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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etonogestrel contraceptive implant | Drug | Place nexplanon |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Bleeding Patterns (Measurement: Diaries) |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell Creinin, MD | Univeristy of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29496473 | Derived | 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. |
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We consented and enrolled 20 women in the outpatient clinic at the University of California, Davis Department of Obstetrics and Gynecology for study participation between September and December 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | New Start COC Users | Women who are starting or recently started (within last 4 weeks) a combined oral contraceptive |
| FG001 | Continuing COC Users | Women who have been using a combined oral contraceptive for more than 4 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1-month Follow-up |
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| 3-month Follow-up |
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| 6-month Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | New Start COC Starters | Women who are starting or recently started (within last 4 weeks) a combined oral contraceptive |
| BG001 | Continuing COC Users | Women who have been using a combined oral contraceptive for more than 4 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 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 | All women enrolled in study | Posted | Count of Participants | Participants | 6 months |
|
6 months of follow-up
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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 | New Start COC Users | Women who are starting or recently started (within last 4 weeks) a combined oral contraceptive |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nexplanon removal | Surgical and medical procedures | Systematic Assessment | removal of implant |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Melissa Chen | University of California, Davis | 916-734-6670 | mejchen@ucdavis.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 | Aug 12, 2016 | Apr 30, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C044815 | etonogestrel |
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Bleeding patterns while using a COC concomitantly with ENG implant
| 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 | 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 | 6 months |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Pill type | Count of Participants | Participants |
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| Primary | 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 | All enrolled subjects, new or worsening side effects after 6 months of use in women using both an implant and a COC | Posted | Number | participants | 6 months |
|
|
|
| Secondary | 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 | women using or starting a COC and having an etonogestrel implant placed; 1 lost to follow-up in each group from enrollment (n=10 in both groups at enrollment) | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Bleeding Patterns (Measurement: Diaries) | Bleeding patterns while using a COC concomitantly with ENG implant | women using or starting a COC and having an etonogestrel implant placed; 1 lost to follow-up in each group from enrollment (n=10 in both groups at enrollment) | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | 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 | women using or starting a COC and having an etonogestrel implant placed; 1 lost to follow-up in each group from enrollment (n=10 in both groups at enrollment) | Posted | Count of Participants | Participants | 6 months |
|
|
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| Secondary | Post-study Method Plan (Measurement: Participant Interview) | Plan to continue the COC and/or implant after the study based on interview at last visit | women using or starting a COC and having an etonogestrel implant placed; 1 lost to follow-up in each group from enrollment (n=10 in both groups at enrollment) | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | Continuing COC Users | Women who have been using a combined oral contraceptive for more than 4 weeks | 0 | 10 | 0 | 10 | 1 | 10 |
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| mastalgia |
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| mood complaints |
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| worsening acne |
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| worsening dysmenorrhea |
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| weight gain |
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| irregular 1st 90 days |
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| infrequent 1st 90 days |
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| amenorrhea 1st 90 days |
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| regular 1st 90 days |
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| prolonged 2nd 90 days |
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| frequent 2nd 90 days |
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| irregular 2nd 90 days |
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| infrequent 2nd 90 days |
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| amenorrhea 2nd 90 days |
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| regular 2nd 90 days |
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| using implant and COC |
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| not using implant or COC |
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