EU/LA Pearl Index Study - Transdermal Contraceptive Patch

NCT00914693 | Completed Phase 3

• 3 other identifiers: 915542008-004214-27310801
• Study Type: interventional
• Target: 1,694
• Locations: 8 countries
• Sites: 66

Brief Summary

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

Conditions

Contraception

Keywords

Fertility control; Contraception

Outcome Measures

Primary Outcomes (1)

• Occurrence of pregnancy

  13 treatment cycles each consisting of 28 days and follow-up period of 14 days

Secondary Outcomes (3)

• Cervical smear

  13 treatment cycles each consisting of 28 days

• Adverse events

  13 treatment cycles each consisting of 28 days

• Bleeding pattern and cycle control

  13 treatment cycles each consisting of 28 days

Other Outcomes (2)

• Treatment compliance

  13 treatment cycles each consisting of 28 days

• Subjective assessment of satisfaction with the treatment

  13 treatment cycles each consisting of 28 days

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: Ethinylestradiol/Gestodene (BAY86-5016)

Interventions

Ethinylestradiol/Gestodene (BAY86-5016) DRUG

7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen

Arm 1

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Requiring contraception
• Normal cervical smear
• Smokers not older than 30 years
• History of regular cyclic menstrual periods

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (66)

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Lanús Oeste, Buenos Aires, 1824, Argentina

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San Isidro, Buenos Aires, B1642CLN, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires, C1280AEB, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires, C1425ASQ, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires, C1425AWC, Argentina

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Rosario, Santa Fe Province, 2000, Argentina

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Ashfield, New South Wales, 2031, Australia

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Adelaide, South Australia, 5000, Australia

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North Adelaide, South Australia, 5006, Australia

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Clayton, Victoria, 3168, Australia

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Nedlands, Western Australia, 6009, Australia

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Temuco, Región de la Araucanía, 4791348, Chile

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Santiago, Santiago Metropolitan, 7510025, Chile

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Santiago, Santiago Metropolitan, 8350488, Chile

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Santiago, 8320165, Chile

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Temuco, 4790711, Chile

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Biarritz, 64200, France

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Montargis, 45200, France

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Nîmes, 30029, France

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Quetigny, 21800, France

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Reims, 51092, France

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Saint-Germain-en-Laye, 78100, France

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Toulouse, 31000, France

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Frankfurt am Main, Hesse, 60590, Germany

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Aachen, North Rhine-Westphalia, 52072, Germany

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Cologne, North Rhine-Westphalia, 50924, Germany

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Siegen, North Rhine-Westphalia, 57072, Germany

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Wuppertal, North Rhine-Westphalia, 42103, Germany

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Dippoldiswalde, Saxony, 01744, Germany

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Dresden, Saxony, 01099, Germany

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Leipzig, Saxony, 04207, Germany

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Leipzig, Saxony, 04299, Germany

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Blankenburg, Saxony-Anhalt, 38889, Germany

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Jessen, Saxony-Anhalt, 06917, Germany

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Magdeburg, Saxony-Anhalt, 39104, Germany

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Berlin, State of Berlin, 10247, Germany

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Berlin, State of Berlin, 12587, Germany

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Berlin, State of Berlin, 13507, Germany

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Gera, Thuringia, 07545, Germany

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Francavilla Fontana, Brindisi, 72021, Italy

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Bologna, 40138, Italy

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Cagliari, 09124, Italy

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Catanzaro, 88100, Italy

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Florence, 50134, Italy

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Modena, 41124, Italy

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Palermo, 90127, Italy

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Pavia, 27100, Italy

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Perugia, 06156, Italy

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Pisa, 56126, Italy

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Siena, 53100, Italy

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Chihuahua City, Chihuahua, 31350, Mexico

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Torreón, Coahuila, 27000, Mexico

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San Luis Potosí City, San Luis Potosí, 78230, Mexico

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Mexico City, 11000, Mexico

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México D.F., 10700, Mexico

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México, D.F., 11000, Mexico

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Barcelona, Barcelona, 08013, Spain

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Barcelona, Barcelona, 08028, Spain

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San Fernando, Cádiz, 11100, Spain

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Lugo, Lugo, 27002, Spain

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Pamplona, Pamplona, 31015, Spain

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Vigo, Pontevedra, 36209, Spain

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Dos Hermanas, Sevilla, 41700, Spain

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Alava, Vitoria, 01004, Spain

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Zaragoza, Zaragoza, 50001, Spain

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Barcelona, 08035, Spain

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Related Links

• Click here and search for Bayer Product information provided by EMA

MeSH Terms

Interventions

Ethinyl Estradiol; Gestodene

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2009
• First Posted: June 5, 2009
• Study Start: April 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

AU (5); DE (16); FR (7); CL (5); AR (6); ES (10); IT (11); ME (6)