The efficacy, side-effects and continuation rates in women with symptomatic endometriosis undergoing treatment with an intra-uterine administered progestogen (levonorgestrel): a 3 year follow-up

BACKGROUND: Side-effects and choice of drugs influence compliance during treatment for endometriosis. Progestogen administered by a device with a 5-year lifespan, has been shown to be an effective medical alternative with several advantages. The aims of this study were to investigate its efficacy, continuation rates and side-effects in women with endometriosis over a 3-year period. METHODS: Thirty-four women with laparoscopically confirmed minimal to moderate symptomatic endometriosis offered insertion of an intrauterine device at diagnostic laparoscopy were followed up at 1, 3 and 6 months, and then every 6 months for 3 years. A symptom diary for side-effects, documentation of symptoms on a visual analogue scale (VAS), a verbal rating scale (VRS) and quantified menstrual loss using the pictorial blood loss chart was used to assess response to treatment. RESULTS: The continuation rates were respectively 85%, 68%, 62% and 56% at, 6, 12, 24 and 36 months. Discontinuation rates were highest at <12 months, and most of these were for irregular and intolerable bleeding and persistent pain. An improvement in symptoms was observed throughout the 36 months. The greatest changes in pain assessed by either the VAS or VRS were between the pretreatment scores and those after 12 months (7.7+/-1.3 versus 3.5+/-1.8 for VAS, P<0.001; and 25+/-13.8 versus 14+/-9.4 for VRS, P<0.002). The monthly quantified blood loss fell from 204 (196) pretreatment to 60 (50) at 12 months (P<0.001) and then to 70 (30) after 36 months. The most common side-effects were bleeding irregularities (14.7%), one-sided abdominal pain (11.8%) and weight gain (8.8%). CONCLUSIONS: Intrauterine progestogen is effective in symptom control throughout the 3 years on the device, and discontinuation is greatest between 3 and 6 months. For those patients with improvement in symptoms, it is an acceptable long-term alternative.