drugset / Trial / NCT00393198
Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the bleeding pattern during the last 3 months of the first MIRENA® and the first year of the second MIRENA® use.
Timeline
- Start
- 2006-10
- Primary completion
- 2012-10
- Completion
- 2012-10
Publications
- Results Heikinheimo O, Inki P, Kunz M, Parmhed S, Anttila AM, Olsson SE, Hurskainen R, Gemzell-Danielsson K. Double-blind, randomized, placebo-controlled study on the effect of misoprostol on ease of consecutive insertion of the levonorgestrel-releasing intrauterine system. Contraception. 2010 Jun;81(6):481-6. doi: 10.1016/j.contraception.2010.01.020. Epub 2010 Mar 1.
- Results Gemzell-Danielsson K, Inki P, Boubli L, O'Flynn M, Kunz M, Heikinheimo O. Bleeding pattern and safety of consecutive use of the levonorgestrel-releasing intrauterine system (LNG-IUS)--a multicentre prospective study. Hum Reprod. 2010 Feb;25(2):354-9. doi: 10.1093/humrep/dep426. Epub 2009 Dec 1.
- Results Heikinheimo O, Inki P, Kunz M, Gemzell-Danielsson K. Predictors of bleeding and user satisfaction during consecutive use of the levonorgestrel-releasing intrauterine system. Hum Reprod. 2010 Jun;25(6):1423-7. doi: 10.1093/humrep/deq079. Epub 2010 Apr 8.
- Heikinheimo O, Inki P, Schmelter T, Gemzell-Danielsson K. Bleeding pattern and user satisfaction in second consecutive levonorgestrel-releasing intrauterine system users: results of a prospective 5-year study. Hum Reprod. 2014 Jun;29(6):1182-8. doi: 10.1093/humrep/deu063. Epub 2014 Mar 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Levonorgestrel | Small molecule | 20 ug | Other |
| Comparator | Misoprostol | Other / unclassified | 400 ug | Subcutaneous |