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ContraceptionPhase 3NCT00620035

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

A Phase 3 study testing Radiopaque Etonogestrel Implant in people with Contraception, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception
What is being tested?
Radiopaque Etonogestrel Implant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
301 participants
Where
No sites listed yet
Study dates
Mar 2007to Oct 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 12Show fewer
  • 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

About this 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

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.

Conditions
Contraception
Being tested
Radiopaque Etonogestrel Implant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiopaque Etonogestrel ImplantDrug

    Also called SCH 900415

    One implant inserted for a 3-year treatment period

Study groups in NCT00620035
Study groupRoleWhat they receive
Radiopaque Etonogestrel ImplantExperimentalRadiopaque 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.
Receives: Drug: Radiopaque Etonogestrel Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Design & Technical Aspects

    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.

    Measured: Day 1

  2. Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Functionality

    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.

    Measured: Day 1

  3. Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire by Domain: Safety

    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.

    Measured: Day 1

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

    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.

    Measured: Day 1

  5. Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Applicator Satisfaction

    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.

    Measured: Day 1

  6. Implant Insertion Time (Seconds)

    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.

    Measured: Day 1

  7. Implant Removal Time (Seconds)

    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.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2008 (estimated)
  2. Study startMar 2007
  3. Primary completionOct 2010
  4. Study completionOct 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
301 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00620035
Sponsor's protocol ID
P05702
Other IDs
34530
Status last verified
Feb 2022
First submitted
11 Feb 2008
Last updated
4 Feb 2022
Data monitoring committee
No

Publications

  • Mommers E, Blum GF, Gent TG, Peters KP, Sordal TS, Marintcheva-Petrova M. Nexplanon, a radiopaque etonogestrel implant in combination with a next-generation applicator: 3-year results of a noncomparative multicenter trial. Am J Obstet Gynecol. 2012 Nov;207(5):388.e1-6. doi: 10.1016/j.ajog.2012.08.002. Epub 2012 Aug 10.

    PubMed 22939402

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Radiopaque Etonogestrel Implant in people with Contraception, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Design & Technical Aspects (time frame: Day 1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00620035, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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