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Study to Investigate Efficacy and Safety of a New Oral Contraceptive

NCT00185289 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1392

Last updated 2011-07-15

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and effectiveness of a new 4-phasic preparation in the prevention of pregnancies in a large group of volunteers.

Conditions

  • Contraception

Interventions

DRUG

EV/DNG (Qlaira, BAY86-5027, SH T00658K)

per cycle (28 days): Days 1-2: 3.0 mg EV; Days 3-7: 2.0 mg EV + 2.0 mg DNG; Days 8-24: 2.0 mg EV + 3.0 mg DNG; Days 25-26: 1.0 mg EV; Days 27-28: Placebo

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-04-30
Completion
2006-07-31

Countries

  • Austria
  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00185289 on ClinicalTrials.gov