Return to search results       New search       Contact for this trial
 
 
 
Study to evaluate efficacy, safety, and pharmacokinetics of Levonorgestrel-releasing intrauterine system SH G 00650 A
 
 
 
Trial ID: 90870
 
 
 
Please see attached Study Results Summary below.
 
 
 
Official Title: A Multicenter, Open-Label, Non-Randomized Study of SH G 00650 A (Levonorgestrel Intrauterine System) in Parous Women Seeking Contraception to Evaluate its Efficacy, Safety, and Pharmacokinetic Profile When Inserted for 12 months
 
 
 
Product: Mirena (Levonorgestrel IUS, BAY86-5028)
 
 
 
Indication/Disease: Contraception
Contraceptive Devices, Intrauterine
 
 
 
Trial Status: Completed
Trial Start Date: 2001-04
Trial End Date: 2003-06 (Actual)
 
 
 
Trial Phase: Phase 3
 
 
 
Trial Design:
Trial Type: Interventional
Intervention:
Participants: 482
 
 
 
Primary Outcome:
 
 
 
Secondary Outcome:
 
 
 
Eligibility Criteria:
Minimum Age:
Maximum Age:
Gender:
 
 
 
Sponsor: Bayer
 
 
 
Results Synopsis: PDF File
 
 
 
Relevant Links: Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to marketed products.
 
 
 
   
This information is provided by Bayer under Bayer's disclaimer for publication of clinical trial information.