Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator (34530)(P05702)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00620035
Recruitment Status : Completed
First Posted : February 21, 2008
Results First Posted : October 31, 2011
Last Update Posted : February 4, 2022
Sponsor:
Information provided by (Responsible Party):
Organon and Co

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Contraception Drug: Radiopaque Etonogestrel Implant Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 301 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open-Label, Non-Controlled Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator
Study Start Date : March 2007
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Radiopaque Etonogestrel Implant

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.

 Drug: Radiopaque Etonogestrel Implant
One implant inserted for a 3-year treatment period
Other Name: SCH 900415


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Design & Technical Aspects [ Time Frame: Day 1 ]
    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.

  2. Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Functionality [ Time Frame: Day 1 ]
    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.

  3. Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire by Domain: Safety [ Time Frame: Day 1 ]
    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.

  4. Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Used Time [ Time Frame: Day 1 ]
    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.

  5. Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Applicator Satisfaction [ Time Frame: Day 1 ]
    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.

  6. Implant Insertion Time (Seconds) [ Time Frame: Day 1 ]
    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.

  7. Implant Removal Time (Seconds) [ Time Frame: Day 1 ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Organon and Co
ClinicalTrials.gov Identifier: NCT00620035    
Other Study ID Numbers: P05702
34530
First Posted: February 21, 2008    Key Record Dates
Results First Posted: October 31, 2011
Last Update Posted: February 4, 2022
Last Verified: February 2022
Additional relevant MeSH terms:
Layout table for MeSH terms
Etonogestrel
Contraceptive Agents, Hormonal
Contraceptive Agents
 Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female