Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-01-06 @ 12:20 PM
Study NCT ID:
NCT02070692
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2014-02-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tamoxifen for the Treatment of Unfavorable Bleeding in Contraceptive Implant Users
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013629', 'term': 'Tamoxifen'}], 'ancestors': [{'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'simmonka@ohsu.edu', 'phone': '404-718-6619', 'title': 'Dr. Katharine Simmons', 'organization': 'Oregon Health & Science University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Tamoxifen', 'description': 'Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.\n\nTamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding', 'otherNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.\n\nPlacebo: 7 day course of placebo during an episode of irregular vaginal bleeding', 'otherNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Bleeding Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tamoxifen', 'description': 'Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.\n\nTamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.\n\nPlacebo: 7 day course of placebo during an episode of irregular vaginal bleeding'}], 'classes': [{'categories': [{'measurements': [{'value': '65.6', 'spread': '37.5', 'groupId': 'OG000'}, {'value': '46.9', 'spread': '28.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180 days', 'description': 'The primary objective of this study is to determine whether tamoxifen taken by users of the ENG implant on an as-needed basis for frequent or prolonged bleeding can reduce the number of bleeding days by at least 40% over 180 days, when compared to placebo.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Bleeding/Spotting Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tamoxifen', 'description': 'Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.\n\nTamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.\n\nPlacebo: 7 day course of placebo during an episode of irregular vaginal bleeding'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '15.5', 'spread': '8.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Bleeding/spotting days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients analyzed is number of patients who completed 30 days of follow up. Two subjects in the tamoxifen arm and three in the placebo arm were lost to follow up prior to 30 days.'}, {'type': 'PRIMARY', 'title': 'Consecutive Bleeding-free Days After Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tamoxifen', 'description': 'Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.\n\nTamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.\n\nPlacebo: 7 day course of placebo during an episode of irregular vaginal bleeding'}], 'classes': [{'categories': [{'measurements': [{'value': '28.8', 'spread': '24.5', 'groupId': 'OG000'}, {'value': '13.6', 'spread': '19.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 180 days', 'description': 'Consecutive bleeding-free days after study drug', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects analyzed is the number of subjects who started taking the study drug. One subject in the tamoxifen arm and there in the placebo arm did not initiate study drug.'}, {'type': 'SECONDARY', 'title': 'Satisfaction (as Recorded on a 100mm Visual Analog Scale Where 0 is Not at All Satisfied and 100mm is Completely Satisfied)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tamoxifen', 'description': 'Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.\n\nTamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.\n\nPlacebo: 7 day course of placebo during an episode of irregular vaginal bleeding'}], 'classes': [{'categories': [{'measurements': [{'value': '61.4', 'spread': '24.7', 'groupId': 'OG000'}, {'value': '53.6', 'spread': '33.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180 days', 'description': 'Secondary objective is to determine whether tamoxifen can improve satisfaction with the implant and with bleeding patterns.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects analyzed is the number of subjects who completed a final study visit (either completion of full study or early termination visit) to provide a final estimation of satisfaction.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Ovulation After First Use of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tamoxifen', 'description': 'Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.\n\nTamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.\n\nPlacebo: 7 day course of placebo during an episode of irregular vaginal bleeding'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'A third secondary objective is to determine whether taking tamoxifen at this dose compromises ovulation suppression in ENG users. Tamoxifen is known to transiently raise serum estradiol levels, but does not affect gonadotropin release in premenopausal women. Therefore, it is unlikely to interact with the ovulation suppression provided by the implant. However, to further investigate any theoretical interaction between tamoxifen and etonogestrel, urine markers of ovulation will be collected to document ongoing ovulation suppression with intermittent tamoxifen use.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects analyzed are those that provided urine samples. No subject who provided urine samples was excluded from this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tamoxifen', 'description': 'Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.\n\nTamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.\n\nPlacebo: 7 day course of placebo during an episode of irregular vaginal bleeding'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tamoxifen', 'description': 'Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.\n\nTamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.\n\nPlacebo: 7 day course of placebo during an episode of irregular vaginal bleeding'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.4', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '36'}, {'value': '23.9', 'groupId': 'BG001', 'lowerLimit': '15', 'upperLimit': '38'}, {'value': '24.6', 'groupId': 'BG002', 'lowerLimit': '15', 'upperLimit': '38'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Male', '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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', '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': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Days of bleeding/spotting in 30 days prior to enrollment', 'classes': [{'categories': [{'measurements': [{'value': '17.3', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '22.2', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '19.75', 'spread': '7.