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| ID | Type | Description | Link |
|---|---|---|---|
| 34528 |
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The primary purpose of this study is to demonstrate the bioequivalence of IMPLANON and Radiopaque IMPLANON.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiopaque Implanon (ro imp) | Active Comparator | The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate. |
|
| Implanon (imp) | Active Comparator | Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane. The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiopaque Implanon | Drug | Radiopaque rod for 3 years |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence of Implanon® and Radiopaque Implanon. | Bioequivalence testing was performed based on serum etonogestrel AUC0-6months, AUC0-24months, and AUC0-36months. Bioequivalence was to be concluded when the 90% confidence limits of AUC0-6months, AUC0-24months, and AUC0-36months were fully contained within the acceptance range of 0.80-1.25. AUC0-6months (Area under the curve from zero to six months). AUC0-24months (Area under the curve from zero to 24 months). AUC0-36months (Area under the curve from zero to 36 months). | 3 years |
| Bioequivalence of Implanon® and Radiopaque Implanon | Bioequivalence testing was performed based on serum etonogestrel Cmax. Bioequivalence was to be concluded when the 90% confidence limits of Cmax were fully contained within the acceptance range of 0.80-1.25. Cmax (pg/mL): Peak concentration. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications:
Hypertension, i.e. systolic blood pressure >140 mmHg and/or diastolic blood pressure > 90 mmHg.
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
Present use or use during 2 months prior to the start of Implanon/Radiopaque Implanon 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.
Administration of investigational drugs within 2 months prior to the start of Implanon/Radiopaque Implanon
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22540269 | Derived | Schnabel P, Merki-Feld GS, Malvy A, Duijkers I, Mommers E, van den Heuvel MW. Bioequivalence and x-ray visibility of a radiopaque etonogestrel implant versus a non-radiopaque implant: a 3-year, randomized, double-blind study. Clin Drug Investig. 2012 Jun 1;32(6):413-22. doi: 10.2165/11631930-000000000-00000. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiopaque Implanon (ro Imp) | The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate. |
| FG001 | Implanon (Imp) | Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane. The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiopaque Implanon (ro Imp) | The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate. |
| BG001 | Implanon (Imp) | Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane. The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/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 | Despite the protocol inclusion criteria, one patient was enrolled who was older than 40 years old. The subject was 43 years old. |
| 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 | Bioequivalence of Implanon® and Radiopaque Implanon. | Bioequivalence testing was performed based on serum etonogestrel AUC0-6months, AUC0-24months, and AUC0-36months. Bioequivalence was to be concluded when the 90% confidence limits of AUC0-6months, AUC0-24months, and AUC0-36months were fully contained within the acceptance range of 0.80-1.25. AUC0-6months (Area under the curve from zero to six months). AUC0-24months (Area under the curve from zero to 24 months). AUC0-36months (Area under the curve from zero to 36 months). | 103 subjects were pharmacokinetically evaluable. Subjects were excluded from PK evaluation for use of protocol-prohibited steroidal medication during the trial or contraceptives within 1 week prior to Implanon insertion, or because their pre-insertion ENG concentration was not proven to be below the Lower Limit of Quantification (LLOQ) | Posted | Mean | Full Range | pg•month/mL | 3 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Implanon | Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane. The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ligament rupture | Injury, poisoning and procedural complications | 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| C044815 | etonogestrel |
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| Implanon (etonogestrel implant) |
| Drug |
Implanon (etonogestrel implant) for 3 years |
|
| Planning Pregnancy |
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| Personal |
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| Used prohibited medication |
|
| BG002 | Total | Total of all reporting groups |
| Number |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate. |
| OG001 | Implanon (Imp) | Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane. The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year. |
|
|
|
| Primary | Bioequivalence of Implanon® and Radiopaque Implanon | Bioequivalence testing was performed based on serum etonogestrel Cmax. Bioequivalence was to be concluded when the 90% confidence limits of Cmax were fully contained within the acceptance range of 0.80-1.25. Cmax (pg/mL): Peak concentration. | All-Subjects-Pharmacokinetically-Evaluable consisted of 103 subjects.Subjects excluded from PK evaluation due to age, use of by protocol prohibited steroidal medication during trial and contraceptives within one week prior to Implanon insertion and their pre-insertion ENG concentration was not proven to be below Lower Limit Of Quantification (LLOQ) | Posted | Mean | Full Range | pg/mL | 3 years |
|
|
|
|
| 6 |
| 56 |
| 54 |
| 56 |
| EG001 | Radiopaque Implanon | The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate. | 4 | 52 | 48 | 52 |
| Peripheral nerve injury | Injury, poisoning and procedural complications | 11.1 | Systematic Assessment |
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| Tendon injury | Injury, poisoning and procedural complications | 11.1 | Systematic Assessment |
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| Tibia fracture | Injury, poisoning and procedural complications | 11.1 | Systematic Assessment |
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| Vertebral injury | Injury, poisoning and procedural complications | 11.1 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | 11.1 | Systematic Assessment |
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| Eating disorder | Psychiatric disorders | 11.1 | Systematic Assessment |
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| Mammoplasty | Surgical and medical procedures | 11.1 | Systematic Assessment |
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| Scar excision | Surgical and medical procedures | 11.1 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | 11.1 | Systematic Assessment |
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| Peripheral arterial occlusive disease | Vascular disorders | 11.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | 11.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | 11.1 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | 11.1 | Systematic Assessment |
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| Fatigue | General disorders | 11.1 | Systematic Assessment |
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| Hangover | General disorders | 11.1 | Systematic Assessment |
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| Implant site haematoma | General disorders | 11.1 | Systematic Assessment |
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| Implant site pain | General disorders | 11.1 | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | 11.1 | Systematic Assessment |
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| Cystitis | Infections and infestations | 11.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | 11.1 | Systematic Assessment |
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| Influenza | Infections and infestations | 11.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | 11.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | 11.1 | Systematic Assessment |
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| Vulvovaginal candidiasis | Infections and infestations | 11.1 | Systematic Assessment |
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| Vulvovaginal mycotic infection | Infections and infestations | 11.1 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | 11.1 | Systematic Assessment |
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| Weight decreased | Investigations | 11.1 | Systematic Assessment |
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| Weight increased | Investigations | 11.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | 11.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | 11.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | 11.1 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | 11.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | 11.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | 11.1 | Systematic Assessment |
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| Headache | Nervous system disorders | 11.1 | Systematic Assessment |
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| Amenorrhoea | Reproductive system and breast disorders | 11.1 | Systematic Assessment |
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| Breast pain | Reproductive system and breast disorders | 11.1 | Systematic Assessment |
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| Breast tenderness | Reproductive system and breast disorders | 11.1 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | 11.1 | Systematic Assessment |
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| Genital haemorrhage | Reproductive system and breast disorders | 11.1 | Systematic Assessment |
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| Metrorrhagia | Reproductive system and breast disorders | 11.1 | Systematic Assessment |
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| Oligomenorrhoea | Reproductive system and breast disorders | 11.1 | Systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | 11.1 | Systematic Assessment |
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| Polymenorrhoea | Reproductive system and breast disorders | 11.1 | Systematic Assessment |
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| Vaginal discharge | Reproductive system and breast disorders | 11.1 | Systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | 11.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | 11.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 11.1 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | 11.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | 11.1 | Systematic Assessment |
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All investigator publications must be based on data validated and released by sponsor. Any such scientific paper, presentation, or other communication concerning the clinical trial will first be submitted to sponsor, at least six weeks ahead of estimated publication or presentation, for consent. In the event that no response is received within six weeks after submission, the investigator may use the submitted data.