Keep Contraceptive Arm Long Acting-iMplant (CALM) and Carry On (CALM)

January 19, 2024 updated by: Sheila Mody, University of California, San Diego
The investigators will conduct an observational study comparing the number of bleeding days before and after contraceptive implant (Nexplanon) replacement.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

There is very limited information regarding number of bleeding days after replacement of the contraceptive implants (Nexplanon). More detailed information on this topic will help clinicians counsel patients and help women decide if they would like to pursue contraceptive implant replacement.

The investigators will conduct a prospective cohort study of (N=114) among women replacing their contraceptive implant. The primary outcome of the study is the difference in number of bleeding days between the 4-week periods before and after implant replacement. Secondary outcomes include satisfaction with bleeding. Additionally, a secondary outcome will be the number of bleeding days in month 2 and month 3 after replacement of the contraceptive implant. The outcomes will be measured in bleeding diaries and satisfaction surveys.

Through a text messaging application, the investigators will send the participants hyperlinks to the diaries/surveys at the stated time points. Participants will report if they had bleeding and the amount based on the Pictorial Blood Assessment Chart (Higham). Participants will complete weekly surveys regarding their satisfaction with their bleeding utilizing a Likert scale. The investigators will also ask participants to complete a survey regarding their satisfaction with their bleeding at end of month 2 and at the end of month 3 after replacement of their contraceptive implant.

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • University of California, San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled at UC San Diego for a contraceptive implant after approximately 3 years (32-40 months) of use.

Description

Inclusion Criteria:

  • Reproductive aged women 18-50 years old
  • With a contraceptive implant (for patient participants)
  • Able to consent in English
  • Palpable contraceptive implant

Exclusion Criteria:

  • Non-palpable contraceptive implant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Implant Group
Adults who are choosing to get a replacement Nexplanon and agree to track and report their bleeding patterns for one month before replacement and 3 months after.
Device: Track bleeding patterns before and after implant
Participants will report if they had bleeding and the amount based on the Pictorial Blood Assessment Chart. Participants will also complete weekly surveys regarding their satisfaction with their bleeding. We will also ask participants to complete a survey regarding their satisfaction with their bleeding at end of month 2 and at the end of month 3 after replacement of their contraceptive implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of bleeding days during 4 weeks before replacement
Time Frame: 4 weeks (28 days) before day of implant replacement.
Number of days participants experienced bleeding during the 4 weeks before implant replacement.
4 weeks (28 days) before day of implant replacement.
Number of bleeding days 4 weeks after replacement
Time Frame: 4 weeks (28 days) after day of implant replacement
Number of days participants experienced bleeding during the 4 weeks after implant replacement.
4 weeks (28 days) after day of implant replacement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with bleeding before replacement
Time Frame: 4 weeks (28 days) before day of implant replacement
Using a 1-5 Likert scale with 1=Not Satisfied and 5=Very Satisfied, participants will report satisfaction with their bleeding before implant replacement.
4 weeks (28 days) before day of implant replacement
Satisfaction with bleeding after replacement
Time Frame: 4 weeks (28 days) after day of implant replacement
Using a 1-5 Likert scale with 1=Not Satisfied and 5=Very Satisfied, participants will report satisfaction with their bleeding after replacement
4 weeks (28 days) after day of implant replacement
Number of bleeding days during the second month after implant replacement
Time Frame: Second month (defined as 29-56 days) after implant replacement
Number of days participants experienced bleeding during the second month after implant replacement
Second month (defined as 29-56 days) after implant replacement
Number of bleeding days during the third month post replacement
Time Frame: Third month (defined as 57-84 days) after implant replacement
Number of days participants experienced bleeding during the third month after implant replacement
Third month (defined as 57-84 days) after implant replacement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Sheila Mody, MD, MPH, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2022

Primary Completion (Actual)

January 11, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 16, 2020

First Submitted That Met QC Criteria

January 22, 2021

First Posted (Actual)

January 27, 2021

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 201908

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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