Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-29 @ 12:59 PM
Study NCT ID:
NCT00710606
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2008-07-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Serum Contraceptive Hormone Levels Between Normal Weight and Obese Users of the NuvaRing®
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C516519', 'term': 'NuvaRing'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clw3@columbia.edu', 'phone': '212-305-4805', 'title': 'Carolyn Westhoff', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Obese Subjects', 'description': 'Obese subjects (BMI 30-39.9)', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Normal Weight Subjects', 'description': 'Normal weight subjects (BMI 19-24.9)', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'fractured pelvis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'venous thrombosis', 'notes': 'deep vein thrombosis of lower extremity during treatment. additional risk fact was long haul air travel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Serum Concentrations of Etonogestrel and Ethinyl Estradiol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Weight', 'description': 'Women of normal weight and obese received two contraceptive rings. During the second cycle of ring use, subject returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.'}, {'id': 'OG001', 'title': 'Obese', 'description': 'Women of normal weight and obese received two contraceptive rings. During the second cycle of ring use, subject returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.'}], 'classes': [{'title': 'Etonogesterel (ENG) Week 3', 'categories': [{'measurements': [{'value': '1275', 'groupId': 'OG000', 'lowerLimit': '1116', 'upperLimit': '1457'}, {'value': '1240', 'groupId': 'OG001', 'lowerLimit': '1041', 'upperLimit': '1477'}]}]}, {'title': 'Ethinyl Estradiol (EE) Week 3', 'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000', 'lowerLimit': '17.9', 'upperLimit': '26.6'}, {'value': '14.8', 'groupId': 'OG001', 'lowerLimit': '12.7', 'upperLimit': '17.3'}]}]}, {'title': 'Etonogesterel (ENG) Week 6', 'categories': [{'measurements': [{'value': '1063', 'groupId': 'OG000', 'lowerLimit': '730', 'upperLimit': '1548'}, {'value': '1096', 'groupId': 'OG001', 'lowerLimit': '730', 'upperLimit': '1646'}]}]}, {'title': 'Ethinyl Estradiol (EE) Week 6', 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '25.8'}, {'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '8.1', 'upperLimit': '19.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Measurements at Week 3 and Week 6 continuous ring use', 'description': 'Serum concentrations were obtained from thirty-seven women completed follow-up.', 'unitOfMeasure': 'ng/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '17 participants in each group was planned a priori to have 80% power to identify a one standard deviation difference in the mean serum levels of the contraceptive hormones. We enrolled 40 women, 2 withdrew prior to the study cycle. We excluded one woman due to removal of the CVR during the study cycle leaving 18 normal weight and 19 obese women.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving a Maximum Follicle Diameter > 13mm During the 3 Weeks of Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obese Subjects', 'description': 'Obese subjects (BMI 30-39.9)'}, {'id': 'OG001', 'title': 'Normal Weight Subjects', 'description': 'Normal weight subjects (BMI 19-24.9)'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'continuous ring use, an average of 3 weeks', 'description': 'Follicular development was minimal in both groups, with only five women achieving a maximum follicle diameter \\> 13mm at any time during the 3 weeks of follow-up (3 normal weight and 2 obese women).', 'unitOfMeasure': 'Participant w/follicular diameter >=13mm', 'reportingStatus': 'POSTED', 'populationDescription': '17 participants in each group was planned a priori to have 80% power to identify a one standard deviation difference in the mean serum levels of the contraceptive hormones. We enrolled 40 women, 2 withdrew prior to the study cycle. We excluded one woman due to removal of the CVR during the study cycle leaving 18 normal weight and 19 obese women.'}, {'type': 'SECONDARY', 'title': 'Mean Endometrial Proliferation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obese Subjects', 'description': 'Obese subjects (BMI 30-39.9)'}, {'id': 'OG001', 'title': 'Normal Weight Subjects', 'description': 'Normal weight subjects (BMI 19-24.9)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Transvaginal ultrasound measurements of endometrial proliferation will be completed over continuous ring use, an average of 3 weeks', 'description': 'The mean endometrial proliferation from week 1, week 2 and week3', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '17 participants in each group was planned a priori to have 80% power to identify a one standard deviation difference in the mean serum levels of the contraceptive hormones. We enrolled 40 women, 2 withdrew prior to the study cycle. We excluded one woman due to removal of the CVR during the study cycle leaving 18 normal weight and 19 obese women.