Trial Condition(s):

Contraception

EU/LA Pearl Index study - transdermal contraceptive patch

Bayer Identifier:

91554

ClinicalTrials.gov Identifier:

NCT00914693

EudraCT Number:

2008-004214-27

Study Completed

Trial Purpose

The aim of the present study is to prove efficacy and safety of a new contraceptive patch.

Inclusion Criteria
- Requiring contraception
 - Normal cervical smear 
 - Smokers not older than 30 years 
 - History of regular cyclic menstrual periods
Exclusion Criteria
- Pregnancy or lactation
 - Obesity (BMI> 30 kg/m2
 - Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
 - Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
 - Use of other contraceptive methods than study medication

Trial Summary

Enrollment Goal
1694
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Gestodene/EE Patch (BAY86-5016)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Frauenarztpraxis Hr. Dr. H. Lindecke

Berlin, Germany, 10247

Status
Completed
 
Locations

Praxis Dr. S. Mucha & Dr. G. Schalk

Wuppertal, Germany, 42103

Status
Completed
 
Locations

Praxis Hr. H. Thelen

Jessen, Germany, 06917

Status
Completed
 
Locations

Frauenarztpraxis Dr. Wetzel

Blankenburg, Germany, 38889

Status
Completed
 
Locations

Klinikum der Johann Wolfgang Goethe Universität Frankfurt

Frankfurt, Germany, 60590

Status
Completed
 
Locations

Praxis Hr. Dr. R. Etzrodt

Gera, Germany, 07545

Status
Completed
 
Locations

Frauenarztpraxis Dr. Robert Hantschel

Dippoldiswalde, Germany, 01744

Status
Completed
 
Locations

Praxis Hr. R. Wähnert

Gera, Germany, 07545

Status
Completed
 
Locations

Cabinet medical

Quetigny, France, 21800

Status
Completed
 
Locations

Cabinet gynecologie

BIARRITZ, France, 64200

Status
Completed
 
Locations

Centre Hospitalier Universitaire

Nimes, France, 30029

Status
Completed
 
Locations

Cabinet gynecologie

MONTARGIS, France, 45200

Status
Completed
 
Locations

A.O. di Perugia

Perugia, Italy, 06156

Status
Completed
 
Locations

A.O.U. di Modena Policlinico

Modena, Italy, 41124

Status
Completed
 
Locations

A.O.U. di Cagliari

Cagliari, Italy, 09124

Status
Completed
 
Locations

Praxis Fr. C. Burgkhardt

Leipzig, Germany, 04299

Status
Completed
 
Locations

Universitätsklinikum Köln

Köln, Germany, 50924

Status
Completed
 
Locations

Praxis Hr. Dr. A. Gerick

Aachen, Germany, 52072

Status
Completed
 
Locations

Praxis Fr. Dr. B. Heuberger

Berlin, Germany, 12587

Status
Completed
 
Locations

Praxis Fr. Dr. K. Maar

Berlin, Germany, 13507

Status
Completed
 
Locations

Frauenarztpraxis Dr. Bernd Pittner

Leipzig, Germany, 04207

Status
Completed
 
Locations

Praxis Hr. Dr. I. Urlea-Schön

Siegen, Germany, 57072

Status
Completed
 
Locations

Praxis Fr. Dr. A. Braune

Magdeburg, Germany, 39104

Status
Completed
 
Locations

Praxis Fr. Dr. G. Gollnick

Dresden, Germany, 01099

Status
Completed
 
Locations

Centre Hospitalier Universitaire de Reims

REIMS Cedex, France, 51092

Status
Completed
 
Locations

Cabinet gynecologie

SAINT GERMAIN EN LAYE, France, 78100

Status
Completed
 
Locations

Dr. Aliette Siboni-Frisch

Toulouse, France, 31000

Status
Completed
 
Locations

A.O.U. Senese

Siena, Italy, 53100

Status
Completed
 
Locations

A.O.U. Careggi

Firenze, Italy, 50134

Status
Completed
 
Locations

A.O.U. Pisana

Pisa, Italy, 56126

Status
Completed
 
Locations

