ContraceptionPhase 4NexTOCNCT02852265
Nexplanon and Combined Oral Contraceptive (COC) Combined Use Study
A Phase 4 study testing Etonogestrel contraceptive implant in people with Contraception, run by University of California, Davis at 1 site in United States.
Trial summary
Women currently using or starting a combined oral contraceptive will be offered study enrollment. Study subjects will have a Nexplanon placed and followed for 6 months to evaluate if they continue the COC, continue the implant, or both, and to assess adverse events and bleeding patterns. Read more about this study
- Who is it for?
- Ages 16 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Etonogestrel contraceptive implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2016to 26 Jul 2017
- Phase
- Phase 4
- 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 16 to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Women being seen in a UC Davis medical office or who contact our research office.
- Potential participants must be women currently COCs or intending to initiate COCs at the time of the office visit.
Who cannot join
- Women who have contraindications to using a COC or a contraceptive implant (Category 3 or 4 in the CDC Medical Eligibility Criteria) will be excluded.
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Sacramento, California, 95817
About this study
Official title: Nexplanon Use in Women Primarily Choosing a Combined Hormonal Contraceptive: a Proof of Concept Trial
Women currently using or starting a combined oral contraceptive will be offered study enrollment. Study subjects will have a Nexplanon placed and followed for 6 months to evaluate if they continue the COC, continue the implant, or both, and to assess adverse events and bleeding patterns.
Read the detailed description
The investigators will recruit women being seen in a UC Davis medical office or who contact our research office. Potential participants must be women currently COCs or intending to initiate COCs at the time of the office visit. The investigators expect that most women will be recruited while in the office who decide to initiate COCs or are continuing COC use-these women will be offered the ability to talk to research staff about the study.
Visit 1:
Informed consent will be obtained. As part of informed consent, subjects will be educated that there is little data available on the adverse effects of combined COC and ENG implant use. The consent form will include a standardized description of the side effects and bleeding profile of COCs and the implant. Subjects will also need to review the package label information for Nexplanon and sign the FDA-required Nexplanon consent. After obtaining informed consent, subjects will be screened for entry criteria. Medical history will be obtained. A urine pregnancy test will be performed. Eligible subjects will receive a prescription for the desired COC (if needed) and have a Nexplanon contraceptive implant placed. A diary will be dispensed for the subject to document daily bleeding, COC use and adverse events.
Follow-up A follow-up visit will occur at 1 month (+1 week) and 3 and 6 months (+2 weeks). The diary will be reviewed and a copy made to keep with the source documentation. Adverse events will be determined by inquiry and diary review. The subject will inform the study staff if she is using her COC and if she wants to continue use of her COC and ENG implant. At the 1 and 3 month visits, additional diaries will be dispensed as needed. The ENG implant will be removed upon request at any time during the study.
A phone call will occur approximately 1 week prior to the 3 and 6 month visits to check status and remind subject of the scheduled visit. Study participation will be complete after the 6 month follow-up visit.
No surveys will be used that the subject fills out herself. A daily diary will be used.
No blood draws will occur during this study.
Data to be collected by study staff include demographics, past medical and gynecologic history, prior and current contraceptive use, and reason for using COC (contraception, medical or both).
Because women are being enrolled who are already currently using COCs or who plan to start COCs, the COC is not a study drug. The study intervention (study drug) is the contraceptive implant. The systemic hormone exposure with a contraceptive implant is minimal relative to a COC. We would not expect any increase in side effects by adding a contraceptive implant to COC users. Of note, the primary risk with COC use is related to the estrogen which can increase the risk of venous thromboembolic disease. The implant has no estrogen. All products being used in the study are FDA-approved for contraception.
