Clinical performance of a levonorgestrel-releasing intracervical contraceptive device during the first year of use

Abstract

One-hundred-and-ninety-eight women used a new type of levonorgestrel-releasing intracervical contraceptive device (LNG-ICD) designed to release 20 micrograms levonorgestrel/day. The insertion took place within 7 days of menstruation. Clinical performance during the first year of LNG-ICD use was evaluated. Seven pregnancies occurred during the study period; one in an epileptic woman using carbamazepine, 300 mg/day, and the other six in healthy women after unnoticed expulsion of the ICD. Sixteen spontaneous expulsions occurred. The most common reasons for removal were side effects, including bleeding disturbances, hormonal side effects and other medical reasons. The continuation rate was 72.6 per cent after one year. Three pelvic infections were observed.

PIP: 198 healthy, regularly menstruating women between 18-38 years of age volunteered for this study designed to evaluate a new type of levonorgestrel-releasing intracervical contraceptive device (LNG-ICD) which releases 20 mcg levonorgestrel/day. The insertion of the ICD occurred within 7 days of menstruation. Followup visits were 3 and 12 months following insertion. Subjects were asked to make additional visits if they experienced any problems with the ICD. Bimanual examination was performed, and blood pressure and body weight were measured at every visit. During the 12-month visit, a cervicovaginal smear was obtained. Life-table analysis of pregnancy and discontinuation rates were carried out according to the method of Potter. The observation period covered 1957 woman-months. The insertion of the ICD was considered to be easy by the majority of participants and by the doctor. No or minimal pain was felt by 56% and severe pain by 6% of the women. In 10% of the cases, the doctor considered the insertion to be difficult. In most of these cases, the internal os of the cervical canal was so tight that insertion was not possible without dilatation up to Hegar 4. 7 pregnancies occurred during this observation period, a net rate of 3.5. 6 of these 7 pregnancies occurred after an unnoticed expulsion of the device. 16 expulsions or partial expulsions occurred during the observation period. The primary reasons for termination were bleeding problems (4.6%), hormonal side effects (4.6%, and other medical reasons (2.6%). There was no termination because of amenorrhea. Additional reasons for termination were pain (2 subjects) and planning pregnancy (2 subjects). In 3 cases the ICD was removed because of an infection. No major changes in blood pressure were observed after 1 year of use of ICD. Cervicovaginal smears did not reveal any malignant or premalignant changes.