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

NCT04558229 | Active Not Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: MSD201959528
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Contraceptive implant; Birth control; Nexplanon

Outcome Measures

Primary Outcomes (1)

• Nexplanon Discontinuation Rates

  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

Study Arms (2)

Standard of Care Clinician Counseling

NO INTERVENTION

Additional Standardized Counseling

EXPERIMENTAL

Other: Additional Standardized Counseling

Interventions

Additional Standardized Counseling OTHER

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.

Additional Standardized Counseling

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Cis-gendered females; Assigned female at birth and not using hormone therapy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Presenting at the health center to receive an etonogestrel-releasing subdermal implant (Nexplanon) for primarily contraceptive benefits
• Ability to consent in English

You may not qualify if:

• Have used an etonogestrel-releasing subdermal implant (Nexplanon) within the 12 weeks prior to enrollment

Sponsors & Collaborators

• Planned Parenthood of the St. Louis Region and Southwest Missouri: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Planned Parenthood of the St. Louis Region and Southwest Missouri

St Louis, Missouri, 63108, United States

Location

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Study Officials

• Colleen P McNicholas, DO, MSCI

  Planned Parenthood of the St. Louis Region and Southwest Missouri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: All study team members will be blinded to the randomization, with the exception of the research member who will be delivering the counseling.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 fashion with block sizes of 8 using a computer-generated random allocation

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 22, 2020
• Study Start: November 24, 2020
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

US (1)