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

NCT04725643 | Unknown FDA Device

• 1 other identifier: 201908
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Contraception; Contraceptive Usage; Family Planning

Keywords

Nexplanon, Contraceptive implant

Outcome Measures

Primary Outcomes (2)

• Number of bleeding days during 4 weeks before 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

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

  4 weeks (28 days) after day of implant replacement

Secondary Outcomes (4)

• Satisfaction with bleeding before replacement

  4 weeks (28 days) before day of implant replacement

• Satisfaction with bleeding after replacement

  4 weeks (28 days) after day of implant replacement

• Number of bleeding days 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

  Third month (defined as 57-84 days) after implant replacement

Study Arms (1)

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

Interventions

Track bleeding patterns before and after implant DEVICE

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.

Implant Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• Non-palpable contraceptive implant

Sponsors & Collaborators

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

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Related Publications (1)

• Higham JM, O'Brien PM, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol. 1990 Aug;97(8):734-9. doi: 10.1111/j.1471-0528.1990.tb16249.x.

  PMID: 2400752 BACKGROUND

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Study Officials

• Sheila Mody, MD, MPH

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: January 27, 2021
• Study Start: February 17, 2022
• Primary Completion: January 11, 2024
• Study Completion: December 31, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)