Skip to main content
OpenTrials
Completed

NCT Number: NCT00185367

Comparative Cycle Control Europe

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Contraception

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Soukroma gynekologicka ambulance, Fulnek, Czechia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy female volunteers aged between 18 and 50 years requiring contraception

Exclusion criteria

  • Pregnancy or lactation
  • Any conditions that might interfere with the outcome as well as all contraindications for OC use

Treatment and study plan

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

Drug

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

SH D 593 B (Miranova)

Drug

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

Primary outcomes

  1. Bleeding pattern

    Time frame: 7 treatment cycles each consisting of 28 days

  2. Number of unintended pregnancies

    Time frame: 7 treatment cycles each consisting of 28 days and follow-up period of 14 days

Secondary outcomes

  1. Adverse event collection

    Time frame: 7 treatment cycles each consisting of 28 days and follow-up period of 14 days

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Multi-center, Double-blind, Double-dummy, Controlled, Randomized Study to Evaluate Cycle Control and Safety of a Four Phasic Oral Contraceptive (SH T00658ID) in Comparison to an Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D 593 B) in Healthy Female Volunteers Aged Between 18 and 50 Years.

Important dates

Study start
2005
Study completion
2006
First posted
Sep 16, 2005
Registry last updated
Jul 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.