Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-27 @ 7:36 AM
Study NCT ID:
NCT00369967
Status:
TERMINATED
Last Update Posted:
2016-07-22
First Post:
2006-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Quick Start Initiation of the Contraceptive Vaginal Ring in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C516519', 'term': 'NuvaRing'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nkarjane@mcvh-vcu.edu', 'phone': '804-828-8614', 'title': 'Nicole Karjane', 'organization': 'VCUHS'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Traditional Start', 'description': 'NuvaRing: Initiation of NuvaRing for contraception per package insert', 'otherNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Quick Start', 'description': 'NuvaRing: Initiation of NuvaRing for contraception on day of enrollment', 'otherNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Continuation With the Contraceptive Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quick Start', 'description': 'Start method day of enrollment\n\nNuvaRing: Initiation of NuvaRing for contraception'}, {'id': 'OG001', 'title': 'Traditional Start', 'description': 'NuvaRing: Initiation of NuvaRing for contraception'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Participants reporting continuation with contraceptive method at 3 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number using method at 3 months'}, {'type': 'PRIMARY', 'title': 'Method Continuation at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Traditional Start', 'description': 'NuvaRing: Initiation of NuvaRing for contraception per package insert'}, {'id': 'OG001', 'title': 'Quick Start', 'description': 'NuvaRing: Initiation of NuvaRing for contraception on day of enrollment'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Participants reporting continuation of method at 6 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled'}, {'type': 'PRIMARY', 'title': 'Method Continuation at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quick Start', 'description': 'NuvaRing: Initiation of NuvaRing for contraception on day of enrollment'}, {'id': 'OG001', 'title': 'Traditional Start', 'description': 'NuvaRing: Initiation of NuvaRing for contraception per package insert'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Participants reporting continuation with method at 12 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled'}, {'type': 'SECONDARY', 'title': 'Pregnancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quick Start', 'description': 'NuvaRing: Initiation of NuvaRing for contraception on day of enrollment'}, {'id': 'OG001', 'title': 'Traditional Start', 'description': 'NuvaRing: Initiation of NuvaRing for contraception per package insert'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3,6, and 12 mo', 'description': 'Number of pregnancies reported', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were no reported pregnancies during the study period'}, {'type': 'SECONDARY', 'title': 'Bleeding Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quick Start', 'description': 'NuvaRing: Initiation of NuvaRing for contraception on day of enrollment'}, {'id': 'OG001', 'title': 'Traditional Start', 'description': 'NuvaRing: Initiation of NuvaRing for contraception per package insert'}], 'timeFrame': '3, 6, and 12 months', 'reportingStatus': 'POSTED', 'populationDescription': 'None of the participants returned their menstrual calendars to assess this outcome'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quick Start', 'description': 'NuvaRing: Initiation of NuvaRing for contraception on day of enrollment'}, {'id': 'OG001', 'title': 'Traditional Start', 'description': 'NuvaRing: Initiation of NuvaRing for contraception per package insert'}], 'timeFrame': '3, 6, and 12 months', 'description': 'Rating of patient satisfaction with method', 'reportingStatus': 'POSTED', 'populationDescription': 'None of the participants returned their satisfaction survey'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Traditional Start', 'description': 'NuvaRing: Initiation of NuvaRing for contraception per package insert'}, {'id': 'FG001', 'title': 'Quick Start', 'description': 'NuvaRing: Initiation of NuvaRing for contraception on day of enrollment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Traditional Start', 'description': 'NuvaRing: Initiation of NuvaRing for contraception per package insert'}, {'id': 'BG001', 'title': 'Quick Start', 'description': 'NuvaRing: Initiation of NuvaRing for contraception on day of enrollment'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '37', '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': '19', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '18', 'spread': '2.1', 'groupId': 'BG001'}, {'value': '18', 'spread': '1.