Bleeding Pattern Study

Bayer1,315 enrolled

Overview

The aim of this study is to evaluate bleeding pattern, cycle control, contraceptive efficacy and safety of this oral contraceptive in two different regimens of intake.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,315

Conditions

Oral Contraceptive

Interventions

Valette (Dienogest/EE30, BAY86-5038)DRUG

Oral contraceptive extended cycles

Valette (Dienogest/EE30, BAY86-5038)DRUG

Oral contraceptive conventional cycles

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy female volunteers aged between 18 and 40 years requiring contraception. Exclusion Criteria: * Pregnancy or lactation. * Any conditions that might interfere with the outcome as well as all contraindications for OC use.

Locations (48)

Outcomes

Primary Outcomes

Bleeding pattern

Secondary Outcomes

Safety, contraceptive efficacy

Data from ClinicalTrials.gov

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Unnamed facility

Eberbach, Baden-Wurttemberg, Germany

Unnamed facility

Höchstadt A. D. Aisch, Bavaria, Germany

Unnamed facility

Krumbach, Bavaria, Germany

Unnamed facility

Neubiberg, Bavaria, Germany

Unnamed facility

Nuremberg, Bavaria, Germany

Unnamed facility

Hamburg, Hamburg, Germany

Unnamed facility

Hamburg, Hamburg, Germany

Unnamed facility

Dietzenbach, Hesse, Germany

Unnamed facility

Frankfurt am Main, Hesse, Germany

Unnamed facility

Frankfurt am Main, Hesse, Germany

...and 38 more locations