Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
144 participants
OBSERVATIONAL
2021-12-01
2024-12-01
Brief Summary
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Detailed Description
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Visit 1:
All patients ages 14-24 presenting for contraception services will be screened for potential inclusion. A trained research assistant will conduct a brief patient-centered contraceptive counseling session focusing on patient preferences.
If interested in participating, the patient will be given a card to present to their clinician. During the visit, patient and provider will discuss further method selection including risks, benefits, and alternatives. The clinician will assess for contraindications per the CDC MEC for use of COC or the implant. Screening for pregnancy, sexually transmitted infections, and cervical cancer screening will follow as clinically indicated. If pregnancy test is negative and clinician can be reasonably certain that patient is not pregnant using the CDC Selected Practice Recommendations, the ENG implant will be placed.
After a clinician encounter, the research assistant will consent those interested in participating. Patients will be assigned a unique identification number once they self-select into their exposure group of choice:
1. ENG implant with initiation of concurrent COC use for bleeding control at time of insertion
2. ENG implant alone with option for "delayed initiation" of COC if bleeding concerns develop
Enrolled patients will complete Demographic Questionnaire and Bleeding Preference Questionnaire.
Enrolled patients in exposure group 1 will receive 6 months COC pills (150 mcg levonorgestrel/30 mcg ethinyl estradiol) and condoms for the first week of back-up method. After 6 months, they will be offered a prescription to continue COC pills. Patients in exposure group 2 will be receive handouts describing how to contact the research team should bleeding concerns develop. A telehealth or in-person visit will be arranged with the research clinicians, during which the patient may opt to start COC pills. A 6 month supply will be provided.
Follow-Up:
Follow-up contact will be weekly for the first 6 months. There will also be 9 and 12 month contact.
Each contact will be a brief text-message survey inquiring about bleeding patterns, pill usage and side effects. The ENG implant will be removed upon request at any time during the study.
Study participation will be completed after the 12 month follow-up survey.
No blood draws will occur during this study.
There is little data available on the adverse effects of ENG implant use and combined COC. This is a common clinical practice to combine use for bothersome bleeding and this study will collect long-term data regarding this practice.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1: Same day initiation option
1\) ENG implant with initiation of concurrent COC use for bleeding control at time of insertion
150 mcg levonorgestrel/30 mcg ethinyl estradiol
concurrent use of COC with Nexplanon
Group 2: Delayed initiation option
2\) ENG implant alone with option for "delayed initiation" of COC if bleeding concerns develop
150 mcg levonorgestrel/30 mcg ethinyl estradiol
concurrent use of COC with Nexplanon
Interventions
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150 mcg levonorgestrel/30 mcg ethinyl estradiol
concurrent use of COC with Nexplanon
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
14 Years
24 Years
FEMALE
Yes
Sponsors
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Organon
INDUSTRY
University of Arizona
OTHER
Responsible Party
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Holly Bullock
Assistant Professor, Department of OBGYN
Central Contacts
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Other Identifiers
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IRB 2104687928
Identifier Type: -
Identifier Source: org_study_id