Phase 3 N=301 Prevention

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

Contraception

Bottom Line

View on ClinicalTrials.gov: NCT00620035 ↗

Enrolled (actual)

301

Serious AEs

5.7%

Results posted

Oct 2011

Primary outcome: Primary: Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Design & Technical Aspects — 99.1 Percentage of Applicator Users

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Radiopaque Etonogestrel Implant (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Organon and Co
Primary completion: Oct 2010

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	—

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 ( = 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

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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.