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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethinyl Estradiol / Norgestimate Oral Tablet | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Implant Continuation | We will assess continuation of use of the contraceptive implant. | 12 months post-insertion |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed at 3, 6, and 12 months post-insertion, 12 months reported |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within 12 months of insertion |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | COCR Arm | 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. Ethinyl Estradiol / Norgestimate Oral Tablet: 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. |
| FG001 | SOC Arm | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | COCR Arm | 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. Ethinyl Estradiol / Norgestimate Oral Tablet: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Implant Continuation | We will assess continuation of use of the contraceptive implant. | Posted | Count of Participants | Participants | 12 months post-insertion |
|
1 Year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | COCR Arm | 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. Ethinyl Estradiol / Norgestimate Oral Tablet: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jeanelle Sheeder | University of Colorado | (303)724-2272 | JEANELLE.SHEEDER@CUANSCHUTZ.EDU |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 7, 2025 | Feb 3, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003268 | Contraception Behavior |
| ID | Term |
|---|---|
| D043762 | Reproductive Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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|
| BG001 | SOC Arm | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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.
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Assessed at 3, 6, and 12 months post-insertion, 12 months reported |
|
|
|
| Other Pre-specified | 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. | Posted | Median | Full Range | Interactions | within 12 months of insertion |
|
|
|
| 0 |
| 300 |
| 0 |
| 300 |
| 0 |
| 300 |
| EG001 | SOC Arm | 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. | 0 | 300 | 0 | 300 | 0 | 300 |
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| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Not satisfied or dissatisfied |
|
| Somewhat satisfied |
|
| Very satisfied |
|