NCT04558229

RCT Evaluating Standardized Counseling on Early Discontinuation 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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 348 (estimated)
• Sponsor: Planned Parenthood of the St. Louis Region and Southwest Missouri · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Clinician counseling for implant users should involve an explanation of the likelihood of irregular bleeding and the possibility of continued or frequent bleeding throughout three years of use. If that counseling does not provide specifics of the actual distribution of bleeding patterns described in published literature, there remains the real possibility of biased or directed counseling, leading to an inaccurate and exaggerated expectation of potential bleeding changes. This study aims to evaluate if a standardized script accompanied by a visual aid regarding expected bleeding profiles, with intention to remove any possibility of negative or positive framing, could change users' expectations and satisfaction with their method, leading to lower discontinuation rates.

Conditions

• Birth Control
• Contraception
• Contraceptive Usage
• Family Planning

Interventions

Type	Name	Description
OTHER	Additional Standardized Counseling	Research staff will follow a script designed to give unbiased, medically accurate information regarding bleeding changes that may occur with use of a contraceptive ENG implant.

Timeline

• Start date: 2020-11-24
• Primary completion: 2025-11-30
• Completion: 2025-12-30
• First posted: 2020-09-22
• Last updated: 2025-06-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study