Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-02-28 @ 5:28 AM
Study NCT ID:
NCT00612508
Status:
COMPLETED
Last Update Posted:
2012-11-08
First Post:
2008-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hormonal Contraception and Vaginal Health
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003268', 'term': 'Contraception Behavior'}], 'ancestors': [{'id': 'D043762', 'term': 'Reproductive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017135', 'term': 'Desogestrel'}, {'id': 'D004997', 'term': 'Ethinyl Estradiol'}, {'id': 'C516519', 'term': 'NuvaRing'}, {'id': 'C044815', 'term': 'etonogestrel'}], 'ancestors': [{'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D009651', 'term': 'Norpregnatrienes'}, {'id': 'D042782', 'term': 'Estrogenic Steroids, Alkylated'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'whru@ohsu.edu', 'phone': '503-494-3666', 'title': 'Oregon Health & Science University', 'organization': "Women's Health Research Unit"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Did not fully recruit; small number of subject'}}, 'adverseEventsModule': {'timeFrame': 'Every 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Desogen', 'description': 'oral contraceptive', 'otherNumAtRisk': 7, 'otherNumAffected': 1, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'NuvaRing', 'description': 'intravaginal contraception', 'otherNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bleeding from vagina', 'notes': 'Minor bleeding and pain associated with biopsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SNOMED-CT 289530006'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Desogen', 'description': 'oral contraceptive = P (pill)'}, {'id': 'OG001', 'title': 'NuvaRing', 'description': 'intravaginal contraception = R (ring)'}], 'classes': [{'title': 'mean difference at 84 days', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.005', 'spread': '0.048', 'groupId': 'OG001'}]}]}, {'title': 'mean difference at 168 days', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '.007', 'spread': '0.028', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 84 days, 168 days', 'description': 'Histologic evalation of vaginal sections was performed to measured and record the absolute thickness of the vaginal epithelium. Baseline findings were compared to biopsies after three and six cycles of treatment. Mean values were compared using T-test for paired data for baseline and 84 days, and baseline and 168 days', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 14 subjects (7 R, 7 P) were randomized and had an initial biopsy; 11 (6 R, 5 P) returned for a biopsy at 3rd cycle (84 days), and 6 (3 R, 4 P) 6th cycle (168 days).\n\nThe analysis used a paired T test comparing the baseline mean to the mean as the end of the 3rd cylce (e.g. 84 days) and the 6th cycle (168 days)'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Contraceptive', 'description': 'Desogen (ethinyl estradiol \\& desogestrel) = P (pill)'}, {'id': 'OG001', 'title': 'Intravaginal Ring Contraceptive', 'description': 'nuvaring (ethinyl estradiol \\& desogestrel) = R (ring)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'over 168 days', 'description': 'Self-reported treatment-related and serious adverse events', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects that were enrolled were assessed for adverse events at each study visit. Measure is number of participants with event'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Desogen', 'description': 'oral contraceptive'}, {'id': 'FG001', 'title': 'NuvaRing', 'description': 'intravaginal contraception'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '5 desogen users returned for the 84 day biopsy', 'groupId': 'FG000', 'numSubjects': '4'}, {'comment': '6 nuvaring users returned for the 84 day biopsy', 'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Desogen', 'description': 'oral contraceptive'}, {'id': 'BG001', 'title': 'NuvaRing', 'description': 'intravaginal contraception'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28', 'spread': '4', 'groupId': 'BG000'}, {'value': '24', 'spread': '3.4', 'groupId': 'BG001'}, {'value': '25.8', 'spread': '4.