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Obese Subjects', 'description': 'Obese subjects (BMI 30-39.9) received two contraceptive hormonal rings. During the second cycle of ring use, subjects returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.'}, {'id': 'FG001', 'title': 'Normal Weight Subjects', 'description': 'Normal weight subjects (BMI 19-24.9) received two contraceptive hormonal rings. During the second cycle of ring use, subjects returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Subjects were enrolled during the months of June-September 2008.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Obese Subjects', 'description': 'Obese subjects (BMI 30-39.9)'}, {'id': 'BG001', 'title': 'Normal Weight Subjects', 'description': 'Normal weight subjects (BMI 19-24.9)'}, {'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': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', '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': '24.5', 'spread': '3.2', 'groupId': 'BG000'}, {'value': '26.0', 'spread': '3.6', 'groupId': 'BG001'}, {'value': '25.8', 'spread': '3.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', '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': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-14', 'studyFirstSubmitDate': '2008-07-01', 'resultsFirstSubmitDate': '2013-08-22', 'studyFirstSubmitQcDate': '2008-07-03', 'lastUpdatePostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-14', 'studyFirstPostDateStruct': {'date': '2008-07-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Serum Concentrations of Etonogestrel and Ethinyl Estradiol', 'timeFrame': 'Measurements at Week 3 and Week 6 continuous ring use', 'description': 'Serum concentrations were obtained from thirty-seven women completed follow-up.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Achieving a Maximum Follicle Diameter > 13mm During the 3 Weeks of Follow-up', 'timeFrame': 'continuous ring use, an average of 3 weeks', 'description': 'Follicular development was minimal in both groups, with only five women achieving a maximum follicle diameter \\> 13mm at any time during the 3 weeks of follow-up (3 normal weight and 2 obese women).'}, {'measure': 'Mean Endometrial Proliferation', 'timeFrame': 'Transvaginal ultrasound measurements of endometrial proliferation will be completed over continuous ring use, an average of 3 weeks', 'description': 'The mean endometrial proliferation from week 1, week 2 and week3'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['contraceptive ring', 'obesity', 'pharmacokinetics', 'pharmacodynamics', 'Pharmacokinetics of the contraceptive ring in obese women.'], 'conditions': ['Pharmacokinetics']}, 'referencesModule': {'references': [{'pmid': '8536454', 'type': 'BACKGROUND', 'citation': 'Gu S, Sivin I, Du M, Zhang L, Ying L, Meng F, Wu S, Wang P, Gao Y, He X, et al. Effectiveness of Norplant implants through seven years: a large-scale study in China. Contraception. 1995 Aug;52(2):99-103. doi: 10.1016/s0010-7824(95)00141-7.'}, {'pmid': '9437561', 'type': 'BACKGROUND', 'citation': 'Sivin I, Lahteenmaki P, Mishell DR Jr, Alvarez F, Diaz S, Ranta S, Grozinger C, Lacarra M, Brache V, Pavez M, Nash H, Stern J. First week drug concentrations in women with levonorgestrel rod or Norplant capsule implants. Contraception. 1997 Nov;56(5):317-21. doi: 10.1016/s0010-7824(97)00153-4.'}, {'pmid': '11535213', 'type': 'BACKGROUND', 'citation': 'Sivin I, Wan L, Ranta S, Alvarez F, Brache V, Mishell DR Jr, Darney P, Biswas A, Diaz S, Kiriwat O, Anant MP, Klaisle C, Pavez M, Schechter J. Levonorgestrel concentrations during 7 years of continuous use of Jadelle contraceptive implants. Contraception. 2001 Jul;64(1):43-9. doi: 10.1016/s0010-7824(01)00226-8.'}, {'pmid': '11704172', 'type': 'BACKGROUND', 'citation': 'Smallwood GH, Meador ML, Lenihan JP, Shangold GA, Fisher AC, Creasy GW; ORTHO EVRA/EVRA 002 Study Group. Efficacy and safety of a transdermal contraceptive system. Obstet Gynecol. 2001 Nov;98(5 Pt 1):799-805. doi: 10.1016/s0029-7844(01)01534-4.'}, {'type': 'BACKGROUND', 'citation': "Westhoff, C. Higher body weight does not affect NuvaRing's efficacy. Obstet Gynecol 2005; 104: 56S."}, {'pmid': '11849631', 'type': 'BACKGROUND', 'citation': 'Zieman M, Guillebaud J, Weisberg E, Shangold GA, Fisher AC, Creasy GW. Contraceptive efficacy and cycle control with the Ortho Evra/Evra transdermal system: the analysis of pooled data. Fertil Steril. 