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Trial record 3 of 165 for:    tenaya

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

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 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 : November 24, 2020
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Cis-gendered females; Assigned female at birth and not using hormone therapy
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04558229


Contacts
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Contact: Loire Biggs 3145317526 ext 384 loire.biggs@ppslr.org
Contact: Tenaya Drapkin, MSW 3145317526 ext 362 tenaya.drapkin@ppslr.org

Locations
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United States, Missouri
Planned Parenthood of the St. Louis Region and Southwest Missouri Recruiting
Saint Louis, Missouri, United States, 63108
Contact: Loire Biggs    314-531-7526 ext 384    loire.biggs@ppslr.org   
Principal Investigator: Colleen P McNicholas, DO, MSCI         
Sponsors and Collaborators
Planned Parenthood of the St. Louis Region and Southwest Missouri
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Colleen P McNicholas, DO, MSCI Planned Parenthood of the St. Louis Region and Southwest Missouri
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Responsible Party: Planned Parenthood of the St. Louis Region and Southwest Missouri
ClinicalTrials.gov Identifier: NCT04558229    
Other Study ID Numbers: MSD201959528
First Posted: September 22, 2020    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: April 2021

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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
Keywords provided by Planned Parenthood of the St. Louis Region and Southwest Missouri:
Contraceptive implant
Birth control
Nexplanon
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes