Five years' experience with a small intracervical/intrauterine levonorgestrel-releasing device.
OBJECTIVE
A randomized study was performed to compare the efficacy, safety and acceptability of a new model of an intracervical/intrauterine contraceptive device (ICD) releasing 20 microg of levonorgestrel (LNG) per day.


METHODS
The LNG-ICD was inserted in Group I into the cervical canal and in Group II into the uterine cavity. Group I included 151 women (age, 18-43 years) whereas Group II included 147 (age, 19-43 years). The number of nulliparous women was 145.


RESULTS
The 5-year results are presented here. The results showed a total continuation rate of 50%; the continuation rate in the cervical group and that in the uterine group were 53.6% and 46.3%, respectively--the difference being statistically insignificant (p=.3593). The main reason for termination was a wish for pregnancy, which is explained by the relatively young age and degree of nulliparity of the study population. During the first year, two pregnancies occurred in both groups. Two of these were ectopic, one in each group. The other two occurred after unnoticed expulsions. Thereafter, no pregnancies occurred. The cumulative gross rate for pregnancy was 1.3 and the Pearl index at 5 years was 0.425. The total expulsion rate was relatively high (11.1%). Expulsions occurring during the first few months of the first year were related to insertion. Removals because of bleeding and because of amenorrhea were low, the combined gross rate being 5.7 and the Pearl rate 1.8 at 5 years. Also, the gross rate of infection was low (0.7). The continuation was high in spite of a high rate of removals for planning pregnancy (15.4).


CONCLUSIONS
The method is safe and effective. There were only minor differences between the groups. There were no perforations and the incidence of infection was low. The device can also be used by young nulliparous women.
Pakarinen
Päivi
P
Department of Obstetrics and Gynecology, Helsinki University Central Hospital, 00029 HUS Helsinki, Finland. paivi.pakarinen@hus.fi
Luukkainen
Tapani
T
D000293:Adolescent; D000328:Adult; D003271:Contraceptive Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects; D020878:Device Removal / Q000706:statistics & numerical data; D004717:Endometrium / Q000000981:diagnostic imaging; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007433:Intrauterine Device Expulsion; D007436:Intrauterine Devices, Medicated / Q000706:statistics & numerical data*; D016912:Levonorgestrel / Q000008:administration & dosage* / Q000009:adverse effects; D011247:Pregnancy; D018873:Pregnancy Rate; D014463:Ultrasonography; D014592:Uterine Hemorrhage / Q000209:etiology
D003271:Contraceptive Agents, Female; D016912:Levonorgestrel