Double-blind, randomized, placebo-controlled study on the effect of misoprostol on ease of consecutive insertion of the levonorgestrel-releasing intrauterine system.

Abstract

BACKGROUND:

Misoprostol has been studied intensively to produce cervical dilatation. To date, no studies have evaluated the effectiveness, safety or acceptability of this treatment for repeat intrauterine device insertions.

STUDY DESIGN:

This study was a randomized, double-blind, placebo-controlled trial on the consecutive use of the levonorgestrel-releasing intrauterine system (LNG-IUS). Women who had used their first LNG-IUS for 4 years and 3 to 9 months and opted for an immediate replacement with a second LNG-IUS received a single sublingual dose of 400 mcg misoprostol or placebo 3 h prior to the LNG-IUS insertion.

RESULTS:

The proportion of easy insertions as judged by the investigator was 93% (40/43) in subjects randomized to misoprostol and 91% (42/46) in the placebo group (p=1.0 for the difference of proportions). No or mild pain at insertion was reported by 37% and 35% of subjects in the misoprostol and placebo groups, respectively. However, adverse events related to the study drug were more common in the misoprostol group.

CONCLUSION:

Sublingual misoprostol did not have a significant effect on the ease of insertion in subjects having a repeat insertion of the LNG-IUS.

• Authors: Oskari Heikinheimo, Pirjo Inki, Michael Kunz, Sule Parmhed, Anna-Maija Anttila, Sven-Eric Olsson, Ritva Hurskainen, Kristina Gemzell-Danielsson
• Journal: Contraception (Contraception) Vol. 81 Issue 6 Pg. 481-6 (Jun 2010) ISSN: 1879-0518 [Electronic] United States
• PMID: 20472114 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Contraceptive Agents, Female
• Misoprostol
• Levonorgestrel

Topics

• Administration, Sublingual
• Adult
• Cervix Uteri (drug effects)
• Contraceptive Agents, Female (administration & dosage)
• Dilatation (methods)
• Double-Blind Method
• Female
• Humans
• Intrauterine Devices, Medicated (adverse effects)
• Levonorgestrel (administration & dosage)
• Misoprostol (administration & dosage, adverse effects, therapeutic use)
• Pain Measurement
• Pelvic Pain (prevention & control)
• Premedication