Phase 3
N=385
Efficacy and Safety Study for an Oral Contraceptive Containing Folate
Neural Tube Defects · Contraception · Oral Contraceptives (OC)
Bottom Line
View on ClinicalTrials.gov: NCT00468481 ↗Enrolled (actual)
385
Serious AEs
0.8%
Results posted
Jan 2011
Primary outcome: Primary: Red Blood Cell (RBC) Folate Level at 24 Weeks — 1406.91; 1022.21 nmol/L — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Drospirenone/Ethinylestradiol/Methyltetrahydrofolate (Drug); Drospirenone/Ethinylestradiol (Yaz) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Bayer
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Red Blood Cell (RBC) Folate Level at 24 Weeks |
1406.91; 1022.21 | <0.0001 sig |
| PRIMARY Plasma Folate Level at 24 Weeks |
60.55; 41.67 | <0.0001 sig |
| SECONDARY Mean Neural Tube Defect (NTD) Risk Reduction at Week 24 |
-0.51; -0.03 | — |
| SECONDARY Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 4 |
110.9; -37.6 | — |
| SECONDARY Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 8 |
310.3; 68.2 | — |
| SECONDARY Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 12 |
405.8; 86.5 | — |
| SECONDARY Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 16 |
448.9; 68.0 | — |
| SECONDARY Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 20 |
452.7; 64.6 | — |
| SECONDARY Mean Change From Baseline in Plasma Folate Levels at Week 4 |
15.2; 0.6 | — |
| SECONDARY Mean Change From Baseline in Plasma Folate Levels at Week 8 |
18.4; 2.2 | — |
| SECONDARY Mean Change From Baseline in Plasma Folate Levels at Week 12 |
17.6; 0.3 | — |
| SECONDARY Mean Change From Baseline in Plasma Folate Levels at Week 16 |
17.6; 2.4 | — |
| SECONDARY Mean Change From Baseline in Plasma Folate Levels at Week 20 |
15.1; -1.6 | — |
| SECONDARY Mean Change From Baseline in Plasma Homocysteine Levels at Week 4 |
0; 0 | — |
| SECONDARY Mean Change From Baseline in Plasma Homocysteine Levels at Week 8 |
-0.2; 0 | — |
| SECONDARY Mean Change From Baseline in Plasma Homocysteine Levels at Week 12 |
-0.3; 0 | — |
| SECONDARY Mean Change From Baseline in Plasma Homocysteine Levels at Week 16 |
-0.2; -0.1 | — |
| SECONDARY Mean Change From Baseline in Plasma Homocysteine Levels at Week 20 |
-0.2; -0.2 | — |
| SECONDARY Mean Change From Baseline in Plasma Homocysteine Levels at Week 24 |
-0.3; 0.1 | — |
Summary
The purpose of this study is to determine whether the study drug is safe and effective
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00468481). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.