Clinical trial NCT00620035: A Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator (34530)(P05702)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 301
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Design & Technical Aspects
timeFrame: Day 1
measure: Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Functionality
timeFrame: Day 1
measure: Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire by Domain: Safety
timeFrame: Day 1
measure: Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Used Time
timeFrame: Day 1
measure: Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Applicator Satisfaction
timeFrame: Day 1
measure: Implant Insertion Time (Seconds)
timeFrame: Day 1
measure: Implant Removal Time (Seconds)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.