check_circleStudy Completed

Contraception, Contraceptive Devices, Intrauterine

Bayer Identifier:

90870

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study to evaluate efficacy, safety, and pharmacokinetics of Levonorgestrel-releasing intrauterine system SH G 00650 A

Trial purpose

Please see attached Study Results Summary below.

Key Participants Requirements

Sex

N/A

Age

N/A

Trial summary

Enrollment Goal
482
Trial Dates
April 2001 - June 2003
Phase
Phase 3
Could I Receive a placebo
N/A
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteer
N/A

Primary Outcome

Secondary Outcome

Trial design

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
Trial Type
Interventional
Intervention Type
N/A
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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.