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'all female participants', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'whyStopped': 'difficulty in subject recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-10', 'studyFirstSubmitDate': '2006-08-29', 'resultsFirstSubmitDate': '2015-12-10', 'studyFirstSubmitQcDate': '2006-08-29', 'lastUpdatePostDateStruct': {'date': '2016-07-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-06-10', 'studyFirstPostDateStruct': {'date': '2006-08-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Continuation With the Contraceptive Method', 'timeFrame': '3 months', 'description': 'Participants reporting continuation with contraceptive method at 3 months'}, {'measure': 'Method Continuation at 6 Months', 'timeFrame': '6 months', 'description': 'Participants reporting continuation of method at 6 months'}, {'measure': 'Method Continuation at 12 Months', 'timeFrame': '12 months', 'description': 'Participants reporting continuation with method at 12 months'}], 'secondaryOutcomes': [{'measure': 'Pregnancy', 'timeFrame': '3,6, and 12 mo', 'description': 'Number of pregnancies reported'}, {'measure': 'Bleeding Profile', 'timeFrame': '3, 6, and 12 months'}, {'measure': 'Patient Satisfaction', 'timeFrame': '3, 6, and 12 months', 'description': 'Rating of patient satisfaction with method'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contraception', 'Adolescents', 'Contraceptive vaginal ring', 'Quick start'], 'conditions': ['Contraception Desired']}, 'referencesModule': {'references': [{'pmid': '10326194', 'type': 'BACKGROUND', 'citation': 'Zibners A, Cromer BA, Hayes J. Comparison of continuation rates for hormonal contraception among adolescents. J Pediatr Adolesc Gynecol. 1999 May;12(2):90-4. doi: 10.1016/s1083-3188(00)86633-4.'}, {'pmid': '9988830', 'type': 'BACKGROUND', 'citation': 'Rosenberg M, Waugh MS. Causes and consequences of oral contraceptive noncompliance. Am J Obstet Gynecol. 1999 Feb;180(2 Pt 2):276-9. doi: 10.1016/s0002-9378(99)70718-0.'}, {'pmid': '16102549', 'type': 'BACKGROUND', 'citation': 'van den Heuvel MW, van Bragt AJ, Alnabawy AK, Kaptein MC. Comparison of ethinylestradiol pharmacokinetics in three hormonal contraceptive formulations: the vaginal ring, the transdermal patch and an oral contraceptive. Contraception. 2005 Sep;72(3):168-74. doi: 10.1016/j.contraception.2005.03.005.'}, {'pmid': '11684110', 'type': 'BACKGROUND', 'citation': 'Rivera R, Cabral de Mello M, Johnson SL, Chandra-Mouli V. Contraception for adolescents: social, clinical and service-delivery considerations. Int J Gynaecol Obstet. 2001 Nov;75(2):149-63. doi: 10.1016/s0020-7292(01)00371-x.'}, {'pmid': '12618252', 'type': 'BACKGROUND', 'citation': 'Novak A, de la Loge C, Abetz L, van der Meulen EA. The combined contraceptive vaginal ring, NuvaRing: an international study of user acceptability. Contraception. 2003 Mar;67(3):187-94. doi: 10.1016/s0010-7824(02)00514-0.'}, {'pmid': '15722066', 'type': 'BACKGROUND', 'citation': 'Oddsson K, Leifels-Fischer B, de Melo NR, Wiel-Masson D, Benedetto C, Verhoeven CH, Dieben TO. Efficacy and safety of a contraceptive vaginal ring (NuvaRing) compared with a combined oral contraceptive: a 1-year randomized trial. Contraception. 2005 Mar;71(3):176-82. doi: 10.1016/j.contraception.2004.09.001.'}, {'pmid': '12384200', 'type': 'BACKGROUND', 'citation': 'Westhoff C, Kerns J, Morroni C, Cushman LF, Tiezzi L, Murphy PA. Quick start: novel oral contraceptive initiation method. Contraception. 2002 Sep;66(3):141-5. doi: 10.1016/s0010-7824(02)00351-7.'}, {'pmid': '12204779', 'type': 'BACKGROUND', 'citation': 'Lara-Torre E, Schroeder B. Adolescent compliance and side effects with Quick Start initiation of oral contraceptive pills. Contraception. 2002 Aug;66(2):81-5. doi: 10.1016/s0010-7824(02)00326-8.'}, {'pmid': '12568841', 'type': 'BACKGROUND', 'citation': 'Westhoff C, Morroni C, Kerns J, Murphy PA. Bleeding patterns after immediate vs. conventional oral contraceptive initiation: a randomized, controlled trial. Fertil Steril. 2003 Feb;79(2):322-9. doi: 10.1016/s0015-0282(02)04680-0.'}, {'pmid': '15994622', 'type': 'BACKGROUND', 'citation': 'Westhoff C, Osborne LM, Schafer JE, Morroni C. Bleeding patterns after immediate initiation of an oral compared with a vaginal hormonal contraceptive. Obstet Gynecol. 2005 Jul;106(1):89-96. doi: 10.1097/01.AOG.0000164483.13326.59.'}]}, 'descriptionModule': {'briefSummary': 'We hypothesize that using "quick start" initiation of the contraceptive vaginal ring in adolescents seeking birth control will improve compliance compared to traditional start. We will conduct a randomized controlled trial comparing "quick start" to traditional start initiation of the contraceptive vaginal ring in adolescents seeking birth control. The primary study outcome is method continuation at 3, 6, and 12 months. Secondary outcomes include abnormal bleeding, product satisfaction, and adverse events.', 'detailedDescription': 'Pregnancy prevention is an important aspect of adolescent healthcare. Adherence to a chosen contraception method is essential to its success. Adolescents are notoriously poor at complying with oral contraceptives (OCs), with continuation rates at one year as low as 12% (1). In those patients who continue their contraceptive method, our best data estimates that the average OC user misses three pills per cycle (2). Given the already highly fluctuant serum hormone levels in OC users (3), this leaves poorly compliant users at greater risk for unintended pregnancy.