Trial · NCT00620464
A Bioequivalence Study of IMPLANON and Radiopaque IMPLANON (34528)(P05720)
NCT00620464, Phase 3, Completed, Organon and Co; results first posted 2010-05-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Bioequivalence Study of IMPLANON and Radiopaque IMPLANON (34528)(P05720). Trials, record NCT00620464. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00620464
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Bioequivalence Study of IMPLANON and Radiopaque IMPLANON (34528)(P05720)
- NCT number
- NCT00620464
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 108 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Contraception
- Interventions
- Radiopaque Implanon, Implanon (etonogestrel implant)
- First posted
- 2008-02-21
- Last updated
- 2022-02-04
- Results first posted
- 2010-05-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Bioequivalence of Implanon® and Radiopaque Implanon. | 3 years | Bioequivalence testing was performed based on serum etonogestrel AUC0-6months, AUC0-24months, and AUC0-36months. Bioequivalence was to be concluded when the 90% confidence limits of AUC0-6months, AUC0-24months, and AUC0-36months were fully contained within the acceptance range of 0.80-1.25. AUC0-6months (Area under the curve from zero to six months). AUC0-24months (Area under the curve from zero to 24 months). AUC0-36months (Area under the curve from zero to 36 months). |
| Primary | Bioequivalence of Implanon® and Radiopaque Implanon | 3 years | Bioequivalence testing was performed based on serum etonogestrel Cmax. Bioequivalence was to be concluded when the 90% confidence limits of Cmax were fully contained within the acceptance range of 0.80-1.25. Cmax (pg/mL): Peak concentration. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Bioequivalence of Implanon® and Radiopaque Implanon. | 3 years | 103 subjects were pharmacokinetically evaluable. Subjects were excluded from PK evaluation for use of protocol-prohibited steroidal medication during the trial or contraceptives within 1 week prior to Implanon insertion, or because their pre-insertion ENG concentration was not proven to be below the Lower Limit of Quantification (LLOQ) | pg•month/mL | MEAN |
| PRIMARY | Bioequivalence of Implanon® and Radiopaque Implanon | 3 years | All-Subjects-Pharmacokinetically-Evaluable consisted of 103 subjects.Subjects excluded from PK evaluation due to age, use of by protocol prohibited steroidal medication during trial and contraceptives within one week prior to Implanon insertion and their pre-insertion ENG concentration was not proven to be below Lower Limit Of Quantification (LLOQ) | pg/mL | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Bioequivalence of Implanon® and Radiopaque Implanon. | Radiopaque Implanon (ro Imp) | AUC (0-6 months) (n=46 ro imp; n=46 imp) | 2296 | Full Range 1320 to 4033 | pg•month/mL |
| Bioequivalence of Implanon® and Radiopaque Implanon. | Implanon (Imp) | AUC (0-6 months) (n=46 ro imp; n=46 imp) | 2290 | Full Range 1386 to 3773 | pg•month/mL |
| Bioequivalence of Implanon® and Radiopaque Implanon. | Radiopaque Implanon (ro Imp) | AUC (0-24 months) (n=37 ro imp; n=32 imp) | 5954 | Full Range 3687 to 10080 | pg•month/mL |
| Bioequivalence of Implanon® and Radiopaque Implanon. | Implanon (Imp) | AUC (0-24 months) (n=37 ro imp; n=32 imp) | 6131 | Full Range 3625 to 11500 | pg•month/mL |
| Bioequivalence of Implanon® and Radiopaque Implanon. | Radiopaque Implanon (ro Imp) | AUC (0-36 months) (n=32 ro imp; n=30 imp) | 7667 | Full Range 4702 to 12620 | pg•month/mL |
| Bioequivalence of Implanon® and Radiopaque Implanon. | Implanon (Imp) | AUC (0-36 months) (n=32 ro imp; n=30 imp) | 7819 | Full Range 4843 to 15114 | pg•month/mL |
| Bioequivalence of Implanon® and Radiopaque Implanon | Radiopaque Implanon (ro Imp) | 1200 | Full Range 509 to 3030 | pg/mL | |
| Bioequivalence of Implanon® and Radiopaque Implanon | Implanon (Imp) | 1145 | Full Range 317 to 3100 | pg/mL |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Radiopaque Implanon (ro Imp) | 52 | |
| Overall Study | STARTED | Implanon (Imp) | 56 | |
| Overall Study | COMPLETED | Radiopaque Implanon (ro Imp) | 32 | |
| Overall Study | COMPLETED | Implanon (Imp) | 32 | |
| Overall Study | NOT COMPLETED | Radiopaque Implanon (ro Imp) | 20 | |
| Overall Study | NOT COMPLETED | Implanon (Imp) | 24 |
Source ClinicalTrials.gov
Adverse events104
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 | Abdominal pain | Gastrointestinal disorders | Implanon | 2 | 56 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Radiopaque Implanon | 6 | 52 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | Implanon | 3 | 56 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Radiopaque Implanon | 5 | 52 | 7 |
| other | Nausea | Gastrointestinal disorders | Implanon | 8 | 56 | 9 |
| other | Nausea | Gastrointestinal disorders | Radiopaque Implanon | 6 | 52 | 8 |
| other | Toothache | Gastrointestinal disorders | Implanon | 3 | 56 | 3 |
| other | Toothache | Gastrointestinal disorders | Radiopaque Implanon | 1 | 52 | 1 |
| other | Fatigue | General disorders | Implanon | 3 | 56 | 5 |
| other | Fatigue | General disorders | Radiopaque Implanon | 2 | 52 | 2 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Implanon | ||
| Total, all-cause mortality | Radiopaque Implanon | ||
| Total, other adverse events | Implanon | 54 | 56 |
| Total, other adverse events | Radiopaque Implanon | 48 | 52 |
| Total, serious adverse events | Implanon | 6 | 56 |
| Total, serious adverse events | Radiopaque Implanon | 4 | 52 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22540269 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Implanon vs Radiopaque Implanon: serious adverse events |
Source Trial comparisons
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/NCT00620464
GET https://conductscience.org/api/trials/v1/NCT00620464/events?page=2