Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 34530 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiopaque Etonogestrel Implant | Experimental | Radiopaque Etonogestrel Implant (drug) inserted with the Next Generation Applicator (NGA) 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. The 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiopaque Etonogestrel Implant | Drug | One implant inserted for a 3-year treatment period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Design & Technical Aspects | 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. | Day 1 |
| Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Functionality | 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. | Day 1 |
| Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire by Domain: Safety | 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. | Day 1 |
| Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Used Time | 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Contraindications:
pulmonary embolism);
presence or history of severe hepatic disease as long as liver function values have not returned to normal;
malignancy or pre-malignancy, if sex-steroid-influenced;
undiagnosed vaginal bleeding;
hypersensitivity to any of the components of Radiopaque Implant.
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22939402 | Derived | 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. |
Not provided
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Radiopaque Etonogestrel Implant | 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. The 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Day 1 |
| Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Applicator Satisfaction | 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. | Day 1 |
| Implant Insertion Time (Seconds) | 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. | Day 1 |
| Implant Removal Time (Seconds) | 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. | Day 1 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Radiopaque Etonogestrel Implant | 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. The 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Design & Technical Aspects | 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. | The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion. | Posted | Number | Percentage of Applicator Users | Day 1 |
|
|
| ||||||||||||||||||||||||||
| Primary | Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Functionality | 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. | The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion. | Posted | Number | Percentage of Applicator Users | Day 1 |
|
| |||||||||||||||||||||||||||
| Primary | Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire by Domain: Safety | 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. | The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion. | Posted | Number | Percentage of Applicator Users | Day 1 |
| ||||||||||||||||||||||||||||
| Primary | Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Used Time | 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. | The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion. | Posted | Number | Percentage of Applicator Users | Day 1 |
|
| |||||||||||||||||||||||||||
| Primary | Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Applicator Satisfaction | 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. | The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion. | Posted | Number | Percentage of Applicator Users | Day 1 |
|
| |||||||||||||||||||||||||||
| Primary | Implant Insertion Time (Seconds) | 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. | All-Subjects-Treated (AST) group included all participants who had the Radiopaque implant inserted (N=301). Data was reported for 291 implant insertions. | Posted | Mean | Standard Deviation | Seconds | Day 1 |
|
| ||||||||||||||||||||||||||
| Primary | Implant Removal Time (Seconds) | 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. | All-Subjects-Treated (AST) group included all participants who had the Radiopaque implant inserted (N=301). Data was reported for 292 implant removals. | Posted | Mean | Standard Deviation | Seconds | Day 1 |
|
|
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).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Radiopaque Etonogestrel Implant | 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. The 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. | 17 | 301 | 233 | 301 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (13.1) |
| ||
| Jaundice | Hepatobiliary disorders | MedDRA (13.1) |
| ||
| Appendicitis | Infections and infestations | MedDRA (13.1) |
| ||
| Campylobacter gastroenteritis | Infections and infestations | MedDRA (13.1) |
| ||
| Salpingo-oophoritis | Infections and infestations | MedDRA (13.1) |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (13.1) |
| ||
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (13.1) |
| ||
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) |
| ||
| Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) |
| ||
| Thyroid Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) |
| ||
| Lethargy | Nervous system disorders | MedDRA (13.1) |
| ||
| Migraine | Nervous system disorders | MedDRA (13.1) |
| ||
| Sciatica | Nervous system disorders | MedDRA (13.1) |
| ||
| Bipolar Disorder | Psychiatric disorders | MedDRA (13.1) |
| ||
| Depression | Psychiatric disorders | MedDRA (13.1) |
| ||
| Suicide Attempt | Psychiatric disorders | MedDRA (13.1) |
| ||
| Calculus Urinary | Renal and urinary disorders | MedDRA (13.1) |
| ||
| Ovarian Cyst | Reproductive system and breast disorders | MedDRA (13.1) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant Site Haematoma | General disorders | MedDRA (13.1) |
| ||
| Implant Site Pain | General disorders | MedDRA (13.1) |
| ||
| Influenza | Infections and infestations | MedDRA (13.1) |
| ||
| Nasopharyngitis | Infections and infestations | MedDRA (13.1) |
| ||
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (13.1) |
| ||
| Urinary Tract Infection | Infections and infestations | MedDRA (13.1) |
| ||
| Vulvovaginal Candidiasis | Infections and infestations | MedDRA (13.1) |
| ||
| Weight Increased | Investigations | MedDRA (13.1) |
| ||
| Headache | Nervous system disorders | MedDRA (13.1) |
| ||
| Amenorrhoea | Reproductive system and breast disorders | MedDRA (13.1) |
| ||
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (13.1) |
| ||
| Menorrhagia | Reproductive system and breast disorders | MedDRA (13.1) |
| ||
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (13.1) |
| ||
| Vaginal Haemorrhage | Reproductive system and breast disorders | MedDRA (13.1) |
| ||
| Acne | Reproductive system and breast disorders | MedDRA (13.1) |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| Title | Measurements |
|---|---|
|
| 31-35 years |
|
| 36-40 years |
|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
|
|