About the DEBI Study
The DEBI trial (DEsogestrel for Bleeding on the Implant) is a trial to assess whether desogestrel is as effective as combined oral contraceptive pill (COCP) in the management of problem bleeding for people with self-reported problem bleeding whilst using the etonogestrel implant. The trial will also assess how cost-effective desogestrel and COCP are as treatments for problem bleeding whilst using the implant.
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, 25% 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 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 participants from UK integrated sexual health clinics and primary care practices offering implant services and will recruit 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.
To best mirror clinical practice, participants will be screened, recruited and randomised into the trial in one visit. Trial treatment - either desogestrel or COCP will be provided in identical packaging. Participants and clinicians will be blinded to participant treatment for the duration of the trial. Participants will be followed up by the Nottingham Clinical Trial Unit (NCTU) trial team for 90 days following randomisation onto the trial.
The DEBI trial is expected to open to recruitment in Aug 2025 and recruitment will run for 17 months total.