Contraception BehaviorPhase 4NCT04828824
Premature Discontinuation of Contraceptive Implants
A Phase 4 study testing Ethinyl Estradiol / Norgestimate Oral Tablet in people with Contraception Behavior, run by University of Colorado, Denver at 1 site in United States.
Trial summary
To compare rates of etonogestrel implant discontinuation in implant initiators who are given advance provision of combined oral contraceptive pills (COCs) and a bleeding rescue regimen (COCR intervention) to participants given standard counseling (comparator). Read more about this study
- Who is it for?
- Ages 14 to 23 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception Behavior
- What is being tested?
- Ethinyl Estradiol / Norgestimate Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2021to 12 Nov 2025
- 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 14 to 23 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- You are between ages of 14 to 22.9 years.
- Started etonogestrel implant for the first time and have never used the implant before.
Who cannot join
- There is any contraindication to estrogen containing birth control.
- Desire of pregnancy in next 12 months.
- Plans to move from the area in next 12 months and is not able to come to the clinic.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Reduction of Premature Discontinuation of Contraceptive Implants by Advance Provision of an OCP-based Participant Intervention: Randomized Clinical Trial
To compare rates of etonogestrel implant discontinuation in implant initiators who are given advance provision of combined oral contraceptive pills (COCs) and a bleeding rescue regimen (COCR intervention) to participants given standard counseling (comparator).
Read the detailed description
Objective:
To compare rates of etonogestrel implant discontinuation in implant initiators who are given advance provision of combined oral contraceptive pills (COCs) and a bleeding rescue regimen (COCR intervention) to participants given standard counseling (comparator).
Secondary Objectives:
To determine if participants initiating the contraceptive implant who are also provided COCR are more likely than participants receiving standard counseling to:
- report higher levels of satisfaction with their contraceptive implant at one year following initiation
- require less clinical follow-up and clinical resources in the year following initiation.
- Conditions
- Contraception Behavior
- Being tested
- Ethinyl Estradiol / Norgestimate Oral Tablet
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethinyl Estradiol / Norgestimate Oral TabletDrug
Those who desire COCs as an intervention are prescribed (over the phone) or given (in person) 3 packs of COCs. They are told to take one pill per day until the first pack is complete and save the remaining 2 packs for possible future use.
| Study group | Role | What they receive |
|---|---|---|
| COCR Arm | Experimental | Participants in the COCR arm will receive three packs of combined oral contraceptive pills (35mcg ethinyl estradiol/norgestimate) and a specific protocol for their use for bothersome bleeding. Receives: Drug: Ethinyl Estradiol / Norgestimate Oral Tablet |
| SOC Arm | No intervention | Participants in the SC arm will be offered care according to our standardized protocol, which may include STI testing, reassurance and monitoring, prescription of COCs if desired, or removal. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Implant Continuation
We will assess continuation of use of the contraceptive implant.
Measured: 12 months post-insertion
Secondary outcomes (1)
Overall Satisfaction With Contraceptive Implant
We will assess satisfaction with the bleeding profile and overall satisfaction using a Likert scale ("very satisfied", "somewhat satisfied" and "not satisfied"). Overall satisfaction at 12 months will be used as a measure for data analysis.
Measured: Assessed at 3, 6, and 12 months post-insertion, 12 months reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start18 Jun 2021
- Primary completion12 Nov 2025
- Study completion12 Nov 2025
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.
- Other trials for Contraception BehaviorStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828824
- Sponsor's protocol ID
- 19-2750
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2021
- Last updated
- 23 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Premature Discontinuation of Contraceptive Implants by Advance Provision of an OCP-based Participant Intervention: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04828824
- Acronym / sponsor ID
- 19-2750
- Conditions
- Contraception Behavior
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Posted 23 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare rates of etonogestrel implant discontinuation in implant initiators who are given advance provision of combined oral contraceptive pills (COCs) and a bleeding rescue regimen (COCR intervention) to participants given standard counseling (comparator).
Detailed description
Objective:
To compare rates of etonogestrel implant discontinuation in implant initiators who are given advance provision of combined oral contraceptive pills (COCs) and a bleeding rescue regimen (COCR intervention) to participants given standard counseling (comparator).
Secondary Objectives:
To determine if participants initiating the contraceptive implant who are also provided COCR are more likely than participants receiving standard counseling to:
- report higher levels of satisfaction with their contraceptive implant at one year following initiation
- require less clinical follow-up and clinical resources in the year following initiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COCR Arm | Experimental | Drug: Ethinyl Estradiol / Norgestimate Oral TabletParticipants in the COCR arm will receive three packs of combined oral contraceptive pills (35mcg ethinyl estradiol/norgestimate) and a specific protocol for their use for bothersome bleeding. |
| SOC Arm | No intervention | –Participants in the SC arm will be offered care according to our standardized protocol, which may include STI testing, reassurance and monitoring, prescription of COCs if desired, or removal. |
Who may qualify
- Ages
- 14 to 23 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- You are between ages of 14 to 22.9 years.
- Started etonogestrel implant for the first time and have never used the implant before.
Key exclusion criteria (3 listed)
- There is any contraindication to estrogen containing birth control.
- Desire of pregnancy in next 12 months.
- Plans to move from the area in next 12 months and is not able to come to the clinic.
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 |
|---|---|---|
| Ethinyl Estradiol / Norgestimate Oral TabletThose who desire COCs as an intervention are prescribed (over the phone) or given (in person) 3 packs of COCs. They are told to take one pill per day until the first pack is complete and save the remaining 2 packs for possible future use. | Drug | COCR Arm |
Primary outcome
Number of Participants With Implant Continuation
Time frame: 12 months post-insertion
We will assess continuation of use of the contraceptive implant.
1 secondary outcome
Overall Satisfaction With Contraceptive Implant
Time frame: Assessed at 3, 6, and 12 months post-insertion, 12 months reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
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 Ethinyl Estradiol / Norgestimate Oral Tablet in people with Contraception Behavior, run by University of Colorado, Denver 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 3 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 23 Apr 2026. 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 23 Apr 2026). 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 With Implant Continuation (time frame: 12 months post-insertion). 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 23 Apr 2026.