- Conditions
- Contraception
- Being tested
- Etonogestrel contraceptive implant
- Keywords
- oral contraceptive, contraceptive implant, contraception, adherence, adverse event
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etonogestrel contraceptive implantDrug
Also called Nexplanon
Place nexplanon
| Study group | Role | What they receive |
|---|---|---|
| COC users or new starts | Experimental | Subjects will have a etonogestrel contraceptive implant placed at enrollment. Women using COC as method of contraception for at least 1 month will be considered COC users. Women starting a COC or recently started a COC within the past month will be considered new starts. Receives: Drug: Etonogestrel contraceptive implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Evaluating ENG as Acceptable: Acceptability (Measurement: Questionnaire)
Evaluate the acceptability (continuation of the implant throughout the study) of concomitant etonogestrel (ENG) implant use in women choosing a combined oral contraceptive (COC) for contraception
Measured: 6 months
Number of Participants Evaluating ENG as Tolerable: Tolerability (Measurement: Diaries and Questionnaire)
Evaluate the tolerability (side effects) of concomitant etonogestrel (ENG) implant use in women choosing a combined oral contraceptive (COC) for contraception
Measured: 6 months
Secondary outcomes (4)
Patient Interest (Measurement: Ability to Enroll)
Demonstrate that women desiring a COC are willing to use ENG implant concomitantly as a continuous "back-up" contraceptive
Measured: 6 months
Bleeding Patterns (Measurement: Diaries)
Bleeding patterns while using a COC concomitantly with ENG implant
Measured: 6 months
COC Continuation Rate (Measurement: Participant Interview)
Continuation rate of COC over 6 months of evaluation regardless on whether or not the implant was still present at 6 months
Measured: 6 months
Post-study Method Plan (Measurement: Participant Interview)
Plan to continue the COC and/or implant after the study based on interview at last visit
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study start15 Sep 2016
- Primary completion26 Jul 2017
- Study completion26 Jul 2017
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.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Mitchell Creinin, MD, Principal investigator, Univeristy of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852265
- Sponsor's protocol ID
- 890433
- Acronym
- NexTOC
- Status last verified
- Dec 2018
- First submitted
- 13 Jul 2016
- Last updated
- 28 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chen MJ, Hsia JK, Creinin MD. Etonogestrel implant use in women primarily choosing a combined oral contraceptive pill: A proof-of-concept trial. Contraception. 2018 Jun;97(6):533-537. doi: 10.1016/j.contraception.2018.02.009. Epub 2018 Feb 26.
PubMed 29496473
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nexplanon Use in Women Primarily Choosing a Combined Hormonal Contraceptive: a Proof of Concept Trial
- ClinicalTrials.gov ID
- NCT02852265
- Acronym / sponsor ID
- NexTOC / 890433
- Conditions
- Contraception
- Keywords
- oral contraceptive, contraceptive implant, contraception, adherence, adverse event
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 15 Sep 2016 (actual)
- Primary completion
- 26 Jul 2017 (actual)
- Study completion
- 26 Jul 2017 (actual)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Posted 12 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women currently using or starting a combined oral contraceptive will be offered study enrollment. Study subjects will have a Nexplanon placed and followed for 6 months to evaluate if they continue the COC, continue the implant, or both, and to assess adverse events and bleeding patterns.
Detailed description
The investigators will recruit women being seen in a UC Davis medical office or who contact our research office. Potential participants must be women currently COCs or intending to initiate COCs at the time of the office visit. The investigators expect that most women will be recruited while in the office who decide to initiate COCs or are continuing COC use-these women will be offered the ability to talk to research staff about the study.
Visit 1:
Informed consent will be obtained. As part of informed consent, subjects will be educated that there is little data available on the adverse effects of combined COC and ENG implant use. The consent form will include a standardized description of the side effects and bleeding profile of COCs and the implant. Subjects will also need to review the package label information for Nexplanon and sign the FDA-required Nexplanon consent. After obtaining informed consent, subjects will be screened for entry criteria. Medical history will be obtained. A urine pregnancy test will be performed. Eligible subjects will receive a prescription for the desired COC (if needed) and have a Nexplanon contraceptive implant placed. A diary will be dispensed for the subject to document daily bleeding, COC use and adverse events.
