Pearl Index Study With Low Dose Combined Oral Contraceptive

Bayer

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: Minisiston (SH D00342A)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00220324

91313

307987 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to investigate the contraceptive efficacy, bleeding pattern, and safety of SH D00342A. Subjects participating in the study will be treated with an oral contraceptive pill containing 0.03 mg ethinylestradiol and 0.125 mg levonorgestrel.

Full description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Enrollment: 840 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy women requiring contraception

Exclusion criteria

• Pregnant or lactating women, history or suspicion of hormone dependent tumor or any other conditions which forbid the participation.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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840 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Minisiston (SH D00342A)