Yasmin 20 Cycle Control - Yasmin 20 Versus Mercilon in Healthy Female Volunteers

Phase 3CompletedNCT00624130

Bayer453 enrolled

Overview

The purpose of this study is to compare bleeding pattern of contraceptive Yasmin 20 to a marketed comparator.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

453

Conditions

Contraception

Interventions

Yasmin 20DRUG

Yasmin 20, 24-d regimen vs Mercilon, Tablet p.o. (oral)

MercilonDRUG

Mercilon, 24-d regimen vs Yasmin 20 , Tablet p.o. (oral)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy female volunteer aged 18-35, * Smokers 18-30 Exclusion Criteria: * Contraindications for using hormonal contraceptives

Locations (17)

Unnamed facility

Horn, Austria

Unnamed facility

Leibnitz, Styria, Austria

Unnamed facility

Mödling, Austria

Outcomes

Primary Outcomes

Cycle control and bleeding pattern

Time frame: 7 cycles

Secondary Outcomes

Pearl index

Time frame: 7 cycles

Laboratory tests

Time frame: Screening

Adverse Events

Time frame: 7 cycles

General Physical and gynecological examinations

Time frame: Screening

Vital signs

Time frame: Screening, admission

Body weight

Time frame: Screening, admission

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.