Phase 4
N=20
Nexplanon and Combined Oral Contraceptive (COC) Combined Use Study
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT02852265 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Number of Participants Evaluating ENG as Acceptable: Acceptability (Measurement: Questionnaire) — 9; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Etonogestrel contraceptive implant (Drug)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Female
- Sponsor
- University of California, Davis
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Evaluating ENG as Acceptable: Acceptability (Measurement: Questionnaire) |
9; 8 | — |
| PRIMARY Number of Participants Evaluating ENG as Tolerable: Tolerability (Measurement: Diaries and Questionnaire) |
2; 0; 1; 0; 1; 0 | — |
| SECONDARY Patient Interest (Measurement: Ability to Enroll) |
10; 10 | — |
| SECONDARY Bleeding Patterns (Measurement: Diaries) |
1; 1; 2; 1; 2; 2 | — |
| SECONDARY COC Continuation Rate (Measurement: Participant Interview) |
6; 5 | — |
| SECONDARY Post-study Method Plan (Measurement: Participant Interview) |
3; 4; 1; 3; 5; 2 | — |
Summary
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.
Eligibility Criteria
Inclusion:
- 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.
Exclusion:
- Women who have contraindications to using a COC or a contraceptive implant (Category 3 or 4 in the CDC Medical Eligibility Criteria) will be excluded.
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Data sourced from ClinicalTrials.gov (NCT02852265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.