DEsogestrel for Bleeding on the Implant (DEBI)
Research type
Research Study
Full title
Clinical and cost-effectiveness of desogestrel versus the combined oral contraceptive pill for problematic bleeding on the etonogestrel implant: DEBI trial
IRAS ID
1007190
Contact name
Kate Walker
Contact email
Sponsor organisation
University of Nottingham
ISRCTN Number
ISRCTN10116165
Research summary
The contraceptive implant (68mg etonogestrel) is a hormone containing rod that is placed under the skin of the arm and is more than 99% effective at preventing pregnancy. Unfortunately, 24% of users have the implant removed early due to frustrating and unpredictable changes in their periods. Bad experiences with the implant deter people from using other effective contraceptive methods and may increase the risk of unintended pregnancy.
The current first line treatment that is recommended is to take the combined oral contraceptive pill (COCP).
This research aims to see whether desogestrel is as good as COCP in reducing problematic bleeding while using the implant. Desogestrel is slightly safer and cheaper than the combined pill, can be used in people who cannot take the combined pill and can be bought without a prescription. Using desogestrel means that people are only exposed to one type of hormone rather than two in the combined oral contraceptive pill. People taking the combined pill require annual blood pressure and weight monitoring, which is not required with desogestrel. If desogestrel is found to be as good as the combined pill it will mean a safer, cheaper, more accessible treatment for problematic bleeding on the implant.
The trial will recruit 690 menstruating people aged 16-45 with self-reported problem bleeding whilst using the etonogestrel implant. Problem bleeding is defined as bleeding of any type (e.g. spotting/heavy) considered problematic by the person. They must be willing to complete a daily bleeding diary for the trial duration.
The research aims to see whether desogestrel is as good as the combined oral contraceptive pill in settling problem bleeding during a 90-day period for people with problem bleeding whilst using the etonogestrel implant. Resolution of problem bleeding is defined as people self-reporting significant improvement in the bleeding pattern during the 90-day reference period.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
25/NW/0110
Date of REC Opinion
8 May 2025
REC opinion
Further Information Favourable Opinion