Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Contraception
  • Contraceptive Usage
  • Family Planning
Type
Observational
Design
Observational Model: OtherTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 50 years
Gender
Only males

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 w...

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.

Tracking Information

NCT #
NCT04725643
Collaborators
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Sheila Mody, MD, MPH University of California, San Diego