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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00914693




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

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
Condition category
Condition code

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

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
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
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

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
Sex
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
1/04/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2011
Sample size
Target
Accrual to date
Final
1694
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00914693