RCT Evaluating Standardized Counseling on Early Discontinuation for Irregular Bleeding in Nexplanon Users

May 29, 2025 updated by: Planned Parenthood of the St. Louis Region and Southwest Missouri

Randomized Control Trial Evaluating Impact of Standardized Counseling on Early Discontinuation for Irregular Bleeding in Users of the Contraceptive Implant

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

348

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63108
        • Planned Parenthood of the St. Louis Region and Southwest Missouri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care Clinician Counseling
Experimental: Additional Standardized Counseling
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nexplanon Discontinuation Rates
Time Frame: 6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Planned Parenthood of the St. Louis Region and Southwest Missouri

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Colleen P McNicholas, DO, MSCI, Planned Parenthood of the St. Louis Region and Southwest Missouri

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2020

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

September 15, 2020

First Submitted That Met QC Criteria

September 15, 2020

First Posted (Actual)

September 22, 2020

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

May 29, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSD201959528

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Contraception

Clinical Trials on Additional Standardized Counseling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe