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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Nexplanon Discontinuation Rates

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
3,887 Previous Clinical Trials
5,054,346 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I qualified to participate in the research endeavor?

"To be accepted into this experiment, applicants must have established a family and fall between 18 to 40 years of age. The trial aims to enrol 348 individuals in total."

Answered by AI

How many participants is this research endeavor recruiting?

"Affirmative. According to the clinicaltrials.gov website, this medical experiment is currently seeking participants and was first posted on November 24th 2020. A total of 348 patients are needed from a single centre and the study has been updated most recently as of July 11th 2022."

Answered by AI

Has the FDA sanctioned any additional forms of counseling as a treatment?

"Additional Standardized Counseling has already been authorized for public use, and our team at Power estimates its safety to be a 3 on the scale."

Answered by AI

Are there any openings still available for this medical research?

"According to the clinicaltrials.gov portal, this medical investigation is still searching for participants. The trial was originally posted on November 24th 2020 and underwent a recent update July 11th 2022."

Answered by AI

Does this experiment extend to geriatric individuals?

"According to the clinical trial's parameters, only individuals aged 18 to 40 are eligible. There is a total of 81 studies that accept younger participants and 309 trials for seniors over 65 years old."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Planned Parenthood of the St. Louis Region and Southwest Missouri
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
RCT Evaluating Standardized Counseling on Early Discontinuation for Irregular Bleeding in Nexplanon Users
2020. "RCT Evaluating Standardized Counseling on Early Discontinuation for Irregular Bleeding in Nexplanon Users". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04558229.
~51 spots leftby Nov 2024
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