Full Text View
Tabular View
No Study Results Posted
Related Studies
A Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator (34530)
This study is ongoing, but not recruiting participants.
First Received: February 11, 2008   Last Updated: April 29, 2009   History of Changes
Sponsored by: Organon
Information provided by: Organon
ClinicalTrials.gov Identifier: NCT00620035
  Purpose

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 subject expectations and satisfaction with the Radiopaque Implant.


Condition Intervention Phase
Contraception
Drug: Radiopaque Etonogestrel Implant
Phase III

MedlinePlus related topics: X-Rays
Drug Information available for: Etonogestrel
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: An Open-Label, Non-Controlled Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator

Further study details as provided by Organon:

Primary Outcome Measures:
  • Functionality/Safety of NGIA as determined by evaluation of "User [HCP] Satisfaction Questionaires", insertion characteristics [e.g. insertion times], insertion site complications, and evaluation of non -medical technical complaints involving the NGIA [ Time Frame: Evaluations done at time of implant insertion. Follow-up implant site inspections for possible complications to be done at all study visits ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall ease and safety of implant removal as determined by removal characteristics, and evaluation of any implant site complications. [ Time Frame: At time of implant removal. ] [ Designated as safety issue: Yes ]
  • Contraceptive efficacy as determined by urine pregnancy test. [ Time Frame: At screening, just before implant insertion, at all visits from month 3 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 implant site for any complications. [ 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. Phys/gyn exams at 36 months. Inspection of implant site done at implantation and all subsequent visits. ] [ Designated as safety issue: Yes ]
  • X-ray visibility of the Radiopaque Implant as determined by 2-dimensional x-ray imaging. [ Time Frame: X-ray imaging performed just after implant insertion, and just before implant removal (study subset: 1st 50 subjects only). ] [ Designated as safety issue: No ]
  • Subject expectations and satisfaction with Radiopaque IMPLANON evaluated using "Patient Reported Outcome" (PRO) instruments. [ Time Frame: Questionaire to be completed at screening, and at month 3, 6, 12, 24 and 36 visits. ] [ Designated as safety issue: No ]

Enrollment: 301
Study Start Date: April 2007
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1: Active Comparator
Radiopaque Etonogestrel Implant (drug) inserted with the Next Generation Implanon Applicator
Drug: Radiopaque Etonogestrel Implant
One implant for 3 years

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Woman of 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 = 35 kg/m^2;
  • 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 Radiopaque Implant.
  • 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 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;
  • Administration of investigational drugs within 2 months prior to the start of Radiopaque Implant
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers: 34530, P05702
Study First Received: February 11, 2008
Last Updated: April 29, 2009
ClinicalTrials.gov Identifier: NCT00620035     History of Changes
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration;   France: Afssaps - French Health Products Safety Agency;   Germany: Federal Institute for Drugs and Medical Devices;   Norway: Norwegian Medicines Agency;   Sweden: Medical Products Agency;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:
Desogestrel
Contraceptive Agents
Contraceptive Agents, Female
3-keto-desogestrel

Additional relevant MeSH terms:
Contraceptive Agents
Therapeutic Uses
Physiological Effects of Drugs
Contraceptive Agents, Female
Reproductive Control Agents
3-keto-desogestrel
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009