Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-02-08 @ 1:03 PM
Study NCT ID:
NCT00653159
Status:
COMPLETED
Last Update Posted:
2023-02-23
First Post:
2008-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Maintaining Intrauterine Devices (IUDs) in Teens (MINT): A Randomization Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'swatson@health.bsd.uchicago.edu', 'phone': '773-834-2378', 'title': 'Dr. Sydeaka Watson, PhD', 'organization': 'The University of Chicago Department of Health Studies, Biostatistics Laboratory'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Paragard IUD [CuT380A]', 'description': 'Paragard intrauterine device (IUD), Copper T 380A', 'otherNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mirena IUD [LNG-IUS]', 'description': 'Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System', 'otherNumAtRisk': 12, 'otherNumAffected': 10, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anemia', 'notes': 'Disorder characterized by reduction in the amt of hemoglobin in 100 ml of blood. Signs/symptoms may include pallor of the skin and mucous membranes, shortness of breath, palpitations of the heart, soft systolic murmurs, lethargy, and fatigability.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Abdominal pain', 'notes': 'A disorder characterized by a sensation of marked discomfort in the abdominal region.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Bloating', 'notes': 'A disorder characterized by subject-reported feeling of uncomfortable fullness of the abdomen.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vomiting', 'notes': 'A disorder characterized by the reflexive act of ejecting the contents of the stomach through the mouth.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'notes': 'A disorder characterized by a queasy sensation and/or the urge to vomit.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fatigue', 'notes': 'A disorder characterized by a state of generalized weakness with a pronounced inability to summon sufficient energy to accomplish daily activities.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fever', 'notes': "A disorder characterized by elevation of the body's temperature above the upper limit of normal.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Leg pain', 'notes': 'Pain in the leg.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': "Abscess/infection of Bartholin's gland", 'notes': "Abscess/infection of Bartholin's gland", 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bacterial vaginosis', 'notes': 'Bacterial vaginosis is the name of a condition in women where the normal balance of bacteria in the vagina is disrupted and replaced by an overgrowth of certain bacteria. It is sometimes accompanied by discharge, odor, pain, itching, or burning.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Trichomoniasis', 'notes': 'Trichomoniasis (or "trich") is a very common sexually transmitted disease (STD) that is caused by infection with a protozoan parasite called Trichomonas vaginalis.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'notes': 'A disorder characterized by an infectious process involving the urinary tract, most commonly the bladder and the urethra', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Weight gain', 'notes': 'A finding characterized by an increase in overall body weight; for pediatrics, greater than the baseline growth curve.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headaches', 'notes': 'A disorder characterized by a sensation of marked discomfort in various parts of the head, not confined to the area of distribution of any nerve', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Libido decreased', 'notes': 'A disorder characterized by a decrease in sexual desire.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Psychiatric disorders - Other (Mood Swings)', 'notes': 'A mood swing is an extreme or rapid change in mood.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast swelling', 'notes': 'Swelling and tenderness of the breasts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irregular menstruation', 'notes': 'A disorder characterized by irregular cycle or duration of menses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Menorrhagia', 'notes': 'A disorder characterized by abnormally heavy vaginal bleeding during menses.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 5}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Menstrual pain', 'notes': 'Pain during menses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 5}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal discharge', 'notes': 'A disorder characterized by vaginal secretions. Mucus produced by the cervical glands is discharged from the vagina naturally, especially during the childbearing years.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vaginal inflammation', 'notes': 'A disorder characterized by inflammation involving the vagina. Symptoms may include redness, edema, marked discomfort and an increase in vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Acne', 'notes': 'Acne is a common human skin disease, characterized by areas of skin with seborrhea (scaly red skin), comedones (blackheads and whiteheads), papules (pinheads), pustules (pimples), nodules (large papules) and possibly scarring.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Retention Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paragard IUD [CuT380A]', 'description': 'Paragard intrauterine device (IUD), Copper T 380A'}, {'id': 'OG001', 'title': 'Mirena IUD [LNG-IUS]', 'description': 'Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4003', 'groupIds': ['OG000', 'OG001'], 'groupDescription': "Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject completed the final study visit at 6 months. Under the null hypothesis, study completion rates are similar for both IUD types.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Two-sided test'}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up)', 'unitOfMeasure': 'percentage of randomized subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'All study participants were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Heavy Bleeding Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paragard IUD [CuT380A]', 'description': 'Paragard intrauterine device (IUD), Copper T 380A'}, {'id': 'OG001', 'title': 'Mirena IUD [LNG-IUS]', 'description': 'Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4136', 'groupIds': ['OG000', 'OG001'], 'groupDescription': "Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject experienced heavy bleeding. Under the null hypothesis, heavy bleeding rates are similar for both IUD types.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Two-sided test'}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A.', 'unitOfMeasure': 'percentage of randomized subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'All study participants were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Pregnancy Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paragard IUD [CuT380A]', 'description': 'Paragard intrauterine device (IUD), Copper T 380A'}, {'id': 'OG001', 'title': 'Mirena IUD [LNG-IUS]', 'description': 'Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4783', 'groupIds': ['OG000', 'OG001'], 'groupDescription': "Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject became pregnant within 6 months of IUD insertion. Under the null hypothesis, pregnancy rates are similar for both IUD types.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Two-sided test'}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Proportion of subjects who became pregnant within 6 months of IUD insertion', 'unitOfMeasure': 'percentage of randomized subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'All study participants were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Expulsion Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paragard IUD [CuT380A]', 'description': 'Paragard intrauterine device (IUD), Copper T 380A'}, {'id': 'OG001', 'title': 'Mirena IUD [LNG-IUS]', 'description': 'Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2174', 'groupIds': ['OG000', 'OG001'], 'groupDescription': "Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject experienced expulsion of the IUD. Under the null hypothesis, expulsion rates are similar for both IUD types.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Two-sided test'}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Rates of partial or complete expulsion for teens randomized to the LNG-IUS or Copper T 380A. Patients experiencing partial expulsion had IUDs visible on speculum exam. Complete expulsion is characterized by complete evacuation of the IUD.', 'unitOfMeasure': 'percentage of randomized subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'All study participants were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Device Satisfaction Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paragard IUD [CuT380A]', 'description': 'Paragard intrauterine device (IUD), Copper T 380A'}, {'id': 'OG001', 'title': 'Mirena IUD [LNG-IUS]', 'description': 'Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Fisher\'s exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject reported being satisfied ("happy" or "very happy") at the 6 month study visit. Under the null hypothesis, satisfaction rates are similar for both IUD types.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Two-sided test'}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Satisfaction rate is the proportion of subjects who report being "happy" or "very happy" with their assigned intrauterine contraceptive method on the date of their 6 month study visit.', 'unitOfMeasure': 'percentage of subjects completing study', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects who were not lost to follow-up at 6 months were included in this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Paragard IUD [CuT380A]', 'description': 'Paragard intrauterine device (IUD), Copper T 380A'}, {'id': 'FG001', 'title': 'Mirena IUD [LNG-IUS]', 'description': 'Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This study was conducted within the Section of Family Planning in the Department of Obstetrics and Gynecology at The University of Chicago and within the Department of Family Medicine at the University of Illinois-Chicago. From December 2007 through June 2008, 37 adolescent females were approached regarding the study.', 'preAssignmentDetails': 'All of the 23 enrolled subjects were ultimately randomized to the treatment arms (12 to LNG-IUS and 11 to CuT380A).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Paragard IUD [CuT380A]', 'description': 'Paragard intrauterine device (IUD), Copper T 380A'}, {'id': 'BG001', 'title': 'Mirena IUD [LNG-IUS]', 'description': 'Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000', 'lowerLimit': '15', 'upperLimit': '18'}, {'value': '16.5', 'groupId': 'BG001', 'lowerLimit': '14', 'upperLimit': '18'}, {'value': '16.5', 'groupId': 'BG002', 'lowerLimit': '14', 'upperLimit': '18'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'title': '8th grade or less', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Current high school student', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'High school diploma/GED', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Some college/current college student', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Parous', 'classes': [{'title': 'Parous', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Nulliparous', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'A parous female participant has given birth one or more times. A female is nulliparous if she has never given birth.', 'unitOfMeasure': 'participants'}, {'title': 'Previous STI', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of participants who have previously tested positive for one or more of the following sexually transmitted infections (STI) during the screening visit: chlamydia, gonorrhea, trichomonas, and vaginal warts.', 'unitOfMeasure': 'participants'}, {'title': 'Presence of STI at screening visit', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of participants who tested positive for one or more of the following sexually transmitted infections (STI) during the screening visit: chlamydia, gonorrhea, trichomonas, and vaginal warts.