2002 Feb;77(2 Suppl 2):S13-8. doi: 10.1016/s0015-0282(01)03275-7.'}]}, 'descriptionModule': {'briefSummary': 'There are over 60 million women of reproductive age in the U.S. and a majority of these women qualify as overweight or obese. Evidence suggests that there is an association between increased body weight and decreased contraceptive efficacy. Studies with the combined hormonal contraceptive patch (Evra®) and the subdermal contraceptive implant (Norplant®) demonstrate higher failure rates in heavier versus lighter women.\n\nWeight related differences in the effectiveness of NuvaRing® need further study. A single secondary analysis of pooled data from Phase III clinical trials of NuvaRing® noted no difference in pregnancy rates among women in the highest weight decile (\\>166#) versus the rest of the study population using the ring. (Westhoff, 2005) The finding of no difference, however, was influenced by too few obese subjects in the analysis which contributed to wide confidence limits. Additional studies are needed to explore how well the contraceptive ring functions to maintain effective serum steroid concentrations to suppress ovarian activity in obese women.\n\nThis investigation focused on evaluating mean serum concentrations of hormones released in obese and normal weight women using the NuvaRing® . This study was a prospective clinical trial. Normal weight women are defined as women with a BMI 19-24.9 and obese women are those with a BMI 30-39.9. We recruited forty adult women interested in initiating the combined hormonal contraceptive ring to two months of use to complete analysis of at least 34 subjects (17 normal weight, 17 obese). We compared mean serum concentrations of ethinyl estradiol (E2) and etonogestrel (ENG) along with additional markers for ovarian suppression. These markers included sonographic evidence of follicular development and ovulation as well as circulating E2 levels which strongly correlate with follicular development and endometrial proliferation during the second month of NuvaRing® use. Assessment of these parameters will translated to understanding contraceptive-mediated suppression of ovarian function in these two groups. Subjects also logged patterns of ring use and bleeding patterns during the study period.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-35 yo\n* Meet BMI requirements\n* Weight stable\n* English speaking\n* Desire contraception\n* History of regular menses with normal uterus and ovaries\n* Medically eligible for combined hormonal contraception\n* Tolerates phlebotomy/TVS\n\nExclusion Criteria:\n\n* Exclusion:\n* Heavy smokers\n* Users of medications that alter hormone levels'}, 'identificationModule': {'nctId': 'NCT00710606', 'briefTitle': 'Comparison of Serum Contraceptive Hormone Levels Between Normal Weight and Obese Users of the NuvaRing®', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Comparison of Serum Contraceptive Hormone Levels Between Normal Weight and Obese Users of the NuvaRing®', 'orgStudyIdInfo': {'id': 'AAAC8127'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1- Obese Women /Nuvaring', 'description': 'Obese subjects (BMI 30-39.9)received two contraceptive hormonal rings. During the second cycle of ring use, subjects returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.', 'interventionNames': ['Drug: NuvaRing']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2- Normal Weight / Nuvaring', 'description': 'Normal weight subjects (BMI 19-24.9) received two contraceptive hormonal rings. During the second cycle of ring use, subjects returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.', 'interventionNames': ['Drug: NuvaRing']}], 'interventions': [{'name': 'NuvaRing', 'type': 'DRUG', 'description': 'Obese subjects (BMI 30-39.9) will receive two contraceptive hormonal rings. During the second cycle of ring use, subjects will return to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.', 'armGroupLabels': ['1- Obese Women /Nuvaring']}, {'name': 'NuvaRing', 'type': 'DRUG', 'description': 'Normal weight subjects will also receive two contraceptive hormonal rings. During the second cycle of ring use, subjects will return to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.', 'armGroupLabels': ['2- Normal Weight / Nuvaring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Division of Family Planning and Preventive Services', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Carolyn Westhoff, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Organon', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Family Planning and Preventive Services Division', 'investigatorFullName': 'Carolyn L. Westhoff', 'investigatorAffiliation': 'Columbia University'}}}}