At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 385 enrolled
Drug / intervention
Drospirenone/Ethinylestradiol/Methyltetrahydrofolate +1 moredrug
Likely dose
Drospirenone/Ethinylestradiol/Methyltetrahydrofolate 0.020 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Drospirenone/Ethinylestradiol/Methyltetrahydrofolate and Drospirenone/Ethinylestradiol (Yaz) for Neural Tube Defects and 2 related conditions. Completed, enrolled 385 participants across 9 sites.
Detailed Summary
The purpose of this study is to determine whether the study drug is safe and effective
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeural Tube Defects, Contraception, Oral Contraceptives (OC)
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2007
First PostedMay 2007
Primary CompletionAug 2008
Study CompletionSep 2008
TodayJul 2026
First PostedMay 2, 2007
Enrollment StartApr 1, 2007
Primary CompletionAug 1, 2008
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.2 years ago
Interventions
Drospirenone/Ethinylestradiol/Methyltetrahydrofolatedrug
0.020 mg ethinylestradiol with 3.0 mg drospirenone and 0.451 mg L-5-methyltetrahydrofolate (L-5-MTHF)
Drospirenone/Ethinylestradiol (Yaz)drug
0.020 mg ethinylestradiol with 3.0 mg drospirenone