Study Completed

Uterine Hemorrhage

Bayer Identifier:

15105

ClinicalTrials.gov Identifier:

NCT01295294

EudraCT Number:

2010-020922-16

EU CT Number:

Not Available

Management of initial bleeding/spotting associated with the levonorgestrel-releasing intrauterine system (MIRENA)

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

18 - 45 Years

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

Trial summary

Enrollment Goal

187

Trial Dates

March 2011 - December 2011

Phase

Phase 4

Could I Receive a placebo

Yes

Products

Mirena (Levonorgestrel IUS, BAY86-5028)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	Specialistlægesellskabet John Dræby ApS	Odense C, DK-5000, Denmark
Completed	Speciallæge Anette Peen	Århus C, DK-8000, Denmark
Completed	Dr Mary Short	Blackrock, Ireland
Completed	The Practrice	Mallow, Ireland
Completed	Langford Hall Medical Centre	Cork, Ireland
Completed	Speciallæge Lise Helmsøe-Zinck	Søborg, DK-2860, Denmark
Completed	Klinik for kvindesygdomme & graviditet	Skive, DK-7800, Denmark
Completed	Speciallæge Morten Ring	Ålborg, DK-9000, Denmark
Completed	Speciallæge Claus Christoffersen	København NV, DK-2400, Denmark
Completed	Medicus AS	Trondheim, 7012, Norway
Completed	Kvinnelegen i Hedmark	Elverum, 2403, Norway
Completed	Haugesund Gyn Klinikk AS	Haugesund, 5507, Norway

Primary Outcome

The primary efficacy variable will be the cumulative number of bleeding / spotting days
Time Frame:
During 90 day double-blind treatment period
Safety Issue:
No

Secondary Outcome

To describe and compare the bleeding patterns observed in women during treatment period
Time Frame:
90 day treatment period
Safety Issue:
No
To describe and compare the bleeding patterns observed in women during follow-up period
Time Frame:
During the 30 day follow-up period
Safety Issue:
No
Satisfaction with oral blinded study drug treatment for bleeding / spotting
Time Frame:
90 day treatment period
Safety Issue:
No
Occurrence of dysmenorrhea
Time Frame:
During 120 day study period
Safety Issue:
No
Continuation rate with study drug
Time Frame:
During the 90 day treatment period
Safety Issue:
No
Continuation rate with Mirena
Time Frame:
During 120 day study period
Safety Issue:
No
Adverse Events Collection
Time Frame:
Until day 120
Safety Issue:
Yes
Number of spotting-only days
Time Frame:
During the 90-day treatment period
Safety Issue:
No
Number of bleeding / spotting episodes
Time Frame:
During the 90-day treatment period
Safety Issue:
No
Length of bleeding / spotting episodes
Time Frame:
During the 90-day treatment period
Safety Issue:
No
Number of bleeding days with heavy intensity
Time Frame:
During the 90-day treatment period
Safety Issue:
No
Change in the number of B/S days between Day 60 and Day 90 of MIRENA use and the 30-day follow-up period
Time Frame:
Up to day 120
Safety Issue:
No
Satisfaction with levonorgestrel-releasing intrauterine system
Time Frame:
Up to day 120
Safety Issue:
No
Number of days of pain medication for dysmenorrhea during the 90 day treatment period
Time Frame:
During the 90-day treatment period
Safety Issue:
No
Number of bleeding-only days
Time Frame:
During the 90-day treatment period
Safety Issue:
No

Trial design

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.

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Double Blind

Assignment

Single Group Assignment

Trial Arms

Additional Information

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