Evaluating counseling for irregular bleeding in Nexplanon users
Randomized Control Trial Evaluating Impact of Standardized Counseling on Early Discontinuation for Irregular Bleeding in Users of the Contraceptive Implant
PHASE4 · Planned Parenthood of the St. Louis Region and Southwest Missouri · NCT04558229
This study tests if providing clear counseling about irregular bleeding can help women using the Nexplanon implant feel more satisfied and continue using it longer.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 348 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Planned Parenthood of the St. Louis Region and Southwest Missouri (other) |
| Locations | 1 site (Saint Louis, Missouri) |
| Trial ID | NCT04558229 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of standardized counseling for users of the Nexplanon contraceptive implant, focusing on the likelihood of experiencing irregular bleeding. The approach involves providing a standardized script and visual aids to convey accurate information about expected bleeding patterns, aiming to reduce biased counseling. By addressing user expectations and satisfaction, the study seeks to lower the rates of discontinuation of the contraceptive method. Participants will be women seeking the Nexplanon implant for contraception who can consent in English.
Who should consider this trial
Good fit: Ideal candidates are women seeking the Nexplanon implant for contraceptive purposes who can understand and consent to counseling in English.
Not a fit: Patients who have used Nexplanon within the last 12 weeks will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved satisfaction and lower discontinuation rates among Nexplanon users.
How similar studies have performed: Other studies have shown that standardized counseling can improve patient outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Presenting at the health center to receive an etonogestrel-releasing subdermal implant (Nexplanon) for primarily contraceptive benefits * Ability to consent in English Exclusion Criteria: * Have used an etonogestrel-releasing subdermal implant (Nexplanon) within the 12 weeks prior to enrollment
Where this trial is running
Saint Louis, Missouri
- Planned Parenthood of the St. Louis Region and Southwest Missouri — Saint Louis, Missouri, United States (RECRUITING)
Study contacts
- Principal investigator: Colleen P McNicholas, DO, MSCI — Planned Parenthood of the St. Louis Region and Southwest Missouri
- Study coordinator: Loire Biggs
- Email: loire.biggs@ppslr.org
- Phone: 3145317526
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.
Conditions: Birth Control, Contraception, Contraceptive Usage, Family Planning, Contraceptive implant, Birth control, Nexplanon