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Clinical Trials/NCT00206583
NCT00206583
Completed
Phase 3

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

Bayer29 sites in 2 countries499 target enrollmentMarch 2005
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ConditionsContraception
InterventionsEV/DNG (Qlaira, BAY86-5027, SH T00658ID)
DrugsEV/DNG (Qlaira, BAY86-5027, SH T00658ID)

Overview

Phase
Phase 3
Intervention
EV/DNG (Qlaira, BAY86-5027, SH T00658ID)
Conditions
Contraception
Sponsor
Bayer
Enrollment
499
Locations
29
Primary Endpoint
Number of unintended pregnancies after 1 year
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 2005
End Date
July 2007
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 women between the ages of 18 and 35 years requiring contraception

Exclusion Criteria

  • •Pregnancy, lactation, and contraindication of combined oral contraceptive

Arms & Interventions

EV/DNG (Qlaira, BAY86-5027)

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

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

Outcomes

Primary Outcomes

Number of unintended pregnancies after 1 year

Time Frame: Throughout 1 year of treatment

Secondary Outcomes

  • Bleeding pattern and cycle control parameters after 1 year(Throughout 1 year of treatment)

Study Sites (29)

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