Document Detail


Five years' experience with a small intracervical/intrauterine levonorgestrel-releasing device.
MedLine Citation:
PMID:  16246659     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Päivi Pakarinen; Tapani Luukkainen
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial     Date:  2005-08-09
Journal Detail:
Title:  Contraception     Volume:  72     ISSN:  0010-7824     ISO Abbreviation:  Contraception     Publication Date:  2005 Nov 
Date Detail:
Created Date:  2005-10-25     Completed Date:  2007-04-05     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0234361     Medline TA:  Contraception     Country:  United States    
Other Details:
Languages:  eng     Pagination:  342-5     Citation Subset:  IM    
Affiliation:
Department of Obstetrics and Gynecology, Helsinki University Central Hospital, 00029 HUS Helsinki, Finland. paivi.pakarinen@hus.fi
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Contraceptive Agents, Female / administration & dosage*,  adverse effects
Device Removal / statistics & numerical data
Endometrium / ultrasonography
Equipment Design
Female
Follow-Up Studies
Humans
Intrauterine Device Expulsion
Intrauterine Devices, Medicated / utilization*
Levonorgestrel / administration & dosage*,  adverse effects
Pregnancy
Pregnancy Rate
Uterine Hemorrhage / etiology
Chemical
Reg. No./Substance:
0/Contraceptive Agents, Female; 797-63-7/Levonorgestrel

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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