A Phase 4 interventional study of Ethinyl Estradiol / Norgestimate Oral Tablet in Contraception Behavior, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to female participants aged 14 Years to 23 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by University of Colorado, Denver · Phase 4, Interventional, and Treatment
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).
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:
132 studies on the registry are indexed under Contraception Behavior; 20 are open to participants now.
This study's enrollment of 600 is above the median of 382 across 106 interventional studies indexed under Contraception Behavior.
Browse Contraception Behavior studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Ethinyl Estradiol / Norgestimate Oral Tablet
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.
Drug pages: Ethinyl Estradiol · Norgestimate
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.
Number of Participants With Implant Continuation
We will assess continuation of use of the contraceptive implant.
Time frame: 12 months post-insertion
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.
Time frame: Assessed at 3, 6, and 12 months post-insertion, 12 months reported
Implant-related Health Care Interactions
We will assess the number of healthcare interactions (phone calls, visits, messages, prescription refills) that are related to the use of the contraceptive implant or oral contraceptives dispensed in this study using the electronic medical record system.
Time frame: within 12 months of insertion
| Milestone | COCR Arm | SOC Arm |
|---|---|---|
| Started | 300 | 300 |
| Completed | 282 | 283 |
| Not completed | 18 | 17 |
We will assess continuation of use of the contraceptive implant.
| Participants | COCR Arm | SOC Arm |
|---|---|---|
| Number of Participants With Implant Continuation | 219 | 225 |
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.
| Participants | COCR Arm | SOC Arm |
|---|---|---|
| Very dissatisfied | 11 | 9 |
| Somewhat dissatisfied | 16 | 16 |
| Not satisfied or dissatisfied | 24 | 20 |
| Somewhat satisfied | 64 | 73 |
| Very satisfied | 85 | 94 |
We will assess the number of healthcare interactions (phone calls, visits, messages, prescription refills) that are related to the use of the contraceptive implant or oral contraceptives dispensed in this study using the electronic medical record system.
| Interactions | COCR Arm | SOC Arm |
|---|---|---|
| Implant-related Health Care Interactions | 0 (0 to 3) | 0 (0 to 3) |
Collected over 1 Year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| COCR Arm | 0/300 (0%) | 0/300 (0%) | 0/300 (0%) |
| SOC Arm | 0/300 (0%) | 0/300 (0%) | 0/300 (0%) |
| Age, Categorical(Participants) | COCR Arm | SOC Arm | Total |
|---|---|---|---|
| <=18 years | 111 | 116 | 227 |
| Between 18 and 65 years | 189 | 184 | 373 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(Years) | COCR Arm | SOC Arm | Total |
|---|---|---|---|
| Median | 18.7 (14.1 to 23.9) | 18.6 (14.0 to 23.9) | 18.6 (14.0 to 23.9) |
| Sex: Female, Male(Participants) | COCR Arm | SOC Arm | Total |
|---|---|---|---|
| Female | 300 | 300 | 600 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | COCR Arm | SOC Arm | Total |
|---|---|---|---|
| Hispanic or Latino | 156 | 170 | 326 |
| Not Hispanic or Latino | 122 | 103 | 225 |
| Unknown or Not Reported | 22 | 27 | 49 |
| Race (NIH/OMB)(Participants) | COCR Arm | SOC Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 11 | 5 | 16 |
| Asian | 10 | 19 | 29 |
| Native Hawaiian or Other Pacific Islander | 2 | 6 | 8 |
| Black or African American | 43 | 28 | 71 |
| White | 152 | 135 | 287 |
| More than one race | 29 | 40 | 69 |
| Unknown or Not Reported | 53 | 67 | 120 |
| Region of Enrollment(participants) | COCR Arm | SOC Arm | Total |
|---|---|---|---|
| United States | 300 | 300 | 600 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Jun 2021 to primary completion in Nov 2025, 52 months.
Results were first posted in Apr 2026, 5 months after primary completion.
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Studies of the drugs tested here: Ethinyl Estradiol · Norgestimate
University of Colorado, Denver →