Multi-center, Open, Uncontrolled Study to Investigate the Efficacy and Safety of the Oral Contraceptive SH T 186 D Containing 0.02 mg Ethinylestradiol-b-cyclodextrin Clathrate and 3 mg Drospirenone in a 24-day Regimen for 13 Cycles in 1010 Healthy Female Volunteers

Bayer0 sites1,113 target enrollmentMarch 2004

ConditionsContraception

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

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

Overview

Phase: Phase 3
Intervention: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)
Conditions: Contraception
Sponsor: Bayer
Enrollment: 1113
Primary Endpoint: Rate of unintended pregnancies (Pearl index)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

Detailed 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.

Registry

clinicaltrials.gov

Start Date

March 2004

End Date

January 2006

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Arm 1

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

Outcomes

Primary Outcomes

Rate of unintended pregnancies (Pearl index)

Time Frame: 13 cycles of 28 days

Secondary Outcomes

Physical and gynecological examination(screening, cycle 6 and final examination)
Vital signs(each visit)
Body weight(each visit)
Cervical smear(each visit)