Trial Condition(s):
Contraception
EU/LA Pearl Index study - transdermal contraceptive patch
Bayer Identifier:
91554
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Frauenarztpraxis Hr. Dr. H. Lindecke Berlin, Germany, 10247 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. S. Mucha & Dr. G. Schalk Wuppertal, Germany, 42103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. H. Thelen Jessen, Germany, 06917 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Frauenarztpraxis Dr. Wetzel Blankenburg, Germany, 38889 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Johann Wolfgang Goethe Universität Frankfurt Frankfurt, Germany, 60590 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. R. Etzrodt Gera, Germany, 07545 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Frauenarztpraxis Dr. Robert Hantschel Dippoldiswalde, Germany, 01744 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. R. Wähnert Gera, Germany, 07545 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet medical Quetigny, France, 21800 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet gynecologie BIARRITZ, France, 64200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier Universitaire Nimes, France, 30029 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet gynecologie MONTARGIS, France, 45200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. di Perugia Perugia, Italy, 06156 | Status Completed | Contact Us: E-mail: [email protected]re.com Phone: Not Available |
Locations A.O.U. di Modena Policlinico Modena, Italy, 41124 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Cagliari Cagliari, Italy, 09124 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. C. Burgkhardt Leipzig, Germany, 04299 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Köln Köln, Germany, 50924 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. A. Gerick Aachen, Germany, 52072 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. B. Heuberger Berlin, Germany, 12587 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. K. Maar Berlin, Germany, 13507 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Frauenarztpraxis Dr. Bernd Pittner Leipzig, Germany, 04207 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. I. Urlea-Schön Siegen, Germany, 57072 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. A. Braune Magdeburg, Germany, 39104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. G. Gollnick Dresden, Germany, 01099 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier Universitaire de Reims REIMS Cedex, France, 51092 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet gynecologie SAINT GERMAIN EN LAYE, France, 78100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Aliette Siboni-Frisch Toulouse, France, 31000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Senese Siena, Italy, 53100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Careggi Firenze, Italy, 50134 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Pisana Pisa, Italy, 56126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL Brindisi - Puglia Francavilla Fontana, Italy, 72021 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Pugliese-Ciaccio Catanzaro, Italy, 88100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Santiago Apostol Alava, Spain, 01004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Planificación Familiar Dos Hermanas Dos Hermanas, Spain, 41700 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Central Universitario Chihuahua, Mexico, 31350 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Adelaide Hospital Adelaide, Australia, 5000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Elizabeth II Medical Centre Nedlands, Australia, 6009 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Monash Medical Centre Clayton, Australia, 3168 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Británico Buenos Aires, Argentina, C1280AEB | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Ginecologico Buenos Aires Lanus Oeste, Argentina, 1824 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Bernardino Rivadavia Buenos Aires, Argentina, C1425ASQ | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital San Juan de Dios Santiago, Chile, 8350488 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Consultorio Dr. Sánchez Temuco, Chile, 4791348 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Chileno de Medicina Reproductiva Santiago, Chile, 8320165 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Fondazione Maugeri Clinica Lavoro e Riabilitazione Pavia, Italy, 27100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Policlinico Giaccone Palermo, Italy, 90127 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Bologna - Policlinico S.Orsola-Malpighi Bologna, Italy, 40138 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clínica Diatros Barcelona, Spain, 08013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations USP Institut Universitari Dexeus Barcelona, Spain, 08028 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Doctor Cayetano Roldán Moreno San Fernando, Spain, 11100 | Status Completed | Contact Us: E-mail: [email protected]rhealthcare.com Phone: Not Available |
Locations Centro de Atencion a la Mujer de Chantrea- Andraize Pamplona, Spain, 31015 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clínica Ginecológica CEOGA Lugo, Spain, 27002 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Planificación Familiar COIA Vigo, Spain, 36209 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Especialidades Inocencio Jimenez Zaragoza, Spain, 50001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Inv. Biomédica, Fac. de Medicina de Torreón Torreón, Mexico, 27000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Consultorio Dra. De Anda Mexico D.F., Mexico, 11000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Ángeles del Pedregal México D.F., Mexico, 10700 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Nacional de Perinatología México, D.F., Mexico, 11000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gynekos, Centro de Ginecología y Obstetricia. San Luis Potosí, Mexico, 78230 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's and Children's Hospital North Adelaide, Australia, 5006 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sydney Centre for Reproductive Health Reseach Ashfield, Australia, 2031 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Médico de Asistencia e Investigación Buenos Aires, Argentina, C1425AWC | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cruz Azul Complejo de Salud Rosario, Argentina, 2000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinica de la Mujer San Isidro Labrador - Ginec San Isidro, Argentina, B1642CLN | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Consultorio Miraflores Temuco, Chile, 4790711 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Consultorio Dr. Vera Santiago, Chile, 7510025 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Multicenter, open-label, uncontrolled study to investigate the efficacy and safety of the transdermal contraceptive patch containing 0.55 mg ethinyl estradiol and 2.1 mg gestodene (material no. 80876395) in a 21-day regimen for 13 cycles in 1650 healthy female subjects
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Occurrence of pregnancyTimeframe: 13 treatment cycles each consisting of 28 days and follow-up period of 14 days
Secondary Outcome
- Cervical smearTimeframe: 13 treatment cycles each consisting of 28 days
- Adverse eventsTimeframe: 13 treatment cycles each consisting of 28 days
- Bleeding pattern and cycle controlTimeframe: 13 treatment cycles each consisting of 28 days
Additional Information
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