Efficacy and Safety Oral Contraceptive Study

Bayer1,113 enrolled

Overview

The purpose of this study is to determine whether the study drug is effective in prevention of pregnancy in healthy women in reproductive age

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,113

Conditions

Contraception

Interventions

YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)DRUG

Oral administration of YAZ (0.02mg ethinyl estradiol-ß-cyclodextrin clathrate and 3mg drospirenone, 24 day hormone tablets followed by 4 days of placebo tablets for 13 cycles

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy woman requesting contraception * Age between 18 and 35 years (inclusive), smokers maximum age of 30 years (inclusive) Exclusion Criteria: * Any conditions might interfere study outcome

Outcomes

Primary Outcomes

Rate of unintended pregnancies (Pearl index)

Time frame: 13 cycles of 28 days

Secondary Outcomes

Physical and gynecological examination

Time frame: screening, cycle 6 and final examination

Vital signs

Time frame: each visit

Body weight

Time frame: each visit

Cervical smear

Time frame: each visit

Data from ClinicalTrials.gov

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