Skip to main content
OpenTrials
Completed

NCT Number: NCT00206583

Efficacy and Safety Study of an Oral Contraceptive in Healthy Females

The purpose of this study is to determine whether the study drug is safe and effective in the prevention of pregnancies in a large group of volunteers.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Contraception

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Total Concept Health Care Inc., Kitchener, Ontario, Canada

Loading trial locations.

About this study

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals Inc.. Bayer HealthCare Pharmaceuticals Inc. 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 women between the ages of 18 and 35 years requiring contraception

Exclusion criteria

  • Pregnancy, lactation, and contraindication of combined oral contraceptive

Treatment and study plan

EV/DNG (Qlaira, BAY86-5027, SH T00658ID)

Drug

GA: Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral) Tablet, p.o. (oral)

Primary outcomes

  1. Number of unintended pregnancies after 1 year

    Time frame: Throughout 1 year of treatment

Secondary outcomes

  1. Bleeding pattern and cycle control parameters after 1 year

    Time frame: Throughout 1 year of treatment

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Multicenter, Open-label Uncontrolled Study to Investigate the Efficacy and Safety of a 4-phasic Oral Contraceptive SH T0065 in a 28-day Regimen for 13 Cycles in Healthy Female Subjects

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 21, 2005
Registry last updated
Oct 1, 2014

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.