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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04558229
• Other study ID #: MSD201959528
• Status: Recruiting
• Phase: Phase 4
• Start date: November 24, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: January 2024
• Source: Planned Parenthood of the St. Louis Region and Southwest Missouri
• Contact: Loire Biggs
• Phone: 3145317526
• Email: loire.biggs[@]ppslr.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 348
• Est. completion date: June 30, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Birth Control
• Contraception
• Contraceptive Usage
• Family Planning
• Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
United States	Planned Parenthood of the St. Louis Region and Southwest Missouri	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Planned Parenthood of the St. Louis Region and Southwest Missouri	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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