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-21', 'studyFirstSubmitDate': '2008-04-01', 'resultsFirstSubmitDate': '2012-09-18', 'studyFirstSubmitQcDate': '2008-04-03', 'lastUpdatePostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-09-18', 'studyFirstPostDateStruct': {'date': '2008-04-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention Rate', 'timeFrame': '6 months', 'description': 'Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up)'}], 'secondaryOutcomes': [{'measure': 'Heavy Bleeding Rates', 'timeFrame': '6 months', 'description': 'Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A.'}, {'measure': 'Pregnancy Rates', 'timeFrame': '6 months', 'description': 'Proportion of subjects who became pregnant within 6 months of IUD insertion'}, {'measure': 'Expulsion Rates', 'timeFrame': '6 months', 'description': 'Rates of partial or complete expulsion for teens randomized to the LNG-IUS or Copper T 380A. Patients experiencing partial expulsion had IUDs visible on speculum exam. Complete expulsion is characterized by complete evacuation of the IUD.'}, {'measure': 'Device Satisfaction Rates', 'timeFrame': '6 months', 'description': 'Satisfaction rate is the proportion of subjects who report being "happy" or "very happy" with their assigned intrauterine contraceptive method on the date of their 6 month study visit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intrauterine device, contraception, unplanned pregnancy'], 'conditions': ['Contraception']}, 'descriptionModule': {'briefSummary': 'This is a pilot study to determine the feasibility for a randomized controlled trial of two forms of intrauterine contraception: the Levonorgestrel intrauterine system (LNG-IUS) and the Copper T 380A.', 'detailedDescription': 'Teenagers have the highest percentage of unintended pregnancies, and often struggle to comply with daily methods of contraception. The intrauterine device (IUD) provides safe, long-term protection and rates highly for patient satisfaction. It also does not require repeat prescriptions or clinic visits, making it a potentially attractive method among teens. However, in adolescent populations, there is both a lack of information about the IUD, as well as few studies that have examined the use of these devices. This study will examine whether a larger scale study on this topic is feasible. IT will address the feasibility of recruiting, consenting, screening, enrolling, randomizing, and retaining adolescents randomized to the LNG-IUS or Copper T 380a.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy, sexually active females age 14 to 18 who:\n\n* Are interested in long term, reversible contraception\n* Have regular menstrual cycles (21-35 days)\n* Are not planning a pregnancy within the next 6 months\n\nExclusion Criteria:\n\nSexually active females age over the age of 18 or who:\n\n* Are not interested in long term, reversible contraception\n* Do not have regular menstrual cycles (21-35 days)\n* Are planning a pregnancy within the next 6 months'}, 'identificationModule': {'nctId': 'NCT00653159', 'acronym': 'MINT', 'briefTitle': 'Maintaining Intrauterine Devices (IUDs) in Teens (MINT): A Randomization Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Intrauterine Contraception for Adolescents Aged 14 to 18: A Multi-center Randomized Controlled Feasibility Trial of Levonorgestrel-releasing Intrauterine System Compared to the Copper T 380A', 'orgStudyIdInfo': {'id': '15498A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mirena IUD [LNG-IUS]', 'description': "Participants in this arm had a Levonorgestrel-releasing intrauterine device (LNG-IUS), also known as the Mirena IUD, inserted within the first 5 days of the adolescent's menstrual cycle, at least 7 weeks after a vaginal or cesarean delivery or second-trimester abortion or at least 3 weeks after a first-trimester abortion. For participants who had used depot-medroxyprogesterone acetate, insertions occurred at least 6 months after the participant's last injection. Participants were blinded to the device type; however, investigators and research assistants were not.", 'interventionNames': ['Device: Levonorgestrel-releasing intrauterine device (LNG-IUS)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paragard IUD [Copper T380A]', 'description': "Participants in this arm had a Copper T380A intrauterine device (CuT380A), also known as the Paragard IUD, inserted within the first 5 days of the adolescent's menstrual cycle, at least 7 weeks after a vaginal or cesarean delivery or second-trimester abortion or at least 3 weeks after a first-trimester abortion. For participants who had used depot-medroxyprogesterone acetate, insertions occurred at least 6 months after the participant's last injection. Participants were blinded to the device type; however, investigators and research assistants were not.", 'interventionNames': ['Device: Copper T380A intrauterine device (CuT380A)']}], 'interventions': [{'name': 'Levonorgestrel-releasing intrauterine device (LNG-IUS)', 'type': 'DEVICE', 'otherNames': ['Mirena IUD'], 'description': 'Teens are randomly assigned to receive the LNG-IUS after completing a screening visit.', 'armGroupLabels': ['Mirena IUD [LNG-IUS]']}, {'name': 'Copper T380A intrauterine device (CuT380A)', 'type': 'DEVICE', 'otherNames': ['Paraguard IUD'], 'description': 'Teens are randomly assigned to Copper T380 after the screening visit', 'armGroupLabels': ['Paragard IUD [Copper T380A]']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Melissa Gilliam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Chicago Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Illinois at Chicago', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}