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Uterine HemorrhagePhase 4NCT01295294

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

A Phase 4 study testing Tranexamic acid, Mefenamic acid and Mirena (Levonorgestrel IUS, BAY86-5028) in people with Uterine Hemorrhage, run by Bayer at 12 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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"). Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Uterine Hemorrhage
What is being tested?
Tranexamic acid, Mefenamic acid and Mirena (Levonorgestrel IUS, BAY86-5028)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
187 participants
Where
12 sitesin 3 countries
Study dates
Mar 2011to Dec 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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 locations and contacts

12 sites in 3 countries.

12 sites in 3 countries

Denmark6 sites

  • Study site

    Aalborg, DK-9000

  • Study site

    Århus C, DK-8000

  • Study site

    København NV, DK-2400

  • Study site

    Odense C, DK-5000

  • Study site

    Skive, DK-7800

  • Study site

    Søborg, DK-2860

Other trials in Denmark

Ireland3 sites

  • Study site

    Blackrock, Dublin

  • Study site

    Cork

  • Study site

    Mallow, Cork

Other trials in Ireland

Norway3 sites

  • Study site

    Elverum, 2403

  • Study site

    Haugesund, 5507

  • Study site

    Trondheim, 7012

Other trials in Norway

About this study

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.

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.

Being tested
Tranexamic acid, Mefenamic acid, Placebo, Mirena (Levonorgestrel IUS, BAY86-5028)
Keywords
Uterine Hemorrhage, Contraception, Contraceptive Methods, Intrauterine devices, Mirena
Medical subject headings
Uterine Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic acidDrug

    500 mg 3 times daily per oral during bleeding/spotting episodes

  • Mefenamic acidDrug

    500 mg 3 times daily per oral during bleeding/spotting episodes

  • PlaceboDrug

    3 times daily per oral during bleeding/spotting episodes

  • Mirena (Levonorgestrel IUS, BAY86-5028)Drug

    In vitro release rate 20 microgram/24 hours. Intrauterine system

Study groups in NCT01295294
Study groupRoleWhat they receive
tranexamic acid + Mirena (Levonorgestrel IUS, BAY86-5028)ExperimentalSubjects with successful MIRENA insertion will receive treatments with tranexamic acid
Receives: Drug: Tranexamic acid; Drug: Mirena (Levonorgestrel IUS, BAY86-5028)
mefenamic acid + Mirena (Levonorgestrel IUS, BAY86-5028)ExperimentalSubjects with successful MIRENA insertion will receive treatments with mefenamic acid
Receives: Drug: Mefenamic acid; Drug: Mirena (Levonorgestrel IUS, BAY86-5028)
placebo + Mirena (Levonorgestrel IUS, BAY86-5028)Placebo comparatorSubjects with successful MIRENA insertion will receive placebo
Receives: Drug: Placebo; Drug: Mirena (Levonorgestrel IUS, BAY86-5028)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary efficacy variable will be the cumulative number of bleeding / spotting days

    Measured: During 90 day double-blind treatment period

Secondary outcomes (15)

  1. To describe and compare the bleeding patterns observed in women during treatment period

    Measured: 90 day treatment period

  2. To describe and compare the bleeding patterns observed in women during follow-up period

    Measured: During the 30 day follow-up period

  3. Satisfaction with oral blinded study drug treatment for bleeding / spotting

    Measured: 90 day treatment period

  4. Occurrence of dysmenorrhea

    Measured: During 120 day study period

  5. Continuation rate with study drug

    Measured: During the 90 day treatment period

  6. Continuation rate with Mirena

    Measured: During 120 day study period

  7. Adverse Events Collection

    Measured: Until day 120

  8. Number of spotting-only days

    Measured: During the 90-day treatment period

  9. Number of bleeding / spotting episodes

    Measured: During the 90-day treatment period

  10. Length of bleeding / spotting episodes

    Measured: During the 90-day treatment period

  11. Number of bleeding days with heavy intensity

    Measured: During the 90-day treatment period

  12. Change in the number of B/S days between Day 60 and Day 90 of MIRENA use and the 30-day follow-up period

    Measured: Up to day 120

  13. Satisfaction with levonorgestrel-releasing intrauterine system

    Measured: Up to day 120

  14. Number of days of pain medication for dysmenorrhea during the 90 day treatment period

    Measured: During the 90-day treatment period

  15. Number of bleeding-only days

    Measured: During the 90-day treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
187 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01295294
Sponsor's protocol ID
15105
Other IDs
2010-020922-16
Status last verified
Nov 2014
First submitted
11 Feb 2011
Last updated
4 Nov 2014
Results posted
No
Data monitoring committee
No

Publications

  • Sordal T, Inki P, Draeby J, O'Flynn M, Schmelter T. Management of initial bleeding or spotting after levonorgestrel-releasing intrauterine system placement: a randomized controlled trial. Obstet Gynecol. 2013 May;121(5):934-941. doi: 10.1097/AOG.0b013e31828c65d8.

    PubMed 23635728

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tranexamic acid, Mefenamic acid and Mirena (Levonorgestrel IUS, BAY86-5028) in people with Uterine Hemorrhage, run by Bayer at 12 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Denmark, Ireland, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary efficacy variable will be the cumulative number of bleeding / spotting days (time frame: During 90 day double-blind treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01295294, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2014.

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