Trial · NCT00620035
A Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator (34530)(P05702)
NCT00620035, Phase 3, Completed, Organon and Co; results first posted 2011-10-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator (34530)(P05702). Trials, record NCT00620035. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00620035
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator (34530)(P05702)
- NCT number
- NCT00620035
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 301 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Contraception
- Interventions
- Radiopaque Etonogestrel Implant
- First posted
- 2008-02-21
- Last updated
- 2022-02-04
- Results first posted
- 2011-10-31
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Design & Technical Aspects | Day 1 | The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion. | Percentage of Applicator Users | NUMBER |
| PRIMARY | Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Functionality | Day 1 | The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion. | Percentage of Applicator Users | NUMBER |
| PRIMARY | Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire by Domain: Safety | Day 1 | The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion. | Percentage of Applicator Users | NUMBER |
| PRIMARY | Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Used Time | Day 1 | The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion. | Percentage of Applicator Users | NUMBER |
| PRIMARY | Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Applicator Satisfaction | Day 1 | The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion. | Percentage of Applicator Users | NUMBER |
| PRIMARY | Implant Insertion Time (Seconds) | Day 1 | All-Subjects-Treated (AST) group included all participants who had the Radiopaque implant inserted (N=301). Data was reported for 291 implant insertions. | Seconds | MEAN |
| PRIMARY | Implant Removal Time (Seconds) | Day 1 | All-Subjects-Treated (AST) group included all participants who had the Radiopaque implant inserted (N=301). Data was reported for 292 implant removals. | Seconds | MEAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Design & Technical Aspects | Radiopaque Etonogestrel Implant | 99.1 | Percentage of Applicator Users | ||
| Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Functionality | Radiopaque Etonogestrel Implant | 94.9 | Percentage of Applicator Users | ||
| Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire by Domain: Safety | Radiopaque Etonogestrel Implant | 98.6 | Percentage of Applicator Users | ||
| Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Used Time | Radiopaque Etonogestrel Implant | 100 | Percentage of Applicator Users | ||
| Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Applicator Satisfaction | Radiopaque Etonogestrel Implant | 100 | Percentage of Applicator Users | ||
| Implant Insertion Time (Seconds) | Radiopaque Etonogestrel Implant | 27.9 | Standard Deviation 29.3 | Seconds | |
| Implant Removal Time (Seconds) | Radiopaque Etonogestrel Implant | 119.3 | Standard Deviation 120.2 | Seconds |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Radiopaque Etonogestrel Implant | 301 | |
| Overall Study | COMPLETED | Radiopaque Etonogestrel Implant | 156 | |
| Overall Study | NOT COMPLETED | Radiopaque Etonogestrel Implant | 145 |
Source ClinicalTrials.gov
Adverse events33
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Implant Site Haematoma | General disorders | Radiopaque Etonogestrel Implant | 16 | 301 | 16 |
| other | Implant Site Pain | General disorders | Radiopaque Etonogestrel Implant | 18 | 301 | 20 |
| other | Influenza | Infections and infestations | Radiopaque Etonogestrel Implant | 19 | 301 | 22 |
| other | Nasopharyngitis | Infections and infestations | Radiopaque Etonogestrel Implant | 32 | 301 | 45 |
| other | Upper Respiratory Tract Infection | Infections and infestations | Radiopaque Etonogestrel Implant | 20 | 301 | 30 |
| other | Urinary Tract Infection | Infections and infestations | Radiopaque Etonogestrel Implant | 20 | 301 | 31 |
| other | Vulvovaginal Candidiasis | Infections and infestations | Radiopaque Etonogestrel Implant | 19 | 301 | 26 |
| other | Weight Increased | Investigations | Radiopaque Etonogestrel Implant | 35 | 301 | 38 |
| other | Headache | Nervous system disorders | Radiopaque Etonogestrel Implant | 56 | 301 | 103 |
| other | Amenorrhoea | Reproductive system and breast disorders | Radiopaque Etonogestrel Implant | 21 | 301 | 23 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Radiopaque Etonogestrel Implant | ||
| Total, other adverse events | Radiopaque Etonogestrel Implant | 233 | 301 |
| Total, serious adverse events | Radiopaque Etonogestrel Implant | 17 | 301 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22939402 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00620035
GET https://conductscience.org/api/trials/v1/NCT00620035/events?page=2