Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-01-01 @ 6:58 PM
Study NCT ID:
NCT00914693
Status:
COMPLETED
Last Update Posted:
2014-12-05
First Post:
2009-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EU/LA Pearl Index Study - Transdermal Contraceptive Patch
Sponsor:
Organization:
Raw JSON
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days'}], 'primaryOutcomes': [{'measure': 'Occurrence of pregnancy', 'timeFrame': '13 treatment cycles each consisting of 28 days and follow-up period of 14 days'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fertility control', 'Contraception'], 'conditions': ['Contraception']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu', 'label': 'Click here and search for Bayer Product information provided by EMA'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to prove efficacy and safety of a new contraceptive patch.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Requiring contraception\n* Normal cervical smear\n* Smokers not older than 30 years\n* History of regular cyclic menstrual periods\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Obesity (BMI\\> 30 kg/m2\n* Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape\n* Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)\n* Use of other contraceptive methods than study medication'}, 'identificationModule': {'nctId': 'NCT00914693', 'briefTitle': 'EU/LA Pearl Index Study - Transdermal Contraceptive Patch', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': '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. 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