NCT00393198 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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:
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, 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 intrauter

Multicenter Study to Investigate the Bleeding Profile and the Insertion Easiness in Women Inserted With a Second Consecutive MIRENA for Contraception or Menorrhagia

Details for clinical trial NCT00393198

Clinical trial NCT00393198 - References