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

Abstract

Most treatments used to date for endometriosis cause systemic side effects that not only may reduce compliance, but also preclude their long-term use. The levonorgestrel intrauterine system, which delivers the progestogenlevonorgestrel directly into the uterine cavity at a rate of 20 mg daily over 5 years, is an alternative approach that avoids the need for repeated or regular treatment. Side effects are fewer than with oral or depot administration. Women treated with levonorgestrel do not require contraception. This study evaluated levonorgestrel in 34 women 18 to 42 years of age who had laparoscopically confirmed minimal or moderate, symptomatic endometriosis. Participants monitored symptoms and side effects using a diary, a visual analog scale, a verbal rating scale, and a pictorial chart of menstrual blood loss and were followed up at 1, 3, and 6 months and then at 6-month intervals for 3 years. Endometriosis was considered to be minimal in 13 women, mild in 15, and moderate in 6. All but 5 women (85%) retained the device during 6 months, 23 (68%) at 12 months, 21 (62%) at 2 years, and 19 (56%) at 3 years. Withdrawals most often were a consequence of irregular bleeding, mostly in the first 6 months. The next most common reasons were pelvic pain and weight gain. There were no expulsions. Symptom scores, assessed by a visual analog scale, showed a continuous decline up to 30 months and then a slight increase. The difference between preinsertion scores and 6-month scores was statistically significant. Ratings of dysmenorrhea decreased throughout follow-up. Responses could not be related to the stage of disease or to symptom scores. Days of pain during a 28-day interval decreased significantly after 12 months and continued to decline, although at a slower rate. Total blood loss was significantly less after 12 months. Side effects included a case of severe depression, 2 instances of uncomfortable intercourse, and 3 women with simple functional ovarian cysts. These findings support the long-term use of intrauterine progestogen in women with symptomatic endometriosis. No medical treatments offer long-term relief of symptoms to the extent apparent in this trial.