Clinical trial NCT00914693: EU/LA Pearl Index Study - Transdermal Contraceptive Patch
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: Fertility control
Contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-06-05
Enrollment: 1694
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of pregnancy
timeFrame: 13 treatment cycles each consisting of 28 days and follow-up period of 14 days
Secondary outcomes:
measure: Cervical smear
timeFrame: 13 treatment cycles each consisting of 28 days
measure: Adverse events
timeFrame: 13 treatment cycles each consisting of 28 days
measure: Bleeding pattern and cycle control
timeFrame: 13 treatment cycles each consisting of 28 days
Other outcomes:
measure: Treatment compliance
timeFrame: 13 treatment cycles each consisting of 28 days
measure: Subjective assessment of satisfaction with the treatment
timeFrame: 13 treatment cycles each consisting of 28 days
Locations:
city: Lanus Oeste
country: Argentina
state: Buenos Aires
city: San Isidro
country: Argentina
state: Buenos Aires
city: Buenos Aires
country: Argentina
state: Ciudad Auton. de Buenos Aires
city: Buenos Aires
country: Argentina
state: Ciudad Auton. de Buenos Aires
city: Buenos Aires
country: Argentina
state: Ciudad Auton. de Buenos Aires
city: Rosario
country: Argentina
state: Santa Fe
city: Ashfield
country: Australia
state: New South Wales
city: Adelaide
country: Australia
state: South Australia
city: North Adelaide
country: Australia
state: South Australia
city: Clayton
country: Australia
state: Victoria
city: Nedlands
country: Australia
state: Western Australia
city: Temuco
country: Chile
state: Araucanía
city: Santiago
country: Chile
city: Santiago
country: Chile
city: Santiago
country: Chile
city: Temuco
country: Chile
city: Biarritz
country: France
city: Montargis
country: France
city: Nimes
country: France
city: Quetigny
country: France
city: REIMS Cedex
country: France
city: Saint Germain En Laye
country: France
city: Toulouse
country: France
city: Frankfurt
country: Germany
state: Hessen
city: Aachen
country: Germany
state: Nordrhein-Westfalen
city: Köln
country: Germany
state: Nordrhein-Westfalen
city: Siegen
country: Germany
state: Nordrhein-Westfalen
city: Wuppertal
country: Germany
state: Nordrhein-Westfalen
city: Blankenburg
country: Germany
state: Sachsen-Anhalt
city: Jessen
country: Germany
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Dippoldiswalde
country: Germany
state: Sachsen
city: Dresden
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Gera
country: Germany
state: Thüringen
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Francavilla Fontana
country: Italy
state: Brindisi
city: Bologna
country: Italy
city: Cagliari
country: Italy
city: Catanzaro
country: Italy
city: Firenze
country: Italy
city: Modena
country: Italy
city: Palermo
country: Italy
city: Pavia
country: Italy
city: Perugia
country: Italy
city: Pisa
country: Italy
city: Siena
country: Italy
city: Torreón
country: Mexico
state: Coahuila
city: Chihuahua
country: Mexico
city: Mexico D.F.
country: Mexico
city: México D.F.
country: Mexico
city: México, D.F.
country: Mexico
city: San Luis Potosí
country: Mexico
city: San Fernando
country: Spain
state: Cádiz
city: Vigo
country: Spain
state: Pontevedra
city: Dos Hermanas
country: Spain
state: Sevilla
city: Alava
country: Spain
state: Vitoria
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Lugo
country: Spain
city: Pamplona
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: