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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04558229
Other study ID # MSD201959528
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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