  (18.89) 43.2  (18.4)
43.Post-Hoc Outcome
Title Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 16
Hide Description Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Time Frame up to week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 76 19
Mean (Standard Deviation)
Unit of Measure: nmol/L
67.5  (26.38) 51.8  (21.08)
44.Post-Hoc Outcome
Title Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 20
Hide Description Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Time Frame up to week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 118 47
Mean (Standard Deviation)
Unit of Measure: nmol/L
59.8  (21.11) 39.7  (16.74)
45.Post-Hoc Outcome
Title Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 20
Hide Description Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Time Frame up to week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 75 19
Mean (Standard Deviation)
Unit of Measure: nmol/L
61.5  (24.16) 45.9  (14.54)
46.Post-Hoc Outcome
Title Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 24
Hide Description Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Time Frame up to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 120 47
Mean (Standard Deviation)
Unit of Measure: nmol/L
58.7  (17.73) 39.8  (18.02)
47.Post-Hoc Outcome
Title Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 24
Hide Description Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
Time Frame up to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 76 19
Mean (Standard Deviation)
Unit of Measure: nmol/L
64.0  (22.61) 43.7  (16.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Hide Arm/Group Description 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 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
All-Cause Mortality
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/285 (1.05%)      0/94 (0.00%)    
Infections and infestations     
Pneumonia * 1  1/285 (0.35%)  1 0/94 (0.00%)  0
Investigations     
Human papilloma virus test positive * 1  1/285 (0.35%)  1 0/94 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cervix carcinoma stage 0 * 1  1/285 (0.35%)  1 0/94 (0.00%)  0
Reproductive system and breast disorders     
Cervical dysplasia * 1  1/285 (0.35%)  1 0/94 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF) Drospirenone (DRSP)/Ethinylestradiol (EE)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   103/285 (36.14%)      44/94 (46.81%)    
Gastrointestinal disorders     
Abdominal pain * 1  1/285 (0.35%)  1 3/94 (3.19%)  3
Infections and infestations     
Bronchitis * 1  6/285 (2.11%)  6 1/94 (1.06%)  1
Influenza * 1  6/285 (2.11%)  6 3/94 (3.19%)  3
Nasopharyngitis * 1  11/285 (3.86%)  11 2/94 (2.13%)  2
Pharyngitis * 1  1/285 (0.35%)  1 2/94 (2.13%)  2
Sinusitis * 1  9/285 (3.16%)  9 3/94 (3.19%)  3
Upper respiratory tract infection * 1  30/285 (10.53%)  32 9/94 (9.57%)  10
Urinary tract infection * 1  10/285 (3.51%)  11 2/94 (2.13%)  2
Investigations     
Blood cholinesterase decreased * 1  1/285 (0.35%)  1 2/94 (2.13%)  2
Blood triglycerides increased * 1  0/285 (0.00%)  0 2/94 (2.13%)  2
Gamma-glutamyltransferase increased * 1  2/285 (0.70%)  2 2/94 (2.13%)  2
Low density lipoprotein increased * 1  17/285 (5.96%)  17 8/94 (8.51%)  8
Prothrombin level decreased * 1  0/285 (0.00%)  0 2/94 (2.13%)  2
Human papilloma virus test positive * 1  10/285 (3.51%)  10 2/94 (2.13%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/285 (0.35%)  1 2/94 (2.13%)  2
Nervous system disorders     
Headache * 1  6/285 (2.11%)  9 4/94 (4.26%)  6
Migraine * 1  2/285 (0.70%)  3 2/94 (2.13%)  2
Psychiatric disorders     
Anxiety * 1  1/285 (0.35%)  1 3/94 (3.19%)  3
Reproductive system and breast disorders     
Cervical dysplasia * 1  10/285 (3.51%)  10 4/94 (4.26%)  4
Respiratory, thoracic and mediastinal disorders     
Cough * 1  5/285 (1.75%)  5 5/94 (5.32%)  5
Sinus congestion * 1  0/285 (0.00%)  0 2/94 (2.13%)  2
Oropharyngeal pain * 1  0/285 (0.00%)  0 2/94 (2.13%)  2
Skin and subcutaneous tissue disorders     
Rash * 1  5/285 (1.75%)  5 5/94 (5.32%)  5
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: BAYER
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00468481     History of Changes
Other Study ID Numbers: 91523
310662 ( Other Identifier: Company internal )
First Submitted: April 30, 2007
First Posted: May 2, 2007
Results First Submitted: January 4, 2011
Results First Posted: January 25, 2011
Last Update Posted: April 23, 2014