Follow-up A follow-up visit will occur at 1 month (+1 week) and 3 and 6 months (+2 weeks). The diary will be reviewed and a copy made to keep with the source documentation. Adverse events will be determined by inquiry and diary review. The subject will inform the study staff if she is using her COC and if she wants to continue use of her COC and ENG implant. At the 1 and 3 month visits, additional diaries will be dispensed as needed. The ENG implant will be removed upon request at any time during the study.
A phone call will occur approximately 1 week prior to the 3 and 6 month visits to check status and remind subject of the scheduled visit. Study participation will be complete after the 6 month follow-up visit.
No surveys will be used that the subject fills out herself. A daily diary will be used.
No blood draws will occur during this study.
Data to be collected by study staff include demographics, past medical and gynecologic history, prior and current contraceptive use, and reason for using COC (contraception, medical or both).
Because women are being enrolled who are already currently using COCs or who plan to start COCs, the COC is not a study drug. The study intervention (study drug) is the contraceptive implant. The systemic hormone exposure with a contraceptive implant is minimal relative to a COC. We would not expect any increase in side effects by adding a contraceptive implant to COC users. Of note, the primary risk with COC use is related to the estrogen which can increase the risk of venous thromboembolic disease. The implant has no estrogen. All products being used in the study are FDA-approved for contraception.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COC users or new starts | Experimental | Drug: Etonogestrel contraceptive implantSubjects will have a etonogestrel contraceptive implant placed at enrollment. Women using COC as method of contraception for at least 1 month will be considered COC users. Women starting a COC or recently started a COC within the past month will be considered new starts. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Women being seen in a UC Davis medical office or who contact our research office.
- Potential participants must be women currently COCs or intending to initiate COCs at the time of the office visit.
Key exclusion criteria (5 listed)
- Women who have contraindications to using a COC or a contraceptive implant (Category 3 or 4 in the CDC Medical Eligibility Criteria) will be excluded.
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
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 |
|---|---|---|
| Etonogestrel contraceptive implantAlso: NexplanonPlace nexplanon | Drug | COC users or new starts |
Primary outcome
Number of Participants Evaluating ENG as Acceptable: Acceptability (Measurement: Questionnaire)
Time frame: 6 months
Evaluate the acceptability (continuation of the implant throughout the study) of concomitant etonogestrel (ENG) implant use in women choosing a combined oral contraceptive (COC) for contraception
Number of Participants Evaluating ENG as Tolerable: Tolerability (Measurement: Diaries and Questionnaire)
Time frame: 6 months
Evaluate the tolerability (side effects) of concomitant etonogestrel (ENG) implant use in women choosing a combined oral contraceptive (COC) for contraception
4 secondary outcomes
Patient Interest (Measurement: Ability to Enroll)
Time frame: 6 months
Bleeding Patterns (Measurement: Diaries)
Time frame: 6 months
COC Continuation Rate (Measurement: Participant Interview)
Time frame: 6 months
Post-study Method Plan (Measurement: Participant Interview)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29496473Chen MJ, Hsia JK, Creinin MD. Etonogestrel implant use in women primarily choosing a combined oral contraceptive pill: A proof-of-concept trial. Contraception. 2018 Jun;97(6):533-537. doi: 10.1016/j.contraception.2018.02.009. Epub 2018 Feb 26.
- Individual participant dataSharing planned: No
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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.
Mitchell Creinin, MD principal investigator
Univeristy of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etonogestrel contraceptive implant in people with Contraception, run by University of California, Davis at 1 site in United States.
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 2 inclusion and 5 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 28 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 12 Jul 2018). 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?
Number of Participants Evaluating ENG as Acceptable: Acceptability (Measurement: Questionnaire) (time frame: 6 months). 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 NCT02852265, 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 28 Dec 2018.