check_circleStudy Completed

Contraception

Bayer Identifier:

91554

ClinicalTrials.gov Identifier:

NCT00914693

EudraCT Number:

2008-004214-27

EU CT Number:

Not Available
EU/LA Pearl Index study - transdermal contraceptive patch

Trial purpose

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

Key Participants Requirements

Sex

Female

Age

18 - 35 Years
  • - Requiring contraception
    - Normal cervical smear
    - Smokers not older than 30 years
    - History of regular cyclic menstrual periods
  • - 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
April 2009 - September 2011
Phase
Phase 3
Could I Receive a placebo
No
Products
Gestodene/EE Patch (BAY86-5016)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Frauenarztpraxis Hr. Dr. H. LindeckeBerlin, 10247, Germany
Completed
Praxis Dr. S. Mucha & Dr. G. SchalkWuppertal, 42103, Germany
Completed
Praxis Hr. H. ThelenJessen, 06917, Germany
Completed
Frauenarztpraxis Dr. WetzelBlankenburg, 38889, Germany
Completed
Klinikum der Johann Wolfgang Goethe Universität FrankfurtFrankfurt, 60590, Germany
Completed
Praxis Hr. Dr. R. EtzrodtGera, 07545, Germany
Completed
Frauenarztpraxis Dr. Robert HantschelDippoldiswalde, 01744, Germany
Completed
Praxis Hr. R. WähnertGera, 07545, Germany
Completed
Cabinet medicalQuetigny, 21800, France
Completed
Cabinet gynecologieBIARRITZ, 64200, France
Completed
Centre Hospitalier UniversitaireNimes, 30029, France
Completed
Cabinet gynecologieMONTARGIS, 45200, France
Completed
A.O. di PerugiaPerugia, 06156, Italy
Completed
A.O.U. di Modena PoliclinicoModena, 41124, Italy
Completed
A.O.U. di CagliariCagliari, 09124, Italy
Completed
Praxis Fr. C. BurgkhardtLeipzig, 04299, Germany
Completed
Universitätsklinikum KölnKöln, 50924, Germany
Completed
Praxis Hr. Dr. A. GerickAachen, 52072, Germany
Completed
Praxis Fr. Dr. B. HeubergerBerlin, 12587, Germany
Completed
Praxis Fr. Dr. K. MaarBerlin, 13507, Germany
Completed
Frauenarztpraxis Dr. Bernd PittnerLeipzig, 04207, Germany
Completed
Praxis Hr. Dr. I. Urlea-SchönSiegen, 57072, Germany
Completed
Praxis Fr. Dr. A. BrauneMagdeburg, 39104, Germany
Completed
Praxis Fr. Dr. G. GollnickDresden, 01099, Germany
Completed
Centre Hospitalier Universitaire de ReimsREIMS Cedex, 51092, France
Completed
Cabinet gynecologieSAINT GERMAIN EN LAYE, 78100, France
Completed
Dr. Aliette Siboni-FrischToulouse, 31000, France
Completed
A.O.U. SeneseSiena, 53100, Italy
Completed
A.O.U. CareggiFirenze, 50134, Italy
Completed
A.O.U. PisanaPisa, 56126, Italy
Completed
AUSL Brindisi - PugliaFrancavilla Fontana, 72021, Italy
Completed
A.O. Pugliese-CiaccioCatanzaro, 88100, Italy
Completed
Hospital Santiago ApostolAlava, 01004, Spain
Completed
Centro de Planificación Familiar Dos HermanasDos Hermanas, 41700, Spain
Completed
Hospital Central UniversitarioChihuahua, 31350, Mexico
Completed
Royal Adelaide HospitalAdelaide, 5000, Australia
Completed
Queen Elizabeth II Medical CentreNedlands, 6009, Australia
Completed
Monash Medical CentreClayton, 3168, Australia
Terminated
Hospital BritánicoBuenos Aires, C1280AEB, Argentina
Terminated
Instituto Ginecologico Buenos AiresLanus Oeste, 1824, Argentina
Terminated
Hospital Bernardino RivadaviaBuenos Aires, C1425ASQ, Argentina
Completed
Hospital San Juan de DiosSantiago, 8350488, Chile
Completed
Consultorio Dr. SánchezTemuco, 4791348, Chile
Completed
Instituto Chileno de Medicina ReproductivaSantiago, 8320165, Chile
Completed
IRCCS Fondazione Maugeri Clinica Lavoro e RiabilitazionePavia, 27100, Italy
Completed
A.O.U. Policlinico GiacconePalermo, 90127, Italy
Completed
A.O.U. di Bologna - Policlinico S.Orsola-MalpighiBologna, 40138, Italy
Completed
Clínica DiatrosBarcelona, 08013, Spain
Completed
USP Institut Universitari DexeusBarcelona, 08028, Spain
Completed
Ciutat Sanitària i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Completed
Centro Doctor Cayetano Roldán MorenoSan Fernando, 11100, Spain
Completed
Centro de Atencion a la Mujer de Chantrea- AndraizePamplona, 31015, Spain
Completed
Clínica Ginecológica CEOGALugo, 27002, Spain
Completed
Centro de Planificación Familiar COIAVigo, 36209, Spain
Completed
Centro de Especialidades Inocencio JimenezZaragoza, 50001, Spain
Completed
Centro Inv. Biomédica, Fac. de Medicina de TorreónTorreón, 27000, Mexico
Completed
Consultorio Dra. De AndaMexico D.F., 11000, Mexico
Completed
Hospital Ángeles del PedregalMéxico D.F., 10700, Mexico
Terminated
Instituto Nacional de PerinatologíaMéxico, D.F., 11000, Mexico
Completed
Gynekos, Centro de Ginecología y Obstetricia.San Luis Potosí, 78230, Mexico
Completed
Women's and Children's HospitalNorth Adelaide, 5006, Australia
Completed
Sydney Centre for Reproductive Health ReseachAshfield, 2031, Australia
Terminated
Instituto Médico de Asistencia e InvestigaciónBuenos Aires, C1425AWC, Argentina
Terminated
Cruz Azul Complejo de SaludRosario, 2000, Argentina
Terminated
Clinica de la Mujer San Isidro Labrador - GinecSan Isidro, B1642CLN, Argentina
Completed
Consultorio MirafloresTemuco, 4790711, Chile
Completed
Consultorio Dr. VeraSantiago, 7510025, Chile

Primary Outcome

  • Occurrence of pregnancy
    date_rangeTime Frame:
    13 treatment cycles each consisting of 28 days and follow-up period of 14 days
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Cervical smear
    date_rangeTime Frame:
    13 treatment cycles each consisting of 28 days
    enhanced_encryption
    Safety Issue:
    yes
  • Adverse events
    date_rangeTime Frame:
    13 treatment cycles each consisting of 28 days
    enhanced_encryption
    Safety Issue:
    yes
  • Bleeding pattern and cycle control
    date_rangeTime Frame:
    13 treatment cycles each consisting of 28 days
    enhanced_encryption
    Safety Issue:
    no

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

Additional Information

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