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Comparative Cycle Control Europe

NCT00185367 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 798

Last updated 2011-07-15

No results posted yet for this study

Summary

The aim of this study is to evaluate bleeding pattern, cycle control, and safety of this new four-phasic oral contraceptive in comparison to a reference OC.

Conditions

  • Contraception

Interventions

DRUG

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

7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-2: 3.0 mg EV; Day 3-7: 2.0 mg EV + 2.0 mg DNG; Day 8-24: 2.0 mg EV + 3.0 mg DNG; Day 25-26: 1.0 mg EV; Day 27-28: placebo;In addition SH D 593 B (Miranova) matching placebo

DRUG

SH D 593 B (Miranova)

7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-21: 0.02 mg EE + 0.10 mg LNG; Day 22-28: placebo; In addition EV/DNG (Qlaira, BAY86-5027, SH T00658K) matching placebo

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-03-31
Completion
2006-09-30

Countries

  • Czechia
  • France
  • Germany

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 NCT00185367 on ClinicalTrials.gov