Phase 3
Completed N=301
A Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator (34530)(P05702)
Source: ClinicalTrials.gov NCT00620035 ↗Enrolled (actual)
301
Serious AEs
5.7%
Results posted
Oct 2011
Primary outcomePrimary: Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Design & Technical Aspects — 99.1 Percentage of Applicator Users
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Design & Technical Aspects |
99.1 | — |
| PRIMARY Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Functionality |
94.9 | — |
| PRIMARY Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire by Domain: Safety |
98.6 | — |
| PRIMARY Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Used Time |
100 | — |
| PRIMARY Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Applicator Satisfaction |
100 | — |
| PRIMARY Implant Insertion Time (Seconds) |
27.9 | — |
| PRIMARY Implant Removal Time (Seconds) |
119.3 | — |
Eligibility Criteria
Inclusion Criteria
- Woman of at least (>=) 18 but not older than ( = 18 and 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
Data sourced from ClinicalTrials.gov (NCT00620035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.