DEBI: clinical and cost-effectiveness of desogestrel versus the combined oral contraceptive pill for problematic bleeding on the etonogestrel implant

QUESTION Is desogestrel, a progestogen only contraceptive pill, non-inferior to the combined oral contraceptive pill (COCP; containing estrogen and progestogen) for women with problematic bleeding whilst using the etonogestrel implant? BACKGROUND The etonogestrel implant is the most effective (failure rate 0.05%) and popular method of long-acting reversible contraceptives (LARC) in the UK (40% LARC, 18% all contraception).(1, 2) Unfortunately, it has the least favourable bleeding pattern of all LARC methods. Problematic bleeding experienced by 24% of users, is the most common reason for discontinuation. 25% of users who discontinue early do so because of problematic bleeding. (3-6). Current evidence for the best treatment for problematic bleeding whilst using the implant is limited. The COCP has the most evidence and is recommended first line in national guidelines. However, COCP has many contraindications. One popular unevidenced option is desogestrel, a progestogen contraceptive only pill, because it does not have the same risks and contraindications as COCP. OBJECTIVES 1. To establish whether desogestrel is non-inferior to the COCP for women with problematic bleeding whilst using the etonogestrel implant, by conducting a randomised controlled trial. 2. To measure and value health care resource use associated with desogestrel or COCP for problematic bleeding by conducting a trial-based economic evaluation. 3. To conduct an internal pilot to evaluate key trial processes to inform progression from pilot phase to main trial. METHODS We have designed a clinician and participant blinded non-inferiority, randomised controlled trial of desogestrel versus COCP for problematic bleeding whilst using the implant. It will also assess the acceptability, safety and cost effectiveness of both desogestrel and COCP as treatment options. TIMELINES (MONTHS) Total duration: 40 1-11 set-up, 12-18 sites open to recruitment, 21 internal pilot assessment, 31 complete data collection, 33-40 complete analyses, reporting and dissemination IMPACT The results will inform national and international guidelines, which support clinicians providing sexual and reproductive healthcare (SRH) to offer evidence-based treatments. The results will help patients choose the best treatment option for their needs. For all patients and particularly individuals with contraindications to COCP if the results confirm desogestrel is an effective treatment, they will have access to an evidence-based treatment for the first time. Improvement in bleeding patterns may reduce discontinuation of the implant for problematic bleeding, reduce impact on daily living activities as well as potential for reduced unplanned pregnancies and termination of pregnancy. DISSEMINATION • Findings will be disseminated via a published HTA journal, research papers published in high-impact peer review journals (e.g., NEJM) and presentation at medical and nursing conferences nationally and internationally e.g., Faculty of Sexual and Reproductive Healthcare?(FSRH) annual scientific meeting • Results presented in a plain English summary which will be sent to the participants via their preferred communication method. • Findings disseminated among people via Reproductive Justice Initiative, CERT, our PPI groups and social media. Innovative methods such as infographics and animations used to illustrate the findings.