Management of Initial Bleeding/Spotting Associated With the Levonorgestrel-releasing Intrauterine System (MIRENA)

Uterine Hemorrhage Clinical Trial

Official title:

International, Prospective, Double-blind, 3-arm Comparative, Randomized, Placebo-controlled Phase IV Study on the Effect of Counseling and Either Tranexamic Acid or Mefenamic Acid or Placebo, on the Management of Bleeding/Spotting in Women Using the Levonorgestrel-releasing Intrauterine System (MIRENA) for Contraception.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01295294
• Other study ID #: 15105
• Secondary ID: 2010-020922-16
• Status: Completed
• Phase: Phase 4
• First received: February 11, 2011
• Last updated: November 2, 2014
• Start date: March 2011
• Est. completion date: December 2011

Study information

• Verified date: November 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ministry of HealthIreland: Irish Medicines BoardNorway: Norwegian Medicines AgencyTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to investigate if the study drugs (tranexamic acid or mefenamic acid) can control irregular bleeding during the first 3 months of using Mirena. The study drugs tested are tested against placebo ("dummy medication not containing any active drug"). Treatment period is followed by a one-month period when study drugs are not taken but Mirena use is continued.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Signed and dated informed consent

• Healthy female subjects requesting contraception

• Age: 18 - 45 years inclusive

• Successful interval insertion of MIRENA

• History of regular cyclic menstrual periods

• Normal or clinically insignificant cervical smear not requiring further follow up

Exclusion Criteria:

• Pregnancy or lactation

• Climacteric symptoms prior to the screening visit

• Known or suspected clinically significant ovarian cysts, endometrial polyps, fibroids, or other genital organ pathology, that, in the opinion of the investigator, may interfere with the assessment of the bleeding profile during the study

• Undiagnosed abnormal genital bleeding

• Current or history of thrombembolic disease, or established risk factors for venous thromboembolism

• Current migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia, or exceptionally severe headaches

• Hypersensitivity to any ingredient of the investigational medicinal products or the non-investigational medicinal product

• Daily or frequent use of a nonsteroidal anti-inflammatory drug (NSAIDs) for any condition

• Not willing to use nonsteroidal anti-inflammatory drug (NSAIDs) medication as pain medication during the double blind treatment period

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Uterine Hemorrhage

Intervention

Drug:
• Tranexamic acid
500 mg 3 times daily per oral during bleeding/spotting episodes
• Mefenamic acid
500 mg 3 times daily per oral during bleeding/spotting episodes
• Placebo
3 times daily per oral during bleeding/spotting episodes
• Mirena (Levonorgestrel IUS, BAY86-5028)
In vitro release rate 20 microgram/24 hours. Intrauterine system

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Denmark,  Ireland,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy variable will be the cumulative number of bleeding / spotting days		During 90 day double-blind treatment period	No
Secondary	To describe and compare the bleeding patterns observed in women during treatment period		90 day treatment period	No
Secondary	To describe and compare the bleeding patterns observed in women during follow-up period		During the 30 day follow-up period	No
Secondary	Satisfaction with oral blinded study drug treatment for bleeding / spotting		90 day treatment period	No
Secondary	Occurrence of dysmenorrhea		During 120 day study period	No
Secondary	Continuation rate with study drug		During the 90 day treatment period	No
Secondary	Continuation rate with Mirena		During 120 day study period	No
Secondary	Adverse Events Collection		Until day 120	Yes
Secondary	Number of spotting-only days		During the 90-day treatment period	No
Secondary	Number of bleeding / spotting episodes		During the 90-day treatment period	No
Secondary	Length of bleeding / spotting episodes		During the 90-day treatment period	No
Secondary	Number of bleeding days with heavy intensity		During the 90-day treatment period	No
Secondary	Change in the number of B/S days between Day 60 and Day 90 of MIRENA use and the 30-day follow-up period		Up to day 120	No
Secondary	Satisfaction with levonorgestrel-releasing intrauterine system		Up to day 120	No
Secondary	Number of days of pain medication for dysmenorrhea during the 90 day treatment period		During the 90-day treatment period	No
Secondary	Number of bleeding-only days		During the 90-day treatment period	No

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