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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00914693




Registration number
NCT00914693
Ethics application status
Date submitted
5/05/2009
Date registered
4/06/2009
Date last updated
4/12/2014

Titles & IDs
Public title
EU/LA Pearl Index Study - Transdermal Contraceptive Patch
Scientific 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
Secondary ID [1] 0 0
2008-004214-27
Secondary ID [2] 0 0
91554
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contraception 0 0
Contraception 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ethinylestradiol/Gestodene (BAY86-5016)
Treatment: Drugs - Ethinylestradiol/Gestodene (BAY86-5016)

Experimental: Arm 1 -

Experimental: Arm 1 -


Treatment: Drugs: Ethinylestradiol/Gestodene (BAY86-5016)
7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen

Treatment: Drugs: Ethinylestradiol/Gestodene (BAY86-5016)
7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Occurrence of pregnancy
Timepoint [1] 0 0
13 treatment cycles each consisting of 28 days and follow-up period of 14 days
Primary outcome [2] 0 0
Occurrence of pregnancy
Timepoint [2] 0 0
13 treatment cycles each consisting of 28 days and follow-up period of 14 days
Secondary outcome [1] 0 0
Cervical smear
Timepoint [1] 0 0
13 treatment cycles each consisting of 28 days
Secondary outcome [2] 0 0
Adverse events
Timepoint [2] 0 0
13 treatment cycles each consisting of 28 days
Secondary outcome [3] 0 0
Bleeding pattern and cycle control
Timepoint [3] 0 0
13 treatment cycles each consisting of 28 days
Secondary outcome [4] 0 0
Cervical smear
Timepoint [4] 0 0
13 treatment cycles each consisting of 28 days
Secondary outcome [5] 0 0
Adverse events
Timepoint [5] 0 0
13 treatment cycles each consisting of 28 days
Secondary outcome [6] 0 0
Bleeding pattern and cycle control
Timepoint [6] 0 0
13 treatment cycles each consisting of 28 days

Eligibility
Key inclusion criteria
- Requiring contraception

- Normal cervical smear

- Smokers not older than 30 years

- History of regular cyclic menstrual periods
Minimum age
18 Years
Maximum age
35 Years
Gender
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
- Ashfield
Recruitment hospital [2] 0 0
- Adelaide
Recruitment hospital [3] 0 0
- North Adelaide
Recruitment hospital [4] 0 0
- Clayton
Recruitment hospital [5] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
2031 - Ashfield
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
5006 - North Adelaide
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Ciudad Auton. de Buenos Aires
Country [3] 0 0
Argentina
State/province [3] 0 0
Santa Fe
Country [4] 0 0
Chile
State/province [4] 0 0
Araucanía
Country [5] 0 0
Chile
State/province [5] 0 0
Santiago
Country [6] 0 0
Chile
State/province [6] 0 0
Temuco
Country [7] 0 0
France
State/province [7] 0 0
Biarritz
Country [8] 0 0
France
State/province [8] 0 0
Montargis
Country [9] 0 0
France
State/province [9] 0 0
Nimes
Country [10] 0 0
France
State/province [10] 0 0
Quetigny
Country [11] 0 0
France
State/province [11] 0 0
REIMS Cedex
Country [12] 0 0
France
State/province [12] 0 0
Saint Germain En Laye
Country [13] 0 0
France
State/province [13] 0 0
Toulouse
Country [14] 0 0
Germany
State/province [14] 0 0
Hessen
Country [15] 0 0
Germany
State/province [15] 0 0
Nordrhein-Westfalen
Country [16] 0 0
Germany
State/province [16] 0 0
Sachsen-Anhalt
Country [17] 0 0
Germany
State/province [17] 0 0
Sachsen
Country [18] 0 0
Germany
State/province [18] 0 0
Thüringen
Country [19] 0 0
Germany
State/province [19] 0 0
Berlin
Country [20] 0 0
Italy
State/province [20] 0 0
Brindisi
Country [21] 0 0
Italy
State/province [21] 0 0
Bologna
Country [22] 0 0
Italy
State/province [22] 0 0
Cagliari
Country [23] 0 0
Italy
State/province [23] 0 0
Catanzaro
Country [24] 0 0
Italy
State/province [24] 0 0
Firenze
Country [25] 0 0
Italy
State/province [25] 0 0
Modena
Country [26] 0 0
Italy
State/province [26] 0 0
Palermo
Country [27] 0 0
Italy
State/province [27] 0 0
Pavia
Country [28] 0 0
Italy
State/province [28] 0 0
Perugia
Country [29] 0 0
Italy
State/province [29] 0 0
Pisa
Country [30] 0 0
Italy
State/province [30] 0 0
Siena
Country [31] 0 0
Mexico
State/province [31] 0 0
Coahuila
Country [32] 0 0
Mexico
State/province [32] 0 0
Chihuahua
Country [33] 0 0
Mexico
State/province [33] 0 0
Mexico D.F.
Country [34] 0 0
Mexico
State/province [34] 0 0
México D.F.
Country [35] 0 0
Mexico
State/province [35] 0 0
México, D.F.
Country [36] 0 0
Mexico
State/province [36] 0 0
San Luis Potosí
Country [37] 0 0
Spain
State/province [37] 0 0
Cádiz
Country [38] 0 0
Spain
State/province [38] 0 0
Pontevedra
Country [39] 0 0
Spain
State/province [39] 0 0
Sevilla
Country [40] 0 0
Spain
State/province [40] 0 0
Vitoria
Country [41] 0 0
Spain
State/province [41] 0 0
Barcelona
Country [42] 0 0
Spain
State/province [42] 0 0
Lugo
Country [43] 0 0
Spain
State/province [43] 0 0
Pamplona
Country [44] 0 0
Spain
State/province [44] 0 0
Zaragoza

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The aim of the present study is to prove efficacy and safety of a new contraceptive patch.
Trial website
https://clinicaltrials.gov/show/NCT00914693
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications