ContraceptionPhase 3NCT00620464

A Bioequivalence Study of IMPLANON and Radiopaque IMPLANON (34528)(P05720)

A Phase 3 study testing Radiopaque Implanon and Implanon (etonogestrel implant) in people with Contraception, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary purpose of this study is to demonstrate the bioequivalence of IMPLANON and Radiopaque IMPLANON. Read more about this study

Who is it for?: Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Contraception
What is being tested?: Radiopaque Implanon and Implanon (etonogestrel implant)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 108 participants
Where: No sites listed yet
Study dates: May 2005to Feb 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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 ≤ 29
Willing to give informed consent in writing

Who cannot join

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

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hypersensitivity to any of the components of Implanon/Radiopaque Implanon
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 Implanon/Radiopaque Implanon 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 Implanon/Radiopaque Implanon

About this study

Official title: A Randomized, Double-Blind, Parallel Group, Bioequivalence Study of IMPLANON and Radiopaque IMPLANON

The primary purpose of this study is to demonstrate the bioequivalence of IMPLANON and Radiopaque IMPLANON.

Conditions: Contraception
Being tested: Radiopaque Implanon, Implanon (etonogestrel implant)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Radiopaque ImplanonDrug
Radiopaque rod for 3 years
Implanon (etonogestrel implant)Drug
Implanon (etonogestrel implant) for 3 years

Study groups in NCT00620464
Study group	Role	What they receive
Radiopaque Implanon (ro imp)	Active comparator	The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate. Receives: Drug: Radiopaque Implanon
Implanon (imp)	Active comparator	Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane. The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year. Receives: Drug: Implanon (etonogestrel implant)

What is being measured

The primary outcome is the main question the study is designed to answer.

Bioequivalence of Implanon® and Radiopaque Implanon.
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).
Measured: 3 years
Bioequivalence of Implanon® and Radiopaque Implanon
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.
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2005Feb 2009

First posted21 Feb 2008 (estimated)
Study startMay 2005
Primary completionFeb 2009
Study completionFeb 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ContraceptionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00620464
Sponsor's protocol ID: P05720
Other IDs: 34528
Status last verified: Feb 2022
First submitted: 11 Feb 2008
Last updated: 4 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Schnabel P, Merki-Feld GS, Malvy A, Duijkers I, Mommers E, van den Heuvel MW. Bioequivalence and x-ray visibility of a radiopaque etonogestrel implant versus a non-radiopaque implant: a 3-year, randomized, double-blind study. Clin Drug Investig. 2012 Jun 1;32(6):413-22. doi: 10.2165/11631930-000000000-00000.
PubMed 22540269

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Parallel Group, Bioequivalence Study of IMPLANON and Radiopaque IMPLANON
ClinicalTrials.gov ID: NCT00620464
Acronym / sponsor ID: P05720
Conditions: Contraception
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: May 2005
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 21 Feb 2008 (estimated)
Results: Posted 17 May 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary purpose of this study is to demonstrate the bioequivalence of IMPLANON and Radiopaque IMPLANON.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Radiopaque Implanon (ro imp)	Active comparator	Drug: Radiopaque ImplanonThe radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
Implanon (imp)	Active comparator	Drug: Implanon (etonogestrel implant)Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane. The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year.

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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 ≤ 29
Willing to give informed consent in writing

Key exclusion criteria (11 listed)

Contraindications:
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 Implanon/Radiopaque Implanon 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 Implanon/Radiopaque Implanon

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Radiopaque ImplanonRadiopaque rod for 3 years	Drug	Radiopaque Implanon (ro imp)
Implanon (etonogestrel implant)Implanon (etonogestrel implant) for 3 years	Drug	Implanon (imp)

Primary outcome

Bioequivalence of Implanon® and Radiopaque Implanon.
Time frame: 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).
Bioequivalence of Implanon® and Radiopaque Implanon
Time frame: 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.

Results and safety

Results posted to the registry on 17 May 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Radiopaque Implanon (ro Imp)	52	32
Implanon (Imp)	56	32

Primary outcome: Bioequivalence of Implanon® and Radiopaque Implanon.

Time frame: 3 years. Mean (Full Range). Unit: pg•month/mL

Measure	Radiopaque Implanon (ro Imp) n = 50	Implanon (Imp) n = 53
AUC (0-6 months) (n=46 ro imp; n=46 imp)	2296 (1320 to 4033)	2290 (1386 to 3773)
AUC (0-24 months) (n=37 ro imp; n=32 imp)	5954 (3687 to 10080)	6131 (3625 to 11500)
AUC (0-36 months) (n=32 ro imp; n=30 imp)	7667 (4702 to 12620)	7819 (4843 to 15114)

Radiopaque Implanon (ro Imp) vs Implanon (Imp): p = 0.05, Bioequivalence Testing

Population analysed: 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)

Primary outcome: Bioequivalence of Implanon® and Radiopaque Implanon

Time frame: 3 years. Mean (Full Range). Unit: pg/mL

Measure	Radiopaque Implanon (ro Imp) n = 50	Implanon (Imp) n = 53
Value	1200 (509 to 3030)	1145 (317 to 3100)

Radiopaque Implanon (ro Imp) vs Implanon (Imp): p <=0.05, Bioequivalence Testing

Population analysed: 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)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Implanon	6 of 56 (10.7%)	54 of 56 (96.4%)	Not reported
Radiopaque Implanon	4 of 52 (7.7%)	48 of 52 (92.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22540269Schnabel P, Merki-Feld GS, Malvy A, Duijkers I, Mommers E, van den Heuvel MW. Bioequivalence and x-ray visibility of a radiopaque etonogestrel implant versus a non-radiopaque implant: a 3-year, randomized, double-blind study. Clin Drug Investig. 2012 Jun 1;32(6):413-22. doi: 10.2165/11631930-000000000-00000.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Radiopaque Implanon and Implanon (etonogestrel implant) in people with Contraception, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bioequivalence of Implanon® and Radiopaque Implanon. (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00620464, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.