Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-01-04 @ 4:06 AM
Study NCT ID:
NCT00620035
Status:
COMPLETED
Last Update Posted:
2022-02-04
First Post:
2008-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator (34530)(P05702)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'France', 'Germany', 'Norway', 'Sweden', 'United Kingdom']}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'SPONSOR recognizes the right of the investigator(s) to publish, but all publications must be based on data validated and released by SPONSOR. Any such scientific paper, presentation, or other communication concerning the clinical trial described in protocol will first be submitted to SPONSOR, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).', 'description': 'The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.', 'eventGroups': [{'id': 'EG000', 'title': 'Radiopaque Etonogestrel Implant', 'description': 'The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.\n\nThe ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year.', 'otherNumAtRisk': 301, 'otherNumAffected': 233, 'seriousNumAtRisk': 301, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Implant Site Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Implant Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 22, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 45, 'numAffected': 32}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 30, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 31, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Vulvovaginal Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 26, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Weight Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 38, 'numAffected': 35}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 103, 'numAffected': 56}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Amenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 23, 'numAffected': 21}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 35, 'numAffected': 31}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 60, 'numAffected': 53}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Vaginal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 126, 'numAffected': 85}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 48, 'numAffected': 39}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA (13.1)'}], 'seriousEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Campylobacter gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Salpingo-oophoritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Thyroid Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Bipolar Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Suicide Attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Calculus Urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Ovarian Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA (13.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Design & Technical Aspects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiopaque Etonogestrel Implant', 'description': 'The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.\n\nThe ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': "In order to evaluate efficacy and ease of use of the Next Generation Applicator (NGA), the investigator/applicator user (AU) completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Design/technical aspects' consisted of five questions: fit of the applicator in the hand, size, weight, handling, and color of the applicator were assessed. The percentage of AUs who were very satisfied and satisfied was presented.", 'unitOfMeasure': 'Percentage of Applicator Users', 'reportingStatus': 'POSTED', 'populationDescription': 'The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.'}, {'type': 'PRIMARY', 'title': 'Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Functionality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiopaque Etonogestrel Implant', 'description': 'The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.\n\nThe ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': "In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Functionality' consisted of six questions assessing functionality of the needle. The percentage of AUs who were very satisfied and satisfied was presented.", 'unitOfMeasure': 'Percentage of Applicator Users', 'reportingStatus': 'POSTED', 'populationDescription': 'The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.'}, {'type': 'PRIMARY', 'title': 'Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire by Domain: Safety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiopaque Etonogestrel Implant', 'description': 'The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.\n\nThe ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': "In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Safety' consisted of three questions: removal of the protection cap from applicator, full retraction of the needle into the applicator after insertion, difference in colors of the obturator \\& the implant. The percentage of AUs who were very satisfied and satisfied was presented.", 'unitOfMeasure': 'Percentage of Applicator Users', 'reportingStatus': 'POSTED', 'populationDescription': 'The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.'}, {'type': 'PRIMARY', 'title': 'Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Used Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiopaque Etonogestrel Implant', 'description': 'The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.\n\nThe ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': "In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Used Time' consisted of one question: insertion time was assessed. The percentage of AUs who were very satisfied and satisfied was presented.", 'unitOfMeasure': 'Percentage of Applicator Users', 'reportingStatus': 'POSTED', 'populationDescription': 'The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.'}, {'type': 'PRIMARY', 'title': 'Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Applicator Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiopaque Etonogestrel Implant', 'description': 'The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.\n\nThe ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': "In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Applicator Satisfaction' consisted of one question in order to assess the applicator. The percentage of AUs who were very satisfied and satisfied was presented.", 'unitOfMeasure': 'Percentage of Applicator Users', 'reportingStatus': 'POSTED', 'populationDescription': 'The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.'}, {'type': 'PRIMARY', 'title': 'Implant Insertion Time (Seconds)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiopaque Etonogestrel Implant', 'description': 'The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.\n\nThe ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.9', 'spread': '29.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'The implant insertion time was the time expressed in seconds, from removal of the protection cap from the applicator until retraction of the needle from the arm after insertion. Data was presented for overall investigators including experienced and non-experienced.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All-Subjects-Treated (AST) group included all participants who had the Radiopaque implant inserted (N=301). Data was reported for 291 implant insertions.'}, {'type': 'PRIMARY', 'title': 'Implant Removal Time (Seconds)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiopaque Etonogestrel Implant', 'description': 'The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.\n\nThe ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year.'}], 'classes': [{'categories': [{'measurements': [{'value': '119.3', 'spread': '120.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'The implant removal time was the time expressed in seconds, from making the removal incision until placing the butterfly closure. Data was presented for overall investigators including experienced and non-experienced.