| February 11, 2008 |
| October 2, 2009 |
| May 2005 |
| February 2009 (final data collection date for primary outcome measure) |
| Bioequivalence as determined by AUC and Cmax for ENG. [ Time Frame: 6 months, 24 months and 36 months. ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00620464 on ClinicalTrials.gov Archive Site |
- Assessment of x-ray visibility by x-ray imaging. [ Time Frame: Just after rod insertion (<= 14 days), and just before rod removal (<= 14 days). ] [ Designated as safety issue: No ]
- Contraceptive efficacy as determined by urine pregnancy test. [ Time Frame: At screening, just before implant insertion, at all visits from month 2 onwards, and at 36 months (or at time of implant removal if discontinuing early). ] [ Designated as safety issue: No ]
- Drug safety as determined by [S]AE monitoring, physical and gynecological history/exams, vital signs, and inspection of implantation site. [ Time Frame: [S]AEs reported whenever they occur. Phys/gyn history/exams, and vital signs done at screening. Vital signs also done at each study visit (2 mos. onwards). Phys/gyn exams at 36 months. Inspection of implant site at 2 months and all subsequent visits. ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| A Bioequivalence Study of IMPLANON and Radiopaque IMPLANON (34528)(COMPLETED)(P05720) |
| A Randomized, Double-Blind, Parallel Group, Bioequivalence Study of IMPLANON and Radiopaque IMPLANON |
The primary purpose of this study is to demonstrate the bioequivalence of IMPLANON and Radiopaque IMPLANON. As a secondary objective, the x-ray visibility of Radiopaque IMPLANON will be assessed. |
| |
| Phase III |
| Interventional |
| Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Bio-equivalence Study |
| Contraception |
- Drug: Radiopaque Implanon
- Drug: Implanon (etonogestrel implant)
|
- Active Comparator: Radiopaque Implanon
- Active Comparator: Implanon (etonogestrel implant)
|
| |
| |
| Completed |
| 108 |
| February 2009 |
| February 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- At least 18 but not older than 40 years of age at the time of screening
- Good physical and mental health
- Regular cycles with a usual length between 24 and 35 days
- Body mass index = 18 and = 29
- Willing to give informed consent in writing
Exclusion Criteria:
Contraindications:
- known or suspected pregnancy
- active venous thromboembolic disorder (e.g. deep vein thrombosis,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 Implanon/Radiopaque Implanon
- 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
|
| Female |
| 18 Years to 40 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00620464 |
| Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| 34528, P05720 |
| Schering-Plough |
|
|
| Schering-Plough |
| October 2009 |