Efficacy and Safety Study of an Oral Contraceptive in Healthy Females

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00206583

Enrollment

499

Registered

2005-09-21

Start date

2005-03-31

Completion date

2007-07-31

Last updated

2014-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

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.

Interventions

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

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy women between the ages of 18 and 35 years requiring contraception

Exclusion criteria

* Pregnancy, lactation, and contraindication of combined oral contraceptive

Design outcomes

Primary

Measure	Time frame
Number of unintended pregnancies after 1 year	Throughout 1 year of treatment

Secondary

Measure	Time frame
Bleeding pattern and cycle control parameters after 1 year	Throughout 1 year of treatment

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026