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All-Subjects-Treated (AST) group included all participants who had the Radiopaque implant inserted (N=301). Data was reported for 292 implant removals.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Radiopaque Etonogestrel Implant', 'description': 'The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.\n\nThe ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '301'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '156'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '145'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '106'}]}, {'type': 'Withdrawal of Informed Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '38'}]}]}], 'preAssignmentDetails': 'At screening, a participant number was allocated to 308 participants of which 7 participants did not receive treatment. A total of 301 participants had an implant inserted.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Radiopaque Etonogestrel Implant', 'description': 'The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.\n\nThe ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18-20 years', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}, {'title': '21-25 years', 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}]}]}, {'title': '26-30 years', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}]}]}, {'title': '31-35 years', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}, {'title': '36-40 years', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '301', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 301}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-02', 'studyFirstSubmitDate': '2008-02-11', 'resultsFirstSubmitDate': '2011-09-22', 'studyFirstSubmitQcDate': '2008-02-11', 'lastUpdatePostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-09-22', 'studyFirstPostDateStruct': {'date': '2008-02-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Design & Technical Aspects', 'timeFrame': 'Day 1', 'description': "In order to evaluate efficacy and ease of use of the Next Generation Applicator (NGA), the investigator/applicator user (AU) completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Design/technical aspects' consisted of five questions: fit of the applicator in the hand, size, weight, handling, and color of the applicator were assessed. The percentage of AUs who were very satisfied and satisfied was presented."}, {'measure': 'Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Functionality', 'timeFrame': 'Day 1', 'description': "In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Functionality' consisted of six questions assessing functionality of the needle. The percentage of AUs who were very satisfied and satisfied was presented."}, {'measure': 'Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire by Domain: Safety', 'timeFrame': 'Day 1', 'description': "In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Safety' consisted of three questions: removal of the protection cap from applicator, full retraction of the needle into the applicator after insertion, difference in colors of the obturator \\& the implant. The percentage of AUs who were very satisfied and satisfied was presented."}, {'measure': 'Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Used Time', 'timeFrame': 'Day 1', 'description': "In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Used Time' consisted of one question: insertion time was assessed. The percentage of AUs who were very satisfied and satisfied was presented."}, {'measure': 'Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Applicator Satisfaction', 'timeFrame': 'Day 1', 'description': "In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Applicator Satisfaction' consisted of one question in order to assess the applicator. The percentage of AUs who were very satisfied and satisfied was presented."}, {'measure': 'Implant Insertion Time (Seconds)', 'timeFrame': 'Day 1', 'description': 'The implant insertion time was the time expressed in seconds, from removal of the protection cap from the applicator until retraction of the needle from the arm after insertion. Data was presented for overall investigators including experienced and non-experienced.'}, {'measure': 'Implant Removal Time (Seconds)', 'timeFrame': 'Day 1', 'description': 'The implant removal time was the time expressed in seconds, from making the removal incision until placing the butterfly closure. Data was presented for overall investigators including experienced and non-experienced.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Contraception']}, 'referencesModule': {'references': [{'pmid': '22939402', 'type': 'DERIVED', 'citation': 'Mommers E, Blum GF, Gent TG, Peters KP, Sordal TS, Marintcheva-Petrova M. Nexplanon, a radiopaque etonogestrel implant in combination with a next-generation applicator: 3-year results of a noncomparative multicenter trial. Am J Obstet Gynecol. 2012 Nov;207(5):388.e1-6. doi: 10.1016/j.ajog.2012.08.002. Epub 2012 Aug 10.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the use of the next generation applicator and its instructions for proper insertion of the Radiopaque Implant. Secondary objectives include: evaluation of implant removal, evaluation of the overall contraceptive efficacy and safety of the Radiopaque Implant, assessment of x -ray visibility of the Radiopaque Implant, and to assess participant expectations and satisfaction with the Radiopaque Implant.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Woman of at least (\\>=) 18 but not older than (\\<= )40 years of age at the time of screening;\n* Good physical and mental health;\n* Regular cycles with a usual length between 24 and 35 days;\n* Body mass index \\>= 18 and \\<= 35 kg/m\\^2;\n* Willing to give informed consent in writing.\n\nExclusion Criteria:\n\n* Contraindications:\n\n * known or suspected pregnancy;\n * active venous thromboembolic disorder (e.g. deep vein thrombosis,\n\npulmonary embolism);\n\n* presence or history of severe hepatic disease as long as liver function values have not returned to normal;\n* malignancy or pre-malignancy, if sex-steroid-influenced;\n* undiagnosed vaginal bleeding;\n* hypersensitivity to any of the components of Radiopaque Implant.\n\n * Hypertension, i.e. systolic blood pressure \\>140 mmHg and/or diastolic blood pressure \\> 90 mmHg;\n * A history during pregnancy or during previous use of sex steroids of: jaundice and/or severe pruritus related to cholestasis, gallstone formation, porphyria, systemic lupus erythematosus, haemolytic uraemic syndrome, Sydenham's chorea, herpes gestationis, otosclerosis-related hearing loss;\n * Present use or use during 2 months prior to the start of Radiopaque Implant of one of the following drugs: phenytoin, phenobarbital, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, ritonavir, nelfinavir, griseofulvin or the herbal remedy St John's wort;\n * Administration of investigational drugs within 2 months prior to the start of Radiopaque Implant"}, 'identificationModule': {'nctId': 'NCT00620035', 'briefTitle': 'A Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator (34530)(P05702)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'An Open-Label, Non-Controlled Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator', 'orgStudyIdInfo': {'id': 'P05702'}, 'secondaryIdInfos': [{'id': '34530'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiopaque Etonogestrel Implant', 'description': 'Radiopaque Etonogestrel Implant (drug) inserted with the Next Generation Applicator (NGA)\n\nThe Radiopaque Implant is a single rod contraceptive implant of 4 cm length and\n\n2 mm in diameter which is placed at the inner side of the non-dominant upper-arm\n\nabout 8-10 cm above the medial epicondyle. The Radiopaque Implant contains\n\napproximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.\n\nThe ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year.', 'interventionNames': ['Drug: Radiopaque Etonogestrel Implant']}], 'interventions': [{'name': 'Radiopaque Etonogestrel Implant', 'type': 'DRUG', 'otherNames': ['SCH 900415'], 'description': 'One implant inserted for a 3-year treatment period', 'armGroupLabels': ['Radiopaque Etonogestrel Implant']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}