Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT02841202
Status:
COMPLETED
Last Update Posted:
2017-08-21
First Post:
2016-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Oral Contraceptive Pills On Eyes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-08-24', 'releaseDate': '2020-08-10'}, {'resetDate': '2020-09-18', 'releaseDate': '2020-08-27'}], 'estimatedResultsFirstSubmitDate': '2020-08-10'}}, 'interventionBrowseModule': {'meshes': [{'id': 'C534342', 'term': 'drospirenone and ethinyl estradiol combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-16', 'studyFirstSubmitDate': '2016-07-14', 'studyFirstSubmitQcDate': '2016-07-19', 'lastUpdatePostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events on Eyes That Are Related to Treatment', 'timeFrame': 'one year'}]}, 'conditionsModule': {'keywords': ['optical coherence tomography', 'oral contraceptive pills'], 'conditions': ['Adverse Effect of Oral Contraceptives, Subsequent Encounter']}, 'descriptionModule': {'briefSummary': 'The investigators aimed to evaluate the effect of oral contraceptive pills(OCP) on macula, retinal nerve fiber layer and choroid thickness by using Optical Coherence Tomography (OCT). The present clinical study is the first research reported in the literature which is investigating the posterior ocular segment changes in women using OCP by using OCT.', 'detailedDescription': 'Spectral-domain optical coherence tomography (OCT) which is used to evaluate retina both qualitatively and qualitatively is a non invasive process. And also OCT makes it possible to perform retinal exams repeatedly without eye drops and dilatation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All the participants in the study group were Caucasian origin and the ages of them ranged from 18 to 48 in the reproductive period\n\nExclusion Criteria:\n\n* None of the women in the study was pregnant. Women who reported histories of any medical problems such as thyroid disorders, hypertension, thromboembolic disease, diabetes mellitus, cardiovascular events, Cushing disease, positive malignancy, congenital adrenal hyperplasia, liver disease, psychotic disorders and neither did they use antidepressants nor steroidal hormone drugs and mood stabilizers (lithium, valproic acid, cocaine, antiandrogens, and insulin sensitizers, etc) were excluded from the study. Subjects were also excluded if they used caffeine or tobacco. The investigators also excluded from the study those women who had ocular surgery, ocular trauma or any ocular diseases such as glaucoma, cystoid macular edema, macular degeneration, optic atrophy, intraocular pressure 421 mmHg, cataract, best corrected visual acuity worse than 20/30, high spherical4± 3 dioptre or cylindrical42 dioptre refractive errors and uveitis at the time of OCT measurement.'}, 'identificationModule': {'nctId': 'NCT02841202', 'briefTitle': 'The Effect of Oral Contraceptive Pills On Eyes', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kayseri Education and Research Hospital'}, 'officialTitle': 'The Effect of Oral Contraceptive Pills On Macula, Retinal Nerve Fiber Layer and Choroid Thickness', 'orgStudyIdInfo': {'id': '2013/65'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'oral contraceptive pills group', 'description': 'healthy women using oral contraceptive pills for only contraception for more than one year was called OCP group', 'interventionNames': ['Drug: oral contraceptive pills']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'The second group was called control group consisting 20 healthy women and using no drug'}], 'interventions': [{'name': 'oral contraceptive pills', 'type': 'DRUG', 'otherNames': ['yasmin'], 'armGroupLabels': ['oral contraceptive pills group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'YUSUF MADENDAG', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kayseri Education and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kayseri Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'obstetrics and gynecology', 'investigatorFullName': 'Yusuf MADENDAG', 'investigatorAffiliation': 'Kayseri Education and Research Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-08-10', 'type': 'RELEASE'}, {'date': '2020-08-24', 'type': 'RESET'}, {'date': '2020-08-27', 'type': 'RELEASE'}, {'date': '2020-09-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Yusuf MADENDAG, obstetrics and gynecology, Kayseri Education and Research Hospital'}}}}