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-09', 'studyFirstSubmitDate': '2008-01-29', 'resultsFirstSubmitDate': '2010-12-16', 'studyFirstSubmitQcDate': '2008-01-29', 'lastUpdatePostDateStruct': {'date': '2012-11-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-10-09', 'studyFirstPostDateStruct': {'date': '2008-02-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported.', 'timeFrame': 'baseline, 84 days, 168 days', 'description': 'Histologic evalation of vaginal sections was performed to measured and record the absolute thickness of the vaginal epithelium. Baseline findings were compared to biopsies after three and six cycles of treatment. Mean values were compared using T-test for paired data for baseline and 84 days, and baseline and 168 days'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'over 168 days', 'description': 'Self-reported treatment-related and serious adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['contraception', 'NuvaRing', 'Desogen', 'vaginal biopsy'], 'conditions': ['Contraceptive Usage', 'Vaginal Epithelial Disruption']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ohsuwomenshealth.com/research/index.html', 'label': "(Women's Health Research Unit website)"}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to help determine if the route by which women receive hormonal contraception causes different changes to occur in the lining of the vagina. The investigators plan to compare an oral route (taking birth control pills) with a vaginal route (using a vaginal ring).', 'detailedDescription': 'The investigators intend to conduct a prospective, randomized study at Oregon Health and Science University. This study will be conducted over six 28-day cycles. Subjects enrolled in the study will undergo baseline vaginal biopsy and then be randomized to receive either intravaginal ethinyl estradiol and etonogestrel (NuvaRing®) or oral ethinyl estradiol and desogestrel (Desogen®). Repeat vaginal biopsies will be obtained after three and six months of exposure to either oral or intravaginal hormonal contraception. These will be analyzed to measure the thickness of the vaginal epithelium and to quantify the presence of Langerhans cell, macrophages, T-lymphocytes and dendritic cells.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* 18-35 years\n* In general good health\n* With regular menses (every 28-32 days)\n* Seeking contraception and willing to use a hormonal method for at least 6 months\n\nExclusion Criteria:\n\n* Current or recent (within the past 8 weeks) vaginitis or pelvic inflammatory disease\n* History of recurrent vaginitis (\\> 2 episodes in one year, any type)\n* Pregnancy\n* Recent use of hormonal contraceptives\n* Depot medroxyprogesterone: 6 months\n* Progestin implants: 3 months\n* Oral contraceptives: 3 months\n* Hormone impregnated IUD: 3 months\n* Contraindications to use of oral contraceptive pills or vaginal ring\n* History of deep vein thrombosis\n* Known coagulopathy or thrombophilia\n* Unexplained vaginal bleeding\n* Uncontrolled hypertension\n* Diabetes with vascular changes\n* Present or history of hepatic disease or liver tumors\n* Migraines with neurologic changes\n* Myocardial infection\n* Pulmonary embolus\n* Stroke\n* Breast cancer\n* Hypersensitivity or allergy to hormonal contraception\n* Heavy Smoking ( ≥ 15 cigarettes per day)'}, 'identificationModule': {'nctId': 'NCT00612508', 'briefTitle': 'Hormonal Contraception and Vaginal Health', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'The Effects of Oral vs. Intravaginal Hormonal Contraception on Vaginal Health', 'orgStudyIdInfo': {'id': 'OHSU RES 2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Desogen', 'description': 'Drug: ethinyl estradiol and desogestrel\n\n1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol; secen inactive pills every 28 days.\n\nSubjects receive baseline vaginal biopsy, followed by treatment with the OC for six cycles and repeat biopsy at 3 and after 6 cycles', 'interventionNames': ['Drug: Desogen (ethinyl estradiol and desogestrel)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NuvaRing', 'description': 'Intravaginal Contraception\n\nethinyl estradiol (0.15 mg/d) and etonogestrel (0.12 mg/d) Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring\n\nSubjects had baseline vaginal biopsy followed by 6 cycles of ring use and repeat biopsy at 3 and after 6 cycles', 'interventionNames': ['Drug: NuvaRing (ethinyl estradiol and etonogestrel)']}], 'interventions': [{'name': 'Desogen (ethinyl estradiol and desogestrel)', 'type': 'DRUG', 'otherNames': ['Desogen®'], 'description': '1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol', 'armGroupLabels': ['Desogen']}, {'name': 'NuvaRing (ethinyl estradiol and etonogestrel)', 'type': 'DRUG', 'otherNames': ['NuvaRing®'], 'description': 'Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring', 'armGroupLabels': ['NuvaRing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Jeffrey T Jensen, MD., MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oregon Clinical and Translational Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD MPH', 'investigatorFullName': 'Jeffrey Jensen', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}