AUSL Brindisi - Puglia

Francavilla Fontana, Italy, 72021

Status
Completed
 
Locations

A.O. Pugliese-Ciaccio

Catanzaro, Italy, 88100

Status
Completed
 
Locations

Hospital Santiago Apostol

Alava, Spain, 01004

Status
Completed
 
Locations

Centro de Planificación Familiar Dos Hermanas

Dos Hermanas, Spain, 41700

Status
Completed
 
Locations

Hospital Central Universitario

Chihuahua, Mexico, 31350

Status
Completed
 
Locations

Royal Adelaide Hospital

Adelaide, Australia, 5000

Status
Completed
 
Locations

Queen Elizabeth II Medical Centre

Nedlands, Australia, 6009

Status
Completed
 
Locations

Monash Medical Centre

Clayton, Australia, 3168

Status
Completed
 
Locations

Hospital Británico

Buenos Aires, Argentina, C1280AEB

Status
Terminated
 
Locations

Instituto Ginecologico Buenos Aires

Lanus Oeste, Argentina, 1824

Status
Terminated
 
Locations

Hospital Bernardino Rivadavia

Buenos Aires, Argentina, C1425ASQ

Status
Terminated
 
Locations

Hospital San Juan de Dios

Santiago, Chile, 8350488

Status
Completed
 
Locations

Consultorio Dr. Sánchez

Temuco, Chile, 4791348

Status
Completed
 
Locations

Instituto Chileno de Medicina Reproductiva

Santiago, Chile, 8320165

Status
Completed
 
Locations

IRCCS Fondazione Maugeri Clinica Lavoro e Riabilitazione

Pavia, Italy, 27100

Status
Completed
 
Locations

A.O.U. Policlinico Giaccone

Palermo, Italy, 90127

Status
Completed
 
Locations

A.O.U. di Bologna - Policlinico S.Orsola-Malpighi

Bologna, Italy, 40138

Status
Completed
 
Locations

Clínica Diatros

Barcelona, Spain, 08013

Status
Completed
 
Locations

USP Institut Universitari Dexeus

Barcelona, Spain, 08028

Status
Completed
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Completed
 
Locations

Centro Doctor Cayetano Roldán Moreno

San Fernando, Spain, 11100

Status
Completed
 
Locations

Centro de Atencion a la Mujer de Chantrea- Andraize

Pamplona, Spain, 31015

Status
Completed
 
Locations

Clínica Ginecológica CEOGA

Lugo, Spain, 27002

Status
Completed
 
Locations

Centro de Planificación Familiar COIA

Vigo, Spain, 36209

Status
Completed
 
Locations

Centro de Especialidades Inocencio Jimenez

Zaragoza, Spain, 50001

Status
Completed
 
Locations

Centro Inv. Biomédica, Fac. de Medicina de Torreón

Torreón, Mexico, 27000

Status
Completed
 
Locations

Consultorio Dra. De Anda

Mexico D.F., Mexico, 11000

Status
Completed
 
Locations

Hospital Ángeles del Pedregal

México D.F., Mexico, 10700

Status
Completed
 
Locations

Instituto Nacional de Perinatología

México, D.F., Mexico, 11000

Status
Terminated
 
Locations

Gynekos, Centro de Ginecología y Obstetricia.

San Luis Potosí, Mexico, 78230

Status
Completed
 
Locations

Women's and Children's Hospital

North Adelaide, Australia, 5006

Status
Completed
 
Locations

Sydney Centre for Reproductive Health Reseach

Ashfield, Australia, 2031

Status
Completed
 
Locations

Instituto Médico de Asistencia e Investigación

Buenos Aires, Argentina, C1425AWC

Status
Terminated
 
Locations

Cruz Azul Complejo de Salud

Rosario, Argentina, 2000

Status
Terminated
 
Locations

Clinica de la Mujer San Isidro Labrador - Ginec

San Isidro, Argentina, B1642CLN

Status
Terminated
 
Locations

Consultorio Miraflores

Temuco, Chile, 4790711

Status
Completed
 
Locations

Consultorio Dr. Vera

Santiago, Chile, 7510025

Status
Completed
 

Trial Design