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NCT04558229 · ClinicalTrials.gov registry record · Phase 4
RCT Evaluating Standardized Counseling on Early Discontinuation for Irregular Bleeding in Nexplanon Users
A Phase 4 study of Contraception and Contraceptive Usage, sponsored by Planned Parenthood of the St. Louis Region and Southwest Missouri.
- Active
- Registry status
- Phase 4
- Development phase
- 348
- Enrollment target
- 1
- Study location
NCT04558229: Active Phase 4 study of Contraception and Contraceptive Usage, sponsored by Planned Parenthood of the St. Louis Region and Southwest Missouri.
NCT04558229 is a Phase 4 study of Contraception and Contraceptive Usage that is active but no longer recruiting, run by Planned Parenthood of the St. Louis Region and Southwest Missouri. The registered enrollment target is 348 participants, below the 450-participant average among 72 other Contraception trials with a reported enrollment target (23% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04558229, a Phase 4 study of Contraception and Contraceptive Usage, is active but no longer recruiting, sponsored by Planned Parenthood of the St. Louis Region and Southwest Missouri.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 348 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Based subjects' self-reported ability to cope with various changes in bleeding patterns, and other demographic information, we will analyze whether an association exists between those who discontinue their method use early due to troublesome bleeding and the counseling they received on the day of method insertion.
Conditions Studied
Interventions
- OTHER Additional Standardized Counseling
Study Locations (1)
Missouri
- Planned Parenthood of the St. Louis Region and Southwest Missouri - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 348 participants |
| Start Date | 2020-11-24 |
| Est. Completion | 2025-12-30 |
| Phase | Phase 4 |
What the registry record for NCT04558229 still lists
NCT04558229 is an interventional study that assigns participants to a tested intervention. The registered 348 participants enrollment target is mid-sized for trials with a published cap, below the 450-participant average among 72 other Contraception trials with a reported enrollment target (23% lower).
The record links to 4 conditions, with Contraception appearing as the primary indexed condition, and to 1 intervention - of which Additional Standardized Counseling is the first listed.
NCT04558229 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT04558229 about?
NCT04558229 is a clinical study titled "RCT Evaluating Standardized Counseling on Early Discontinuation for Irregular Bleeding in Nexplanon Users". 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...
What is the current status of trial NCT04558229?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 348 participants. The study started on 2020-11-24. Estimated completion is 2025-12-30.
What conditions does trial NCT04558229 study?
This clinical trial studies the following conditions: Contraception, Contraceptive Usage, Family Planning, Birth Control.
What interventions are being tested in trial NCT04558229?
The interventions under investigation include: Additional Standardized Counseling (OTHER).
Who is sponsoring clinical trial NCT04558229?
This trial is sponsored by Planned Parenthood of the St. Louis Region and Southwest Missouri, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04558229 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Contraception
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04558229's enrollment target sits among peer trials
348 26th of 72 higher than 47 of 72 other Contraception trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Contraception trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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