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Completed

NCT Number: NCT01295294

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

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.

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Key information

Conditions

Uterine Hemorrhage Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Aalborg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

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

mefenamic acid

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: During 90 day double-blind treatment period

Secondary outcomes

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

    Time frame: 90 day treatment period

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

    Time frame: During the 30 day follow-up period

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

    Time frame: 90 day treatment period

  4. Occurrence of dysmenorrhea

    Time frame: During 120 day study period

  5. Continuation rate with study drug

    Time frame: During the 90 day treatment period

  6. Continuation rate with Mirena

    Time frame: During 120 day study period

  7. Adverse Events Collection

    Time frame: Until day 120

  8. Number of spotting-only days

    Time frame: During the 90-day treatment period

  9. Number of bleeding / spotting episodes

    Time frame: During the 90-day treatment period

  10. Length of bleeding / spotting episodes

    Time frame: During the 90-day treatment period

  11. Number of bleeding days with heavy intensity

    Time frame: 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

    Time frame: Up to day 120

  13. Satisfaction with levonorgestrel-releasing intrauterine system

    Time frame: Up to day 120

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

    Time frame: During the 90-day treatment period

  15. Number of bleeding-only days

    Time frame: During the 90-day treatment period

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 14, 2011
Registry last updated
Nov 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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