\n\nThe contraceptive vaginal ring is a reliable method of contraception and may be particularly useful in the adolescent population because of its simple monthly dosing schedule (4). It is a combined hormonal contraceptive containing etonogestrel (a progesterone) and ethinyl estradiol (an estrogen), which are released continuously at low levels. The vaginal ring has been shown to have comparable efficacy and tolerability to OCs (5), but does not require daily dosing due to its novel drug delivery system. Studies have shown high rates of acceptability and satisfaction with vaginal ring usage in adult and adolescent women and a high rate of continuation using a traditional start method (6).\n\nThe "quick start" method of initiating use of OCs has been found to improve continuation rates and overall method satisfaction compared to traditional start in large studies of adult women (7) and also in small studies of adolescents (8) without significantly affecting incidence of breakthrough bleeding or patient satisfaction (9). "Quick start" contraceptive vaginal ring has been studied in women aged 18-40 years and found to have a more favorable bleeding profile than "quick start" Ortho-Tricyclen Lo (10). This decreased incidence of altered bleeding may be a more favorable benefit of "quick start" contraceptive vaginal ring in the adolescent population as well.\n\nOne of the biggest obstacles to use of the contraceptive vaginal ring in clinical practice is having the patient overcome the idea of vaginally inserting the ring, especially in the adolescent population (11). It seems logical that initiating the vaginal ring in the office via the "quick start" method may improve patient acceptance and comfort with the method, thus improving continuation rates in these patients compared to traditional initiation.\n\nWe propose to perform a randomized controlled trial comparing "quick start" to traditional start NuvaRing in adolescents. Subjects meeting inclusion criteria will be randomized to either start the method in the office immediately or start the method within 5 days of her next menstrual period. Subjects will follow up at 3, 6, and 12 months, at which time we will assess continuation, bleeding patterns, pregnancy, and patient satisfaction.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: 1) female aged 15 through 21 presenting for contraception; 2) willing to use the NuvaRing as their contraceptive method; 3) English-speaking; 4) up to date on routine health maintenance screening (pap smear within 3 years of initiation of sexual intercourse and Gonorrhea/ Chlamydia testing yearly or with each new partner); and 5) able to read and understand the consent form.\n\nExclusion Criteria: 1) are pregnant; 2) have a contraindication to hormonal contraception; 3) are unwilling to use NuvaRing as their contraceptive method; 4) are currently using any hormonal contraceptive or have used one within past 2 months; 5) have used emergency contraception in the past 7 days; 6) have had unprotected intercourse in the past 10 days; 7) have untreated Gonorrhea or Chlamydia; or 8) are unable to give informed consent because of psychiatric or cognitive problems.'}, 'identificationModule': {'nctId': 'NCT00369967', 'briefTitle': 'Quick Start Initiation of the Contraceptive Vaginal Ring in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': '"Quick Start" Initiation of the Contraceptive Vaginal Ring in Adolescents: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '5120008FN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quick start', 'description': 'Start contraceptive method (NuvaRing) day of enrollment', 'interventionNames': ['Drug: NuvaRing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional start', 'description': 'Start contraceptive method (NuvaRing) after next menses (per package insert)', 'interventionNames': ['Drug: NuvaRing']}], 'interventions': [{'name': 'NuvaRing', 'type': 'DRUG', 'otherNames': ['contraceptive vaginal ring'], 'description': 'Initiation of NuvaRing for contraception', 'armGroupLabels': ['Quick start', 'Traditional start']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Nicole W Karjane, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not planned.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American College of Obstetricians and Gynecologists', 'class': 'OTHER'}, {'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}