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

An Open-Label, Non-Controlled Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00620035

Enrollment

301

Registered

2008-02-21

Start date

2007-03-31

Completion date

2010-10-31

Last updated

2022-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

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.

Interventions

DRUGRadiopaque Etonogestrel Implant

One implant inserted for a 3-year treatment period

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Design & Technical Aspects	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.
Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Functionality	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.
Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire by Domain: Safety	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.
Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Used Time	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.
Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Applicator Satisfaction	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.
Implant Insertion Time (Seconds)	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.
Implant Removal Time (Seconds)	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.

Participant flow

Pre-assignment details

At screening, a participant number was allocated to 308 participants of which 7 participants did not receive treatment. A total of 301 participants had an implant inserted.

Participants by arm

Arm	Count
Radiopaque Etonogestrel Implant 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.	301
Total	301

Arm

Count

Radiopaque Etonogestrel Implant

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.

301

Total

301

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	106
Overall Study	Other Reason	38
Overall Study	Withdrawal of Informed Consent	1

Baseline characteristics

Characteristic	Radiopaque Etonogestrel Implant
Age, Customized 18-20 years	43 participants
Age, Customized 21-25 years	79 participants
Age, Customized 26-30 years	64 participants
Age, Customized 31-35 years	54 participants
Age, Customized 36-40 years	61 participants
Sex: Female, Male Female	301 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	233 / 301
serious Total, serious adverse events	17 / 301

Outcome results

Primary

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.

Time frame: Day 1

Population: All-Subjects-Treated (AST) group included all participants who had the Radiopaque implant inserted (N=301). Data was reported for 291 implant insertions.

Arm	Measure	Value (MEAN)	Dispersion
Radiopaque Etonogestrel Implant	Implant Insertion Time (Seconds)	27.9 Seconds	Standard Deviation 29.3

Primary

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.

Time frame: Day 1

Population: All-Subjects-Treated (AST) group included all participants who had the Radiopaque implant inserted (N=301). Data was reported for 292 implant removals.

Arm	Measure	Value (MEAN)	Dispersion
Radiopaque Etonogestrel Implant	Implant Removal Time (Seconds)	119.3 Seconds	Standard Deviation 120.2

Primary

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.

Time frame: Day 1