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-13', 'studyFirstSubmitDate': '2014-02-21', 'resultsFirstSubmitDate': '2017-04-03', 'studyFirstSubmitQcDate': '2014-02-21', 'lastUpdatePostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-15', 'studyFirstPostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bleeding Days', 'timeFrame': '180 days', 'description': 'The primary objective of this study is to determine whether tamoxifen taken by users of the ENG implant on an as-needed basis for frequent or prolonged bleeding can reduce the number of bleeding days by at least 40% over 180 days, when compared to placebo.'}, {'measure': 'Bleeding/Spotting Days', 'timeFrame': '30 days', 'description': 'Bleeding/spotting days'}, {'measure': 'Consecutive Bleeding-free Days After Study Drug', 'timeFrame': 'up to 180 days', 'description': 'Consecutive bleeding-free days after study drug'}], 'secondaryOutcomes': [{'measure': 'Satisfaction (as Recorded on a 100mm Visual Analog Scale Where 0 is Not at All Satisfied and 100mm is Completely Satisfied)', 'timeFrame': '180 days', 'description': 'Secondary objective is to determine whether tamoxifen can improve satisfaction with the implant and with bleeding patterns.'}, {'measure': 'Number of Participants Experiencing Ovulation After First Use of Study Drug', 'timeFrame': '30 days', 'description': 'A third secondary objective is to determine whether taking tamoxifen at this dose compromises ovulation suppression in ENG users. Tamoxifen is known to transiently raise serum estradiol levels, but does not affect gonadotropin release in premenopausal women. Therefore, it is unlikely to interact with the ovulation suppression provided by the implant. However, to further investigate any theoretical interaction between tamoxifen and etonogestrel, urine markers of ovulation will be collected to document ongoing ovulation suppression with intermittent tamoxifen use.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contraceptive implant', 'Irregular vaginal bleeding', 'Etonogestrel implant'], 'conditions': ['Menstruation Disturbances']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to study whether a drug called tamoxifen can reduce vaginal bleeding in women who are using the Etonogestrel contraceptive implant.', 'detailedDescription': 'Nearly all of the 3 million unintended pregnancies in the United States each year result from inconsistent or non-use of contraception. Increasing use of the most effective methods of contraception will reduce unintended pregnancies and their social, medical and economic consequences. The contraceptive etonogestrel implant (ENG implant) is 20 times more effective at pregnancy prevention than oral contraceptive pills, but it has bleeding side effects that make it unappealing for many women. Tamoxifen, a selective estrogen receptor modulator (SERM) used most commonly for adjuvant treatment of breast cancer, has previously been shown to dramatically reduce bleeding in users of an older levonorgestrel-based contraceptive implant (Norplant tm). It has not been studied in newer progestin-based methods such as the ENG implant. If tamoxifen could stop bleeding in users of the ENG implant, it would give patients and physicians a valuable option for management of progestin-induced irregular bleeding. This research project will test the effectiveness of tamoxifen taken on an as-needed basis to treat abnormal bleeding in ENG implant users. If tamoxifen can be established as an effective treatment for frequent or prolonged bleeding, it will increase the acceptability of the ENG implant, increase its use and reduce unintended pregnancies. This is the first project to evaluate tamoxifen for treatment of unfavorable bleeding in users of the ENG contraceptive implant.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current user of the etonogestrel implant (Nexplanon, Implanon) for at least one month\n* Experiencing bleeding episodes more frequently than every 24 days, or a single episode of bleeding lasting longer than 14 days\n* English or Spanish speaking\n* Planning to continue implant use for six months\n* Access to a cell phone that can accept and send text messages\n\nExclusion Criteria:\n\n* Postpartum within six months\n* Post-abortion within six weeks\n* Pregnant\n* Breast-feeding\n* Undiagnosed abnormal uterine bleeding pre-dating placement of contraceptive implant\n* Bleeding dyscrasia\n* Anticoagulation use\n* Active cervicitis\n* Allergy to tamoxifen\n* History of venous thromboembolism\n* Current or past breast or uterine malignancy\n* Use of medication contraindicated with tamoxifen (coumadin, letrozole, bromocriptine, rifampicin, aminoglutethimide, phenobarbital)'}, 'identificationModule': {'nctId': 'NCT02070692', 'briefTitle': 'Tamoxifen for the Treatment of Unfavorable Bleeding in Contraceptive Implant Users', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Tamoxifen for the Treatment of Unfavorable Bleeding Patterns in Etonogestrel Contraceptive Implant Users', 'orgStudyIdInfo': {'id': 'SFPRF14-1'}, 'secondaryIdInfos': [{'id': 'SFPRF14-1', 'type': 'OTHER_GRANT', 'domain': 'Society of Family Planning'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tamoxifen', 'description': 'Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.', 'interventionNames': ['Drug: Tamoxifen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tamoxifen', 'type': 'DRUG', 'otherNames': ['Nolvadex'], 'description': '7 day course of tamoxifen during an episode of irregular vaginal bleeding', 'armGroupLabels': ['Tamoxifen']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '7 day course of placebo during an episode of irregular vaginal bleeding', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University (OHSU)', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Study under review for publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Society of Family Planning', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fellow in Family Planning', 'investigatorFullName': 'Katharine Simmons, MD', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}