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A Bioequivalence Study of IMPLANON and Radiopaque IMPLANON (34528)(COMPLETED)(P05720)
This study has been completed.
Study NCT00620464   Information provided by Schering-Plough
First Received: February 11, 2008   Last Updated: October 2, 2009   History of Changes

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)
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP