Conditions: Neural Tube Defects Contraception Oral Contraceptives (OC)
Keywords: Healthy women requesting contraception Folic Acid
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 385
Healthy volunteers: yes

Brief summary:
The purpose of this study is to determine whether the study drug is safe and effective

Detailed description:
Acronym is used in result section: suspected/diagnosed (susp/diag)

Arms:
arm 1: 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 arm 2: 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

Interventions: intervention 1: Drospirenone/Ethinylestradiol/Methyltetrahydrofolate intervention 2: Drospirenone/Ethinylestradiol (Yaz)
Intervention descriptions: intervention 1: 0.020 mg ethinylestradiol with 3.0 mg drospirenone and 0.451 mg L-5-methyltetrahydrofolate (L-5-MTHF) intervention 2: 0.020 mg ethinylestradiol with 3.0 mg drospirenone

Protocol document: