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Standardized Counseling for Irregular Bleeding in Birth Control Users

Phase 4
Recruiting
Led By Colleen P McNicholas, DO, MSCI
Research Sponsored by Planned Parenthood of the St. Louis Region and Southwest Missouri
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presenting at the health center to receive an etonogestrel-releasing subdermal implant (Nexplanon) for primarily contraceptive benefits
Be between 18 and 65 years old
Must not have
Have used an etonogestrel-releasing subdermal implant (Nexplanon) within the 12 weeks prior to enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing whether a standardized script, accompanied by a visual aid, about expected bleeding profiles could change users' expectations and satisfaction with their method, leading to lower discontinuation rates.

Who is the study for?
This trial is for individuals seeking to use the Nexplanon implant for birth control and can consent in English. It's not open to those who've used Nexplanon within the last 12 weeks.
What is being tested?
The study tests whether a standardized counseling script with visuals about expected bleeding patterns from using Nexplanon affects users' satisfaction and reduces early discontinuation of the implant.
What are the potential side effects?
While this trial focuses on counseling rather than medication, irregular bleeding is a known side effect of using the Nexplanon contraceptive implant.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am getting a Nexplanon implant for birth control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have used a Nexplanon implant in the last 12 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Nexplanon Discontinuation Rates

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Additional Standardized CounselingExperimental Treatment1 Intervention
Group II: Standard of Care Clinician CounselingActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Planned Parenthood of the St. Louis Region and Southwest MissouriLead Sponsor
2 Previous Clinical Trials
391 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,032 Previous Clinical Trials
5,189,368 Total Patients Enrolled
Colleen P McNicholas, DO, MSCIPrincipal InvestigatorPlanned Parenthood of the St. Louis Region and Southwest Missouri

Media Library

Additional Standardized Counseling Clinical Trial Eligibility Overview. Trial Name: NCT04558229 — Phase 4
Birth Control Research Study Groups: Additional Standardized Counseling, Standard of Care Clinician Counseling
Birth Control Clinical Trial 2023: Additional Standardized Counseling Highlights & Side Effects. Trial Name: NCT04558229 — Phase 4
Additional Standardized Counseling 2023 Treatment Timeline for Medical Study. Trial Name: NCT04558229 — Phase 4
~68 spots leftby Dec 2025
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