Comparing contraceptive implant discontinuation rates with and without additional support
Reduction of Premature Discontinuation of Contraceptive Implants by Advance Provision of an OCP-based Participant Intervention: Randomized Clinical Trial
This study is testing if young women aged 14 to 22.9 who get extra support, like advance contraceptive pills, are less likely to stop using their contraceptive implants compared to those who only receive standard counseling.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 14 Years to 23 Years |
| Sex | Female |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT04828824 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the rates of discontinuation of etonogestrel contraceptive implants among young women aged 14 to 22.9 years who receive advance provision of combined oral contraceptive pills and a bleeding rescue regimen versus those who receive standard counseling. The primary objective is to assess whether the additional support leads to lower discontinuation rates. Secondary objectives include evaluating participant satisfaction and the need for clinical follow-up in the year following implant initiation.
Who should consider this trial
Good fit: Ideal candidates are young women aged 14 to 22.9 years who are initiating the etonogestrel implant for the first time.
Not a fit: Patients who have contraindications to estrogen-containing birth control or those planning to become pregnant within the next 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved retention rates of contraceptive implants and higher satisfaction among users.
How similar studies have performed: While there is limited data on this specific approach, similar studies have shown that additional support can improve contraceptive adherence and satisfaction.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. You are between ages of 14 to 22.9 years. 2. Started etonogestrel implant for the first time and have never used the implant before. Exclusion Criteria: 1. There is any contraindication to estrogen containing birth control. 2. Desire of pregnancy in next 12 months. 3. Plans to move from the area in next 12 months and is not able to come to the clinic.
Where this trial is running
Aurora, Colorado
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Jeanelle Sheeder, PhD
- Email: jeanelle.sheeder@cuanschutz.edu
- Phone: (303) 724-2272
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.