Efficacy and Safety Study for an Oral Contraceptive Containing Folate

Bayer

Status and phase: Completed; Phase 3

Conditions: Neural Tube Defects; Contraception; Oral Contraceptives (OC)

Treatments: Drug: Drospirenone/Ethinylestradiol/Methyltetrahydrofolate; Drug: Drospirenone/Ethinylestradiol (Yaz)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00468481

310662 (Other Identifier)

91523

Details and patient eligibility

About

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

Full description

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

Enrollment: 385 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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385 participants in 2 patient groups

Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)

Experimental 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

Treatment:

Drug: Drospirenone/Ethinylestradiol/Methyltetrahydrofolate

Drospirenone (DRSP)/Ethinylestradiol (EE)

Active Comparator group

Description:

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

Treatment:

Drug: Drospirenone/Ethinylestradiol (Yaz)