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

Sponsor
University of California, San Diego (Other)
Overall Status
Recruiting
CT.gov ID
NCT04725643
Collaborator
Merck Sharp & Dohme LLC (Industry)
50
Enrollment
1
Location
12
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators will conduct an observational study comparing the number of bleeding days before and after contraceptive implant replacement.

Condition or Disease Intervention/Treatment Phase
  • Device: Track bleeding patterns before and after implant

Detailed Description

There is very limited information regarding number of bleeding days after replacement of the contraceptive implants. 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=50) 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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Keep Contraceptive Arm Long Acting-iMplant (CALM) and Carry On
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Number of bleeding days during 4 weeks before replacement [4 weeks (28 days) before day of implant replacement.]

    Number of days participants experienced bleeding during the 4 weeks before implant replacement.

  2. Number of bleeding days 4 weeks after replacement [4 weeks (28 days) after day of implant replacement]

    Number of days participants experienced bleeding during the 4 weeks after implant replacement.

Secondary Outcome Measures

  1. Satisfaction with bleeding before replacement [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.

  2. Satisfaction with bleeding after replacement [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

  3. Number of bleeding days during the second month after implant replacement [Second month (defined as 29-56 days) after implant replacement]

    Number of days participants experienced bleeding during the second month after implant replacement

  4. Number of bleeding days during the third month post replacement [Third month (defined as 57-84 days) after implant replacement]

    Number of days participants experienced bleeding during the third month after implant replacement

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, San Diego La Jolla California United States 92093

Sponsors and Collaborators

  • University of California, San Diego
  • Merck Sharp & Dohme LLC

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sheila Mody, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT04725643
Other Study ID Numbers:
  • 201908
First Posted:
Jan 27, 2021
Last Update Posted:
Jan 11, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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

Study Results

No Results Posted as of Jan 11, 2022