check_circleStudy Completed

Menorrhagia, Contraceptive Devices, Intrauterine

Bayer Identifier:

90589

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study to compare efficacy and safety of Levonorgestrel-releasing Intrauterine system to a three-month administration of danazol in women with menorrhagia

Trial purpose

Please see attached Study Results Summary below.

Key Participants Requirements

Sex

N/A

Age

N/A

Trial summary

Enrollment Goal
151
Trial Dates
November 1999 - November 2002
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

Randomized, open-label, multicenter study comparing the efficacy and safety of Mirena to a three-month administration of danazol followed by a 3-month observation period in women aged over 30 with functional menorrhagia
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.