ContraceptionPhase 4NextOC2NCT04423055
Nexplanon Use in Women Primarily Choosing a Combined Oral Contraceptive
A Phase 4 study testing Etonogestrel contraceptive implant in people with Contraception, run by University of California, Davis at 3 sites in United States.
Trial summary
Women currently using or starting a combined oral contraceptive (COC) will be offered study enrollment. Study subjects will have a Nexplanon placed and followed for approximately 12 months to evaluate if they continue the implant, the COC, or both, and to assess bleeding patterns and adverse events. Read more about this study
- Who is it for?
- Ages 18 years and older, 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
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Aug 2020to 9 Apr 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women 18 years and older currently using COCs or who have a COC prescription and are intending to initiate COCs for contraception
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 [MEC])
- Because the CDC MEC are continuously revised, the most updated criteria will be used (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5904a3.htm)
- Women who are currently participating in a clinical trial or have participated within the past 30 days.
- Less than 2 weeks from the end of a pregnancy.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado
Denver, Colorado, 80045
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of California, Davis
Sacramento, California, 95817
About this study
Official title: Nexplanon Use in Women Primarily Choosing a Combined Oral Contraceptive: a Multicenter Trial
Women currently using or starting a combined oral contraceptive (COC) will be offered study enrollment. Study subjects will have a Nexplanon placed and followed for approximately 12 months to evaluate if they continue the implant, the COC, or both, and to assess bleeding patterns and adverse events.
Read the detailed description
This study will be conducted at three sites across the United States: University of California, Davis, University of Colorado and University of Pennsylvania. Investigators will recruit women currently using COCs or intending to initiate COCs for pregnancy prevention. Each site will recruit approximately 40 women for a total of 120 subjects.
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 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:
Follow up contact will be at approximately 4, 12, 26 and 39 weeks with the exit visit scheduled at 52 weeks.
At each follow up contact, the diary will be reviewed. 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. The ENG implant will be removed upon request at any time during the study.
Study participation will be complete after the 52 week (~ 12 month) exit visit.
No blood draws will occur during this study.
A diary will be used but no surveys will be used.
Data to be collected by study staff include demographics, past medical and gynecologic history, prior and current contraceptive use.
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. The investigators do 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
- Contraceptive implant, Nexplanon, Combined oral contraceptive
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 etonogestrel contraceptive implant.
| Study group | Role | What they receive |
|---|---|---|
| COC users or new starts | Experimental | Subjects will have an etonogestrel contraceptive implant placed at enrollment. Women using COC as method of contraception for at least 1 month will be considered COC users. Women using COC for less than 1 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 Implant as Acceptable
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: 52 weeks
Secondary outcomes (4)
Number of Participants Evaluating ENG as Tolerable: Tolerability
Evaluate the tolerability (side effects) of concomitant etonogestrel (ENG) implant use in women choosing a combined oral contraceptive (COC) for contraception
Measured: 52 weeks
Number of Participants Continuing COC
Continuation of COC over 52 weeks of evaluation regardless of whether or not the implant was still present at 52 weeks
Measured: 52 weeks
Bleeding Patterns
Bleeding patterns while using a COC concomitantly with ENG implant
Measured: 52 weeks
Post-study Method Plan
Plan to continue the COC and/or implant after the study based on interview at last visit
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start13 Aug 2020
- Primary completion9 Apr 2024
- Study completion9 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa C Matulich, MD MAS, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423055
- Sponsor's protocol ID
- 1571368
- Acronym
- NextOC2
- Status last verified
- Jun 2023
- First submitted
- 5 Jun 2020
- Last updated
- 22 May 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nexplanon Use in Women Primarily Choosing a Combined Oral Contraceptive: a Multicenter Trial
- ClinicalTrials.gov ID
- NCT04423055
- Acronym / sponsor ID
- NextOC2 / 1571368
- Conditions
- Contraception
- Keywords
- Contraceptive implant, Nexplanon, Combined oral contraceptive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, University of Colorado, Denver, University of Pennsylvania
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 9 Apr 2024 (actual)
- Study completion
- 9 Apr 2024 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
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 (COC) will be offered study enrollment. Study subjects will have a Nexplanon placed and followed for approximately 12 months to evaluate if they continue the implant, the COC, or both, and to assess bleeding patterns and adverse events.
Detailed description
This study will be conducted at three sites across the United States: University of California, Davis, University of Colorado and University of Pennsylvania. Investigators will recruit women currently using COCs or intending to initiate COCs for pregnancy prevention. Each site will recruit approximately 40 women for a total of 120 subjects.
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 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:
Follow up contact will be at approximately 4, 12, 26 and 39 weeks with the exit visit scheduled at 52 weeks.
At each follow up contact, the diary will be reviewed. 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. The ENG implant will be removed upon request at any time during the study.
Study participation will be complete after the 52 week (~ 12 month) exit visit.
No blood draws will occur during this study.
A diary will be used but no surveys will be used.
Data to be collected by study staff include demographics, past medical and gynecologic history, prior and current contraceptive use.
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. The investigators do 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 an etonogestrel contraceptive implant placed at enrollment. Women using COC as method of contraception for at least 1 month will be considered COC users. Women using COC for less than 1 month will be considered new starts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women 18 years and older currently using COCs or who have a COC prescription and are intending to initiate COCs for contraception
Key exclusion criteria (4 listed)
- Women who have contraindications to using a COC or a contraceptive implant (Category 3 or 4 in the CDC Medical Eligibility Criteria [MEC])
- Because the CDC MEC are continuously revised, the most updated criteria will be used (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5904a3.htm)
- Women who are currently participating in a clinical trial or have participated within the past 30 days.
- Less than 2 weeks from the end of a pregnancy.
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 etonogestrel contraceptive implant. | Drug | COC users or new starts |
Primary outcome
Number of Participants Evaluating ENG Implant as Acceptable
Time frame: 52 weeks
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
4 secondary outcomes
Number of Participants Evaluating ENG as Tolerable: Tolerability
Time frame: 52 weeks
Number of Participants Continuing COC
Time frame: 52 weeks
Bleeding Patterns
Time frame: 52 weeks
Post-study Method Plan
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- 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.
Melissa C Matulich, MD MAS principal investigator
University of California, Davis
3 sites 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 3 sites 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 1 inclusion and 4 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 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Implant as Acceptable (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2024.