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

Sponsor

Planned Parenthood of the St. Louis Region and Southwest Missouri (Other)

Overall Status

Recruiting

CT.gov ID

NCT04558229

Collaborator

Merck Sharp & Dohme LLC (Industry)

348

Enrollment

Location

Arms

37.2

Anticipated Duration (Months)

9.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Birth Control Contraception Contraceptive Usage Family Planning	Other: Additional Standardized Counseling	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

348 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

1:1 fashion with block sizes of 8 using a computer-generated random allocation1:1 fashion with block sizes of 8 using a computer-generated random allocation

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

All study team members will be blinded to the randomization, with the exception of the research member who will be delivering the counseling.

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Nov 24, 2020

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Nexplanon Discontinuation Rates [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Planned Parenthood of the St. Louis Region and Southwest Missouri	Saint Louis	Missouri	United States	63108

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Planned Parenthood of the St. Louis Region and Southwest Missouri

ClinicalTrials.gov Identifier:

NCT04558229

Other Study ID Numbers:

MSD201959528

First Posted:

Sep 22, 2020

Last Update Posted:

Jul 12, 2022

Last Verified:

Jul 1, 2022

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.:

Keywords provided by Planned Parenthood of the St. Louis Region and Southwest Missouri

Contraceptive implant

Birth control

Nexplanon

Additional relevant MeSH terms:

Hemorrhage

Study Results

No Results Posted as of Jul 12, 2022