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

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ClinicalTrials.gov Identifier: NCT04558229
Recruitment Status : Recruiting
First Posted : September 22, 2020
Last Update Posted : April 12, 2021
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Planned Parenthood of the St. Louis Region and Southwest Missouri

Tracking Information
First Submitted Date  ICMJE September 15, 2020
First Posted Date  ICMJE September 22, 2020
Last Update Posted Date April 12, 2021
Actual Study Start Date  ICMJE November 24, 2020
Estimated Primary Completion Date November 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RCT Evaluating Standardized Counseling on Early Discontinuation for Irregular Bleeding in Nexplanon Users
Official Title  ICMJE Randomized Control Trial Evaluating Impact of Standardized Counseling on Early Discontinuation for Irregular Bleeding in Users of the Contraceptive Implant
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
1:1 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
Condition  ICMJE
  • Birth Control
  • Contraception
  • Contraceptive Usage
  • Family Planning
Intervention  ICMJE 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.
Study Arms  ICMJE
  • No Intervention: Standard of Care Clinician Counseling
  • Experimental: Additional Standardized Counseling
    Intervention: Other: Additional Standardized Counseling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 15, 2020)
348
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2023
Estimated Primary Completion Date November 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Cis-gendered females; Assigned female at birth and not using hormone therapy
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Loire Biggs 3145317526 ext 384 loire.biggs@ppslr.org
Contact: Tenaya Drapkin, MSW 3145317526 ext 362 tenaya.drapkin@ppslr.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04558229
Other Study ID Numbers  ICMJE MSD201959528
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Planned Parenthood of the St. Louis Region and Southwest Missouri
Study Sponsor  ICMJE Planned Parenthood of the St. Louis Region and Southwest Missouri
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator: Colleen P McNicholas, DO, MSCI Planned Parenthood of the St. Louis Region and Southwest Missouri
PRS Account Planned Parenthood of the St. Louis Region and Southwest Missouri
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP